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

NCT05911841 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: 18569J4E-MC-FR01FR01 ISAJ4E-MC-IMMB Master Protocol2022-502888-38-00
• Study Type: interventional
• Target: 234
• Locations: 9 countries
• Sites: 66

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (EASI) 75 (≥75% Reduction in EASI Score) at Week 16

  The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

  Week 16

Secondary Outcomes (10)

• Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-50 (≥ 50% Reduction in EASI Score) at Week 16

  Week 16

• Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-90 (≥ 90% Reduction in EASI Score) at Week 16

  Week 16

• Percentage of Biologic and Small Molecule Naive Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 at Week 16

  Week 16

• Percentage of Biologic and Small Molecule Naive Participants Achieving SCORAD-90 at Week 16

  Week 16

• Percentage of Biologic and Small Molecule Naive Participants Achieving Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 at Week 16

  Week 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.

Drug: LY3454738; Drug: Placebo

75 mg LY3454738

EXPERIMENTAL

Participants received 75 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and received 150 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Drug: LY3454738

300 mg LY3454738

EXPERIMENTAL

Participants received 300 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and continued receiving 300 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Drug: LY3454738

800 mg LY3454738

EXPERIMENTAL

Participants received 800 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and were re-randomized to either receive 800 mg of LY3454738 or placebo administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.

Drug: LY3454738

Interventions

LY3454738 DRUG

Administered SC

300 mg LY3454738; 75 mg LY3454738; 800 mg LY3454738; Placebo

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (66)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72217, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Allergy and Asthma Specialist

Owensboro, Kentucky, 42301, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

Metropolitan Dermatology - Clark

Kenilworth, New Jersey, 07033, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, 17011, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Rejuvenation Dermatology

Calgary, Alberta, T2W 4X9, Canada

Location

Rejuvenation Dermatology

Edmonton, Alberta, T5J 3S9, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

Hamilton Allergy

Hamilton, Ontario, L8S 1G5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

FACET Dermatology

Toronto, Ontario, M4E 1R7, Canada

Location

Alpha Recherche Clinique

Québec, G2J 0C4, Canada

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, Vas County, 9700, Hungary

Location

Medmare Bt

Veszprém, Veszprém City, 8200, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Yasumoto Dermatology Clinic

Chikushino-shi, Fukuoka, 818-0083, Japan

Location

Takagi Dermatological Clinic

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 190-0023, Japan

Location

Centro de Atención en Enfermedades Inflamatorias CATEI

Guadalajara, Jalisco, 44630, Mexico

Location

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico

Location

RM Pharma Specialists

Mexico City, Mexico City, 03100, Mexico

Location

Trials in Medicine

Mexico City, Mexico City, 06700, Mexico

Location

Eukarya PharmaSite

Monterrey, Nuevo León, 64718, Mexico

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020, Mexico

Location

Diamond Clinic

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Specderm Poznanska

Bialystok, Podlaskie Voivodeship, 15-375, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland

Location

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

Bupyeong-gu, Incheon-gwangyeoksi [Incheon], 21431, South Korea

Location

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, 15355, South Korea

Location

Pusan National University Hospital

Busan, Pusan-Kwangyǒkshi, 49241, South Korea

Location

Chung-Ang University Hospital

Dongjak-gu, Seoul-teukbyeolsi [Seoul], 06973, South Korea

Location

National Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 01812, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

New Taipei Municipal TuCheng Hospital

New Taipei City, New Taipei, 236, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taichung, 402, Taiwan

Location

Tri-Service General Hospital

Taipei City, Taipei, 114, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch

Hsinchu, 300, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 21, 2023
• Primary Completion: October 10, 2024
• Study Completion: March 14, 2025
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

KR (6); HU (5); US (13); CA (8); ME (7); PL (6); JP (6); TW (9); CN (6)