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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04178967
Other study ID # 17802
Secondary ID 2019-002933-12J2
Status Completed
Phase Phase 3
First received
Last updated
Start date October 29, 2019
Est. completion date April 28, 2022

Study information

Verified date April 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date April 28, 2022
Est. primary completion date July 12, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Male or female adults and adolescents (=12 years and =40 kg) - Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit - Eczema Area and Severity Index (EASI) score =16 at the baseline visit - Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit - =10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit - History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable Exclusion Criteria: - Prior treatment with dupilumab or tralokinumab - Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit - Treatment with any of the following agents within 4 weeks prior to the baseline visit: - Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.) - Phototherapy and photochemotherapy (PUVA) for AD - Treatment with the following prior to the baseline visit: - An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer - Cell-depleting biologics, including to rituximab, within 6 months of baseline - Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer - Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study - Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma - Evidence of active acute or chronic hepatitis - History of human immunodeficiency virus (HIV) infection or positive HIV serology - History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin - Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Lebrikizumab
Subcutaneous injection
Other:
Placebo
Subcutaneous Injection

Locations

Country Name City State
Bulgaria DCC Sveti Georgi Plovdiv
Bulgaria Alexandrovska University Hospital Sofia
Bulgaria Diagnostic and Consultation Center 14 Sofia
Bulgaria Euro Derma clinic Sofia
Bulgaria Medical centre Alitera-Med EOOD Sofia
Bulgaria Military Medical Academy Sofia
Canada Simcoderm Medical & Surgical Dermatology Centre Barrie Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada North York Research Inc. North York Ontario
Canada Ottawa Allergy Research Corp Ottawa Ontario
Canada Dr. Chih-ho Hong Medical Inc. Surrey British Columbia
Canada K. Papp Clinical Research Waterloo Ontario
Germany licca Fachklinik Augsburg Bayern
Germany Praxis Dr. Michael Dietlen Augsburg
Germany Fachklinik Bad Bentheim Bad Bentheim Nordrhein-Westfalen
Germany Charité Universitätsmedizin Berlin Campus Buch Berlin
Germany ISA GmbH Berlin
Germany Praxis für Ganzheitliche Dermatologie im Ärztehaus Berlin
Germany Hautzentrum im Jahrhunderthaus Bochum Nordrhein-Westfalen
Germany Elbe Klinikum Buxtehude Buxtehude Niedersachsen
Germany Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH Darmstadt Hessen
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen
Germany Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Baden-Württemberg
Germany TFS Trial Form Support GmbH Hamburg
Germany Universitätsklinikum Hamburg Hamburg
Germany Studienzentrum Dr.Beate Schwarz Langenau Baden-Württemberg
Germany SIBAmed Studienzentrum GmbH & Co. KG Leipzig Saxony
Germany Universität Leipzig - Universitätsklinikum Leipzig Sachsen
Germany Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein
Germany Universitätsklinikum Münster Münster Nordrhein-Westfalen
Germany Klinische Forschung Osnabrück Osnabrück Niedersachsen
Germany Hautarztpraxis am Löwenmarkt Stuttgart Baden-Württemberg
Mexico Derma Norte del Bajío, S.C. Aguascalientes
Mexico Clinica De Enfermedades Cronicas y Procedimientos Especiales Morelia Michoacan Morelia
Singapore Kk Women'S and Childrens Hospital Singapore
Singapore National Skin Centre NSC Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Taiwan Kaohsiung Medical University Chung-Ho Institutional Review B Kaohsiung
Taiwan Taipei Medical University- Shuang Ho Hospital New Taipei City
Taiwan Kaohsiung Chang Gung Memorial Hospital Niaosong Dist Kaohsiung City
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan China Medical University Hospital Taichung City
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Memorial Hospital - Linkou Taoyuan City
Ukraine Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2 Kharkiv
Ukraine Rivne Regional Dermatology and Venereology Dispensary Rivne
Ukraine Treatment-diagnostic center PE "Asclepius" Uzhhorod
Ukraine Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council Zaporizhzhya
United States Georgia Pollens Clinical Research Centers, Inc Albany Georgia
United States Arlington Research Center, Inc Arlington Texas
United States Bakersfield Dermatology and Skin Cancer Medical Group Bakersfield California
United States Meridian Clinical Research Baton Rouge Louisiana
United States Great Lakes Research Group, Inc. Bay City Michigan
United States ActivMed Practices and Research Beverly Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Dermatology & Laser Center of Charleston Charleston South Carolina
United States OnSite Clinical Solutions Charlotte North Carolina
United States Clarkston Skin Research Clarkston Michigan
United States Dermatology and Skin Surgery Center Exton Pennsylvania
United States Clinical Physiology Associates, Clinical Study Center Fort Myers Florida
United States Innovate Research, LLC Fort Worth Texas
United States Center For Dermatology Clinical Research, Inc. Fremont California
United States Woodward Centre Fresno California
United States Associated Skin Care Specialists Fridley Minnesota
United States Palmetto Clinical Trial Services Greenville South Carolina
United States DermDOX Hazleton Pennsylvania
United States Direct Helpers Medical Center Hialeah Florida
United States The Community Research of South Florida Hialeah Florida
United States Solutions Through Advanced Research, Inc. Jacksonville Florida
United States Forest Hills Dermatology Group Kew Gardens New York
United States Dermatology Research Associates Los Angeles California
United States LA Universal Research Center, INC Los Angeles California
United States Marietta Dermatology Clinical Research Marietta Georgia
United States University of Utah MidValley Dematology Murray Utah
