Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03428100
Other study ID # 16841
Secondary ID I4V-MC-JAIN2017-
Status Completed
Phase Phase 3
First received
Last updated
Start date May 15, 2018
Est. completion date April 20, 2023

Study information

Verified date April 15, 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.


Recruitment information / eligibility

Status Completed
Enrollment 463
Est. completion date April 20, 2023
Est. primary completion date November 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months. - Have had inadequate response to existing topical (applied to the skin) medications within 6 months preceding screening. - Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period). - Agree to use emollients daily. - Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past. Exclusion Criteria: - Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. - A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past. - Participants who are currently experiencing a skin infection that requires treatment, or are currently being treated, with topical or systemic antibiotics. - Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). - Have been treated with the following therapies: - Monoclonal antibody for less than 5 half-lives prior to randomization. - Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization. - Received oral corticosteroids within 4 weeks prior to randomization or parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. - Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization. - Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg. - Have had major surgery within the past eight weeks or are planning major surgery during the study. - Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. - Have a history of recurrent (= 2) VTE or are considered at high risk of VTE as deemed by the investigator. - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. - Have a current or recent and/or clinically serious viral, bacterial, fungal, or parasitic infection including but not limited to herpes zoster, tuberculosis. - Have specific laboratory abnormalities related to thyroid, renal and liver function, or blood cells. - Have received certain treatments that are contraindicated. - Pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Baricitinib
Administered orally.
Placebo
Administered orally.
Topical corticosteroid
Administered as standard-of-care.

Locations

Country Name City State
Austria Universitätsklinikum Graz Graz Steiermark
Austria Universitätsklinik Innsbruck Innsbruck Tyrol
Austria AKH Wien
Austria KA Rudolfstiftung Wien
Austria Sozialmed. Zentrum Ost - Donauspital Wien
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Universitair Ziekenhuis Gent Gent
Belgium UZ Leuven - Campus Sint-Rafaël Leuven
Brazil Faculdade de Ciências Médicas - UNICAMP Campinas Sao Paulo
Brazil Hospital Moinhos de Vento - Instituto de Educação e Pesquisa Porto Alegre Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Hospital das Clinicas da FMRP Ribeirao Preto SP
Brazil CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA Rio de Janeiro RJ
Brazil IDERJ - Instituto de Dermatologia e Estética do Brasil Rio de Janeiro RJ
Brazil Fundação Faculdade de Medicina do ABC Santo André Sao Paulo
Brazil Hospital da Clinicas da Faculdade de Medicina da USP Sao Paulo
Brazil Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd Vitoria ES
Finland Helsinki University Central Hospital Helsinki
Finland Terveystalo Tampere Tampere Irkanmaa
Finland Hospital Mehiläinen Neo Turku
France CHU de Besancon Hopital Jean Minjoz Besancon Cedex
France CHU de Bordeaux Hopital Saint Andre Bordeaux Cedex
France Hôpital C. HURIEZ Lille
France Hôpital Emile Muller Mulhouse
France Chru De Nantes Hotel-Dieu Nantes Cedex 1
France CHU de Nice Hopital de L'Archet Nice cedex 3
France Hôpital de Pontchaillou Rennes Cedex 9
France Hopital Sainte Anne (H.I.A) Toulon Cedex 9
France Hopital Larrey Toulouse cedex 9
France Centre Hospitalier de Valence Valence
Germany Fachklinik Bad Bentheim Bad Bentheim Nordrhein-Westfalen
Germany Charité Universitätsmedizin Berlin Berlin
Germany St Josef-Hospital Bochum Bochum Nordrhein-Westfalen
Germany Universitätsklinikum Bonn Bonn Nordrhein-Westfalen
Germany Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude Buxtehude Niedersachsen
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany Universitaetsklinikum Essen Essen Nordrhein-Westfalen
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen
Germany Universitätsklinikum Hamburg - Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Hannover Niedersachsen
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany Universitätsklinikum Jena Jena Thüringen
Germany Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Mainz Rheinland-Pfalz
Germany Klinikum Rechts der Isar der TU München München Bayern
Germany Universitätsklinikum Münster Münster Nordrhein-Westfalen
Germany Klinische Forschung Osnabrück Osnabrück Niedersachsen
Germany Hautarztpraxis Dr. Leitz und Kollegen Stuttgart Baden-Württemberg
Italy Azienda Ospedaliera Umberto I Ancona
Italy Spedali Civili - Universita degli Studi Brescia
Italy Fondazione Universitaria degli Studi G D'Annunzio Chieti
Italy Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia Milano Milan
Italy Azienda Ospedaliera di Perugia Perugia
Italy Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia Reggio Emilia
Italy Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza Roma Rome
Italy Policlinico di Tor Vergata Roma
Italy Ospedale Clinicizzato San Donato San Donato Milanese Milan
Italy Ospedale Policlinico Giambattista Rossi, Borgo Roma Verona
Japan Yanagihara dermatology clinic Ainokawa, Ichikawa-shi Chiba
Japan Iidabashi Clinic Chiyoda-ku Tokyo
Japan Nihonbashi Sakura Clinic Chuo-ku Tokyo
Japan Sumire Dermatology Clinic Edogawa-ku Tokyo
Japan Fumimori Clinic Fukuoka-shi Fukuoka
Japan Noguchi Dermatology Kashima-machi, Kamimashiki-gun Kumamoto
Japan Yoshioka Dermatology Clinic Neyagawa-shi Osaka
Japan Kume Clinic Nishi-ku Sakai-shi Osaka
Japan Queen's Square Dermatology and Allergology Nishi-ku, Yokohama-city Kanagawa
Japan Sanrui Dermatology Clinic Ohmiya-ku,Saitama-shi Saitama
Japan Tachikawa Dermatology Clinic Tachikawa-shi Tokyo
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Bravis Ziekenhuis Bergen op Zoom
Netherlands Amphia Ziekenhuis Breda
Poland NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm Bialystok
Poland Centrum Badan Klinicznych, PI House Gdansk
Poland Centrum Medyczne Angelius Provita Katowice
Poland Barbara Rewerska DIAMOND CLINIC Krakow
Poland Dermed Centrum Medyczne Sp. z o.o. Lodz
Poland Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii Olsztyn
Poland DermoDent, Centrum Medyczne Czajkowscy Osielsko
Poland LASER CLINIC Specjalistyczne Gabinety Lekarskie Szczecin
Poland Wojskowy Instytut Medyczny CSK MON Warsaw
Poland Centralny Szpital Kliniczny MSW Klinika Dermatologii Warszawa
Russian Federation First Moscow State Medical University n.a. Sechenov Moscow
Russian Federation State scientific centre for dermatovenerology and cosmetolog Moscow
Russian Federation LLC ArsVitae NorthWest Saint-Petersburg
Russian Federation LLC Medical Center "Kurator" Saint-Petersburg
Russian Federation SPb SBHI Skin-venerologic dispensary #10 St. Petersburg
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital Univ. Puerta de Hierro Majadahonda Madrid
Spain Hospital de Manises Manises Valencia
Spain Hospital Universitario Quiron Madrid Pozuelo de Alarcon Madrid
Spain Hospital Universitario de Torrejon Torrejón de Ardoz Madrid
Spain Hospital Universitario Dr Pesset Valencia
Switzerland Inselspital Bern Bern
Switzerland Kantonsspital St. Gallen St. Gallen Sankt Gallen
Switzerland Universitätsspital Zürich Zürich
United Kingdom The Dudley Group NHS Foundation Trust Dudley West Midlands
United Kingdom West Glasgow Ambulatory Care Hospital Glasgow Lanarkshire
United Kingdom Whipps Cross University Hospital Leytonstone London
United Kingdom Broadgreen Hospital Liverpool Merseyside
United Kingdom Guys/St. Thomas Hospital London Surrey
United Kingdom Salford Royal NHS Foundation Trust Salford Greater Manchester

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Incyte Corporation

Countries where clinical trial is conducted

Austria,  Belgium,  Brazil,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Poland,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 16
Secondary Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score.
Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who permanently discontinue, are rescued, or are without at least 1 post-baseline observation.
Week 16
Secondary Percentage of Participants Achieving IGA of 0 or 1 With a = 2 Point Improvement The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Week 16
Secondary Percentage of Participants Achieving EASI90 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI90 is defined as a = 90% improvement from baseline in the EASI score. Week 16
Secondary Percent Change From Baseline in EASI Score The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease).
Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline score and baseline score-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD75 responder is defined as a participant who achieves a = 75% improvement from baseline in the SCORAD score.
Week 16
Secondary Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. Week 16
Secondary Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.
LS Mean were calculated using an MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in Skin Pain NRS Skin Pain NRS is a participant-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.
LS Mean were calculated using MMRM model includes treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving IGA of 0 or 1 With a >=2-point Improvement The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Week 24
Secondary Percentage of Participants Achieving EASI50 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI50 is defined as a = 50% improvement from baseline in the EASI score. Week 16
Secondary Percentage of Participants Achieving EASI75 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 24
Secondary Percentage of Participants Achieving IGA of 0 The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Week 16
Secondary Change From Baseline in SCORAD The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving SCORAD90 The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a = 90% improvement from baseline in the SCORAD score. Week 16
Secondary Change From Baseline in Body Surface Area (BSA) Affected The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment Percentage of participants developing skin infections requiring antibiotic treatment. Week 16
Secondary Mean Number of Days Without Topical Corticosteroids (TCS) Use The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors. Week 16
Secondary Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights) Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model. Week 16
Secondary Percent Change From Baseline in Itch NRS The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percent Change From Baseline in Itch NRS at Week 24 The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 24
Secondary Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by visit-interactions as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in the Patient Global Impression of Severity - Atopic Dermatitis (PGI-S-AD) Score The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the Hospital Anxiety Depression Scale (HADS) The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in the Dermatology Life Quality Index (DLQI) The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Secondary Percentage of Participants Achieving EASI75 The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 52
Secondary Percent Change From Baseline in Itch NRS at Week 52 The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 52
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF). Week 68
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF). Week 104
Secondary Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Week 68
Secondary Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Week 104
Secondary Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 68
Secondary Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 104
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF). Week 68
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 104
Secondary Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 68
Secondary Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 104
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 68 Participants Not Entered Into Substudy (All Participants) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 68
Secondary Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 Participants Not Entered Into Substudy (All Participants) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 104
Secondary Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 68
Secondary Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants) The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF. Week 104
Secondary Percentage of Participants With A Response of EASI75 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 68
Secondary Percentage of Participants With A Response of EASI75 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants) The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Week 104
Secondary Time to Retreatment (Time to IGA =3) Randomized Downtitration (All Patients Entering the Substudy) Participants who entered the Substudy and relapsed with an IGA =3. Week 52 Up to Week 200
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2