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NCT05911841 | ACTIVE NOT RECRUITING | Atopic Dermatitis

A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Sponsor:

Eli Lilly and Company

Brief Summary:

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

Condition or disease

Atopic Dermatitis

Intervention/treatment

LY3454738

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 236 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : 2023-06-21
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Are candidates for systemic therapy.
  • ISA specific
    • * Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit
      • * EASI score greater than or equal to (≥)16
      • * vIGA-AD score ≥3, and
      • * ≥10% of BSA involvement (per EASI BSA).
      • * Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
      Exclusion Criteria
      • ISA specific
        • * Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
        • * Are currently being treated with topical or systemic therapy
        • * Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Location Details

NCT05911841

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arkansa

Johnson Dermatology

Fort Smith, Arkansa, United States, 72916

Not yet recruiting

United States, Arkansa

Arkansas Research Trials

North Little Rock, Arkansa, United States, 72217

Not yet recruiting

United States, California

Dermatology Research Associates

Los Angeles, California, United States, 90045

Not yet recruiting

United States, Florida

Encore Medical Research

Hollywood, Florida, United States, 33024

Not yet recruiting

United States, Florida

Conquest Research

Winter Park, Florida, United States, 32789

Not yet recruiting

United States, Kentucky

Allergy and Asthma Specialist

Owensboro, Kentucky, United States, 42301

Not yet recruiting

United States, Road cancer

Revival Research Institute, LLC

Troy, Road cancer, United States, 48084

Not yet recruiting

United States, New Hampshire

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, United States, 03801

Not yet recruiting

United States, New Jersey

Metropolitan Dermatology - Clark

Kenilworth, New Jersey, United States, 07033

Not yet recruiting

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

Not yet recruiting

United States, Pennsylvania

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, United States, 17011

Not yet recruiting

United States, Texas

Progressive Clinical Research

San Antonio, Texas, United States, 78213

Not yet recruiting

United States, Texas

Center for Clinical Studies

Webster, Texas, United States, 77598

Not yet recruiting

Canada, Alberta

Rejuvenation Dermatology

Calgary, Alberta, Canada, T2W 4X9

Not yet recruiting

Canada, Alberta

Rejuvenation Dermatology

Edmonton, Alberta, Canada, Have a stick

Not yet recruiting

Canada, Manitoba

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada, R3M 3Z4

Not yet recruiting

Canada, Ontario

CCA Medical Research

Ajax, Ontario, Canada, L1s 7K8

Not yet recruiting

Canada, Ontario

Hamilton Allergy

Hamilton, Ontario, Canada, L8S 1G5

Not yet recruiting

Canada, Ontario

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X3

Not yet recruiting

Canada, Ontario

FACET Dermatology

Toronto, Ontario, Canada, M.

Not yet recruiting

Canada,

Alpha Clinical Research

Quebec, Canada, G2J 0C4

Not yet recruiting

China, Hunan

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Not yet recruiting

China, Jiangsu

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China, 212000

Not yet recruiting

China, Shaanxi

The First Affiliated Hospital of Xi'an Jiaotong University

XI'an, Shaanxi, China, 710061

Not yet recruiting

China, Shanghai

hu Ashan hospital, F U egg university

Shanghai, Shanghai, China, 200040

Not yet recruiting

China, Zhejiang

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310014

Not yet recruiting

China,

Renmin Hospital of Wuhan University

Wuhan, China, 430060

Not yet recruiting

Hungary, Jász-Nagykun-Szolnok

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000

Not yet recruiting

Hungary, Somogy

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, Somogy, Hungary, 7400

Not yet recruiting

Hungary, Vas

Markusovszky University Education

Szombathely, Vas, Hungary, 9700

Not yet recruiting

Hungary, Veszprém City

MEDMARE BT

Veszprém, Veszprém City, Hungary, 8200

Not yet recruiting

Hungary,

University of Debrecen Clinical Center

Debrecen, Hungary, 4032

Not yet recruiting

Japan, Fukuoka

Yasumoto Dermatology Clinic

Chikusthino-City, Fukuoka, Japan, 818-0083

Not yet recruiting

Japan, Hokkaido

Takagi Dermatological Clinic

Mr. Obihiro, Hokkaido, Japan, 080-0013

Not yet recruiting

Japan, Kanagawa

Nomura Dermatology Clinic

Yokohama-city, Kanagawa, Japan, 221-0825

Not yet recruiting

Japan, Osaka

Dermatology and Ophthalmology Kume Clinic

Sakai City, Osaka, Japan, 593-8324

Not yet recruiting

Japan, Tokyo

Nihonbashi Sakura Cii c

C-Cry, Tokyo, Japan, 103-0025

Not yet recruiting

Japan, Tokyo

Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan, 190-0023

Not yet recruiting

Korea, Republic of, Incheon-gwangyeoksi [Incheon]

The Catholic University of Korea, Incheon St. Mary's Hospital

Bupyeong-Gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21431

Not yet recruiting

Korea, Republic of, Kyǒnggi-do

Korea University Ansan Hospital

Aas-si, Kyǒnggi-do, Korea, Republic of, 15355

Not yet recruiting

Korea, Republic of, Pusan-kalganyǒkshi

Pusan National University Hospital

Busan, Pusan-Karganǒkshi, Korea, Republic of, 49241

Not yet recruiting

Korea, Republic of, Seoul-teukbyeolsi [Seoul]

Chung-the University Hospital

Dongjak-Gu, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06973

Not yet recruiting

Korea, Republic of, Seoul-teukbyeolsi [Seoul]

National Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 01812

Not yet recruiting

Korea, Republic of, Seoul-teukbyeolsi [Seoul]

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 07441

Not yet recruiting

Mexico, Federal district

Cryptex Research Clinical S.A. of C.V.

Cuauhtémoc, Mexico City, Federal District, Mexico, 06100

Not yet recruiting

Mexico, Federal district

RM Pharma Specialists

Mexico City, Federal District, Mexico, 03100

Not yet recruiting

Mexico, Federal district

Trials in Medicine

Mexico City, Federal District, Mexico, 06700

Not yet recruiting

Mexico, Jalisco

Catei inflammatory disease care

Guadalajara, Jalisco, Mexico, 44630

Not yet recruiting

Mexico, Nuevo León

Eukarya PharmaSite

Monterrey, Nuevo León, Mexico, 64718

Not yet recruiting

Mexico,

Science Investigacion Clinica S.C.

Chihuahua, Mexico, 31207

Not yet recruiting

Mexico,

Oaxaca Clinical Research Center

Oaxaca, Mexico, 68020

Not yet recruiting

Poland, Masovian

Micrs medical center Warsaw

Warsaw, Masovian Voivodeship, Poland, 00-874

Not yet recruiting

Poland, Lesser Poland

Diamond Clinic

Krakow, Lesser Poland, Poland, 31-559

Not yet recruiting

Poland, Podlasie

Specderm Pamen

Bialystok, Podlasie, Poland, 15-375

Not yet recruiting

Poland, Pomeranian

The Clinical Clinical Badan of PI-House sp. of o.o.

Gdansk, Pomeranian, Poland, 80-546

Not yet recruiting

Poland, Łódź

"Dermed" Centrum Medyczne Sp. z o.o.

Lodz, Łódź, Poland, 90-265

Not yet recruiting

Poland, Łódź

Dermoklinika - Centrum Medyczne Spółka Cywilna M. Kierstst, J. Narbutt, A. Lesiak

Lodz, Łódź, Poland, 90-436

Not yet recruiting

Taiwan, composed

Changel

Niao City, Goversors, Taiwan, 83301

Not yet recruiting

Taiwan, New Taipei

New Taipei Municipal TuCheng Hospital

New Taipei City, New Taipei, Taiwan, 236

Not yet recruiting

Taiwan, Taichung

Chung Shan Medical University Hospital

Taichung City, Taichung, Taiwan, 402

Not yet recruiting

Taiwan, Taipei

Tri-Service General Hospital

Taipei City, Taipei, Taiwan, 114

Not yet recruiting

Taiwan,

National Taiwan University Hospital - Hsinchu branch

H die N places, Taiwan, 300

Not yet recruiting

Taiwan,

Taipei Medical University Shuang ho hospital hospital hospital hospital

New Taipei, Taiwan, 235

Not yet recruiting

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10002

Not yet recruiting

Taiwan,

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Not yet recruiting

Taiwan,

Chang Gung Medical Foundation-Linkou Branch

taoyuan, Taiwan, 333