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States Kansas City Dermatology, PA Overland Park Kansas
United States Austin Institute for Clinical Research Pflugerville Texas
United States Northwest Arkansas Clinical Trials Center Rogers Arkansas
United States Arlington Dermatology Rolling Meadows Illinois
United States Central Dermatology PC Saint Louis Missouri
United States University Clinical Trials, Inc. San Diego California
United States San Luis Dermatology & Laser Clinic San Luis Obispo California
United States Advanced Medical Research Sandy Springs Georgia
United States Investigate MD Scottsdale Arizona
United States Dermatology Associates Seattle Washington
United States NorthShore University HealthSystem Skokie Illinois
United States Peak Research LLC Upper Saint Clair Pennsylvania
United States Wilmington Dermatology Center Wilmington North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Dermira, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Germany,  Mexico,  Singapore,  Taiwan,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. Baseline to Week 16
Primary Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (=75% Reduction in EASI Score) From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a = 75% reduction from baseline in the EASI score.
Baseline to Week 16
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 2 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. Baseline to Week 2
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 4 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. Baseline to Week 4
Secondary Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 16 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. Baseline to Week 16
Secondary Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a = 90% reduction from baseline in the EASI score.
Baseline to Week 16
Secondary Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =4-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =5-points at Baseline Who Achieve a =4-point Reduction in Pruritus NRS Score From Baseline to Week 16 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 16
Secondary Percentage Change in EASI Score From Baseline to Week 16 The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe).
LS Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in Percent Body Surface Area (BSA) at Week 16 The BSA affected by AD will be assessed for 4 separate body regions: 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. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. Baseline, Week 16
Secondary Percentage of Participants Achieving EASI-90 From Baseline to Week 4 The EASI assesses objective physician estimates of 2 dimensions of AD - 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 to 72 (severe).
The EASI-90 responder is defined as a participant who achieves a = 90% reduction from baseline in the EASI score.
Baseline to Week 4
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
Secondary Percentage of Participants Achieving =4-point Improvement in DLQI From Baseline to Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. Baseline to Week 16
Secondary Percentage of Participants With a DLQI Total Score of =4-point at Baseline Achieving =4-point Improvement in DLQI From Baseline to Week 16 The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. Baseline to Week 16
Secondary Percentage Change in Sleep-loss Score From Baseline to Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. Baseline, Week 16
Secondary Change From Baseline in Sleep-loss Score at Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. Baseline, Week 16
Secondary Percentage of Participants With a Sleep-loss Score =2 Points at Baseline Who Achieve a =2 Points Reduction From Baseline to Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. Baseline to Week 16
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 1
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 2
Secondary Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 4
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 1
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 2
Secondary Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 4
Secondary Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough) C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52. Predose at Week 52
Secondary Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score) The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin 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-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).
The EASI-75 responder is defined as a participant who achieves a = 75% reduction from baseline in the EASI score.
Baseline to Week 52
Secondary Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a =2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a =2-point Improvement From Baseline at Week 52 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. Baseline to Week 52
Secondary Percentage of Participants From Those With a Pruritus NRS of =4-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 52
Secondary Percentage of Participants From Those With a Pruritus NRS of =5-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52 Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Baseline to Week 52
Secondary Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52 SCORAD is a validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 52
Secondary Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health 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. A higher score indicates better health state.
LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS) The EQ-5D-5L is a 2-part measurement. The second part is assessed using a 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 Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed. Baseline, Week 16
Secondary Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Anxiety at Week 16 - Adults PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Depression at Week 16- Adolescents PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in PROMIS Depression at Week 16- Adults PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate. Baseline, Week 16
Secondary Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control.
LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.
Baseline, Week 16
Secondary Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
Baseline, Week 16
See also
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