A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: LY3375880Drug: Placebo
- Registration Number
- NCT03831191
- Lead Sponsor
- Eli Lilly and Company
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 136
- 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).
- Participants must not have concurrent treatment with topical or systemic treatments for AD.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg LY3375880 LY3375880 Induction Period: Participants received 50 mg LY3375880 administered SC Q4W. 150 mg LY3375880 LY3375880 Induction Period: Participants received 150 mg LY3375880 administered SC Q4W. 600 mg LY3375880 LY3375880 Induction Period: Participants received 600 mg LY3375880 administered SC Q4W. Placebo Placebo Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52 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.
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75) Week 16 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.
Percentage of Participants Achieving vIGA-AD of 0 Week 16 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.
Mean Change From Baseline in SCORAD Baseline, Week 16 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.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) Week 16 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.
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Baseline, Week 16 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.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880 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 Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,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).
Trial Locations
- Locations (58)
Sanatorium Profesora Arenbergera
🇨🇿Praha 1, Czechia
Clintrial, s.r.o.
🇨🇿Praha 10, Hl. M. Praha, Czechia
CHU de Nice Hopital de L'Archet
🇫🇷Nice cedex 3, France
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Buenos Aires Skin
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
🇦🇷Tucuman, Argentina
Dermatologikum Hamburg
🇩🇪Hamburg, Germany
Parra Dermatología
🇦🇷Mendoza, Argentina
TFS Trial Form Support GmbH
🇩🇪Hamburg, Germany
Dermatology and Skin Cancer Specialists
🇺🇸Rockville, Maryland, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Clinica Universidad De Navarra
🇪🇸Madrid, Spain
Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Oita University Hospital
🇯🇵Yufu-shi, Oita, Japan
Clinica Universitaria De Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Ponce School of Medicine CAIMED Center
🇵🇷Ponce, Puerto Rico
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Matsuda Tomoko Dematological Clinic
🇯🇵Fukuoka, Japan
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
🇺🇸Fountain Valley, California, United States
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Hightower Clinical Trial Services
🇺🇸Norman, Oklahoma, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Oroshaza Varosi Onkormanyzat Korhaza
🇭🇺Oroshaza, Bekes, Hungary
Sumire Dermatology Clinic
🇯🇵Edogawa-ku, Tokyo, Japan
LKH Feldkirch
🇦🇹Feldkirch, Vorarlberg, Austria
UNO Medical Trials Kft.
🇭🇺Budapest, Hungary
DOM- Centro de Reumatologia
🇦🇷Caba, Buenos Aires, Argentina
MedMare Bt
🇭🇺Veszprem, Hungary
Grupo Medico Camino S.C.
🇲🇽México City, Distrito Federal, Mexico
Universitätsklinikum Graz
🇦🇹Graz, Steiermark, Austria
Allergo-Derm Bakos Kft
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Sozialmed. Zentrum Ost - Donauspital
🇦🇹Wien, Austria
Kume Clinic
🇯🇵Nishi-ku Sakai-shi, Osaka, Japan
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
ActivMed Practices & Research, Inc
🇺🇸Portsmouth, New Hampshire, United States
Piedmont Plastic Surgery and Dermatology
🇺🇸Charlotte, North Carolina, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Buenos Aires, Argentina
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Instituto de Neumonología y Dermatología
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
The Guenther Dermatology Research Centre
🇨🇦London, Ontario, Canada
Policlinico di Tor Vergata
🇮🇹Roma, Lazio, Italy
Polic.Umberto I -Univ. La Sapienza
🇮🇹Roma, Italy
Yasumoto Dermatology Clinic
🇯🇵Chikushino, Fukuoka, Japan
Takagi Dermatological Clinic
🇯🇵Obihiro, Hokkaido, Japan
Meiwa Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Office of Dr. Samuel Sanchez PSC
🇵🇷Caguas, Puerto Rico
Office of Dr. Alma M. Cruz
🇵🇷Carolina, Puerto Rico
Derma Norte del Bajío, S.C.
🇲🇽Aguascalientes, Mexico
Dokkyo Medical University Saitama Medical Center
🇯🇵Koshigaya, Saitama, Japan
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Quest Dermatology Research
🇺🇸Northridge, California, United States
Psoriahue Medicina Interdisciplinaria
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Clinical Partners LLC
🇺🇸Johnston, Rhode Island, United States
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico