Clinical trial NCT03831191: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
atopic eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
timeFrame: Week 16
measure: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
timeFrame: Week 16
measure: Percentage of Participants Achieving vIGA-AD of 0
timeFrame: Week 16
measure: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 16
measure: Mean Change From Baseline in SCORAD
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
timeFrame: Week 52
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
timeFrame: 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
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc
state: New Hampshire
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery and Dermatology
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Norman
country: United States
facility: Hightower Clinical Trial Services
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Caba
country: Argentina
facility: DOM- Centro de Reumatologia
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto de Neumonología y Dermatología
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Feldkirch
country: Austria
facility: LKH Feldkirch
state: Vorarlberg
city: Wien
country: Austria
facility: Sozialmed. Zentrum Ost - Donauspital
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
state: Hl. M. Praha
city: Praha 1
country: Czechia
facility: Sanatorium Profesora Arenbergera
city: Nice cedex 3
country: France
facility: CHU de Nice Hopital de L'Archet
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Oroshaza
country: Hungary
facility: Oroshaza Varosi Onkormanyzat Korhaza
state: Bekes
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Veszprem
country: Hungary
facility: MedMare Bt
city: Roma
country: Italy
facility: Policlinico di Tor Vergata
state: Lazio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Roma
country: Italy
facility: Polic.Umberto I -Univ. La Sapienza
city: Chikushino
country: Japan
facility: Yasumoto Dermatology Clinic
state: Fukuoka
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Meiwa Hospital
state: Hyogo
city: Kyoto-shi
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita
city: Nishi-ku Sakai-shi
country: Japan
facility: Kume Clinic
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Edogawa-ku
country: Japan
facility: Sumire Dermatology Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Matsuda Tomoko Dematological Clinic
city: México City
country: Mexico
facility: Grupo Medico Camino S.C.
state: Distrito Federal
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajío, S.C.
city: Caguas
country: Puerto Rico
facility: Office of Dr. Samuel Sanchez PSC
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universitaria De Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universidad De Navarra
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: