A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ADmIRe  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03831191
• Other study ID #: 17104
• Secondary ID: I9N-MC-FCAB2018-
• Status: Terminated
• Phase: Phase 2
• Start date: February 12, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have diagnosis of AD >= 12 months according to the American Academy of Dermatology criteria.

• Participants must have moderate to severe AD at screening and randomization.

• Participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance).

Exclusion Criteria:

• Participants must not have concurrent treatment with topical or systemic treatments for AD.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LY3375880
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	Buenos Aires
Argentina	DOM- Centro de Reumatologia	Caba	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad Autonoma Buenos Aires
Argentina	Instituto de Neumonología y Dermatología	Ciudad Autonoma Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Ciudad Autonoma Buenos Aires
Argentina	Parra Dermatología	Mendoza
Argentina	Centro Medico Privado de Reumatologia	Tucuman
Austria	LKH Feldkirch	Feldkirch	Vorarlberg
Austria	Universitätsklinikum Graz	Graz	Steiermark
Austria	Sozialmed. Zentrum Ost - Donauspital	Wien
Canada	The Guenther Dermatology Research Centre	London	Ontario
Czechia	Sanatorium Profesora Arenbergera	Praha 1
Czechia	Clintrial, s.r.o.	Praha 10	Hl. M. Praha
France	CHU de Nice Hopital de L'Archet	Nice cedex 3
Germany	Dermatologikum Hamburg	Hamburg
Germany	TFS Trial Form Support GmbH	Hamburg
Hungary	UNO Medical Trials Kft.	Budapest
Hungary	Oroshaza Varosi Onkormanyzat Korhaza	Oroshaza	Bekes
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jasz-Nagykun-Szolnok
Hungary	MedMare Bt	Veszprem
Italy	Polic.Umberto I -Univ. La Sapienza	Roma
Italy	Policlinico di Tor Vergata	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Japan	Yasumoto Dermatology Clinic	Chikushino	Fukuoka
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Matsuda Tomoko Dematological Clinic	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya	Saitama
Japan	Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Kume Clinic	Nishi-ku Sakai-shi	Osaka
Japan	Meiwa Hospital	Nishinomiya	Hyogo
Japan	Takagi Dermatological Clinic	Obihiro	Hokkaido
Japan	Oita University Hospital	Yufu-shi	Oita
Mexico	Derma Norte del Bajío, S.C.	Aguascalientes
Mexico	Grupo Medico Camino S.C.	México City	Distrito Federal
Puerto Rico	Office of Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	Office of Dr. Alma M. Cruz	Carolina
Puerto Rico	Ponce School of Medicine CAIMED Center	Ponce
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
Puerto Rico	GCM Medical Group PSC	San Juan
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Clinica Universidad De Navarra	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clinica Universitaria De Navarra	Pamplona	Navarra
United States	Piedmont Plastic Surgery and Dermatology	Charlotte	North Carolina
United States	Tien Q. Nguyen, MD inc. DBA First OC Dermatology	Fountain Valley	California
United States	Center for Clinical Studies	Houston	Texas
United States	Clinical Partners LLC	Johnston	Rhode Island
United States	Dermatology Research Associates	Los Angeles	California
United States	Hightower Clinical Trial Services	Norman	Oklahoma
United States	Quest Dermatology Research	Northridge	California
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	ActivMed Practices & Research, Inc	Portsmouth	New Hampshire
United States	Dermatology and Skin Cancer Specialists	Rockville	Maryland
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Integrative Skin Science and Research	Sacramento	California
United States	The South Bend Clinic	South Bend	Indiana
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Mexico,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a =2 Point Improvement	vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.	Week 16
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)	EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a = 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.	Week 16
Secondary	Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)	The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It 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 in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.	Week 16
Secondary	Percentage of Participants Achieving vIGA-AD of 0	vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.	Week 16
Secondary	Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score	EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(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 (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.	Baseline, Week 16
Secondary	Mean Change From Baseline in SCORAD	The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It 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 in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.	Baseline, Week 16
Secondary	Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52	vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.	Week 52
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCt,ss) of LY3375880	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCt,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).	Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose

External Links

•   A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis