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

NCT ID: NCT03831191

Last Updated: 2021-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2020-02-27

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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50 mg LY3375880

Induction Period:

Participants received 50 mg LY3375880 administered SC Q4W.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

150 mg LY3375880

Induction Period:

Participants received 150 mg LY3375880 administered SC Q4W.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

600 mg LY3375880

Induction Period:

Participants received 600 mg LY3375880 administered SC Q4W.

Group Type EXPERIMENTAL

LY3375880

Intervention Type DRUG

Administered SC

Placebo

Induction Period:

Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3375880

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Tien Q. Nguyen, MD inc. DBA First OC Dermatology

Fountain Valley, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Quest Dermatology Research

Northridge, California, United States

Site Status

Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

The South Bend Clinic

South Bend, Indiana, United States

Site Status

Dermatology and Skin Cancer Specialists

Rockville, Maryland, United States

Site Status

ActivMed Practices & Research, Inc

Portsmouth, New Hampshire, United States

Site Status

Piedmont Plastic Surgery and Dermatology

Charlotte, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

Hightower Clinical Trial Services

Norman, Oklahoma, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Clinical Partners LLC

Johnston, Rhode Island, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

DOM- Centro de Reumatologia

CABA, Buenos Aires, Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Parra Dermatología

Mendoza, , Argentina

Site Status

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, , Argentina

Site Status

Universitätsklinikum Graz

Graz, Styria, Austria

Site Status

LKH Feldkirch

Feldkirch, Vorarlberg, Austria

Site Status

Sozialmed. Zentrum Ost - Donauspital

Vienna, , Austria

Site Status

The Guenther Dermatology Research Centre

London, Ontario, Canada

Site Status

Clintrial, s.r.o.

Prague, Hl. M. Praha, Czechia

Site Status

Sanatorium Profesora Arenbergera

Prague, , Czechia

Site Status

CHU de Nice Hopital de L'Archet

Nice, , France

Site Status

Dermatologikum Hamburg

Hamburg, , Germany

Site Status

TFS Trial Form Support GmbH

Hamburg, , Germany

Site Status

Oroshaza Varosi Onkormanyzat Korhaza

Orosháza, Bekes County, Hungary

Site Status

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status

UNO Medical Trials Kft.

Budapest, , Hungary

Site Status

MedMare Bt

Veszprém, , Hungary

Site Status

Policlinico di Tor Vergata

Rome, Lazio, Italy

Site Status

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status

Polic.Umberto I -Univ. La Sapienza

Roma, , Italy

Site Status

Yasumoto Dermatology Clinic

Chikushino-shi, Fukuoka, Japan

Site Status

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan

Site Status

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status

Meiwa Hospital

Nishinomiya, Hyōgo, Japan

Site Status

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Oita University Hospital

Yufu-shi, Oita Prefecture, Japan

Site Status

Kume Clinic

Nishi-ku Sakai-shi, Osaka, Japan

Site Status

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Site Status

Sumire Dermatology Clinic

Edogawa-ku, Tokyo, Japan

Site Status

Matsuda Tomoko Dematological Clinic

Fukuoka, , Japan

Site Status

Grupo Medico Camino S.C.

Mexico City, Mexico City, Mexico

Site Status

Derma Norte del Bajío, S.C.

Aguascalientes, , Mexico

Site Status

Office of Dr. Samuel Sanchez PSC

Caguas, PR, Puerto Rico

Site Status

Office of Dr. Alma M. Cruz

Carolina, PR, Puerto Rico

Site Status

Ponce School of Medicine CAIMED Center

Ponce, PR, Puerto Rico

Site Status

GCM Medical Group PSC

San Juan, PR, Puerto Rico

Site Status

Clinical Research Puerto Rico, Inc.

San Juan, , Puerto Rico

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Clinica Universitaria De Navarra

Pamplona, Navarre, Spain

Site Status

Clinica Universidad De Navarra

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/4hXeeEjeZhqtnDW4onAZx3#?postal=

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

Other Identifiers

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I9N-MC-FCAB

Identifier Type: OTHER

Identifier Source: secondary_id

2018-002401-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17104

Identifier Type: -

Identifier Source: org_study_id

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