CClinicalTrials.gg
TerminatedNCT07020351Updated Jun 13, 2025

A Master Protocol of Multiple Interventions for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis.

A Phase 2 interventional study of LY3454738 in Atopic Dermatitis, sponsored by Eli Lilly and Company. Terminated at 66 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Screening

Why this study was terminated
The study was terminated for lack of efficacy.

From the registry’s dates

  • Primary completion was Oct 2024, 1 year 11 months ago, and no results have been posted to the registry.
  • Registered 1 year 11 months after the study started (first participant enrolled Jun 2023, registered Jun 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
317
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This platform trial is designed to enable the investigation of many interventions for AD by means of the introduction of new interventional specific addenda (ISAs) over time. At the inception of this platform trial, at least 1 ISA will be available. Additional ISAs will be added to the platform trial over time.

02

Conditions studied

03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 317 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Present with a diagnosis of atopic dermatitis (AD) at least 12 months prior to screening

    • Eczema Area and Severity Index (EASI) score ≥12
    • Validated Investigator Global Assessment AD (vIGA-AD) score ≥3
    • ≥10% of BSA involvement (per EASI BSA)
  • Are candidates for systemic therapy, and have a history, documented by a physician and/or the investigator, of inadequate response to existing topical medications within 6 months preceding screening.

Exclusion criteria

Exclusion Criteria:

  • Have a history of eczema herpeticum:

    • any episode within 12 months prior to screening, or
    • 2 or more episodes during lifetime
  • Are currently experiencing or have a history of concomitant skin conditions other than AD, for example, psoriasis or cutaneous lupus, that, in the opinion of the investigator, would interfere with evaluations of the effect of study intervention on AD.
  • Are currently experiencing or have a history of erythrodermic, refractory, or unstable skin disease which requires frequent hospitalizations or IV treatment and, in the opinion of the investigator, could interfere with study participation
  • Are currently experiencing a skin infection that requires treatment with, or is currently being treated with, topical or systemic antibiotics.

Note: Participants who fail screening due to this criterion should not be rescreened until at least 4 weeks after screen failure and at least 2 weeks after resolution of the infection.

05

Study design

Phase
Phase 2
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
317 participants (actual)

Study arms

  • Experimental
    LY FR01 ISA LY3454738

    Participants are assigned to the LY3454738 ISA.

    Drug: LY3454738

Interventions

  • DrugLY3454738

    Administered subcutaneously (SC)

06

What researchers measure

Primary outcomes

  1. Number of Participants Allocated to FR01 ISA

    Time frame: Screening to Randomization (Up to 90 Days)

07

Study locations

66 sites
  • Johnson Dermatology
    Fort Smith, Arkansas 72916, United States
  • Arkansas Research Trials
    North Little Rock, Arkansas 72217, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • Encore Medical Research
    Hollywood, Florida 33024, United States
  • Conquest Research
    Winter Park, Florida 32789, United States
  • Allergy and Asthma Specialist
    Owensboro, Kentucky 42301, United States
  • Revival Research Institute, LLC
    Troy, Michigan 48084, United States
  • ActivMed Practices & Research, Inc.
    Portsmouth, New Hampshire 03801, United States
  • Metropolitan Dermatology - Clark
    Kenilworth, New Jersey 07033, United States
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
  • DermDox Centers for Dermatology
    Camp Hill, Pennsylvania 17011, United States
  • Progressive Clinical Research
    San Antonio, Texas 78213, United States
  • Center for Clinical Studies
    Webster, Texas 77598, United States
  • Rejuvenation Dermatology
    Calgary, Alberta T2W 4X9, Canada
  • Rejuvenation Dermatology
    Edmonton, Alberta T5J 3S9, Canada
  • Wiseman Dermatology Research Inc.
    Winnipeg, Manitoba R3M 3Z4, Canada
  • CCA Medical Research
    Ajax, Ontario L1S 7K8, Canada
  • Hamilton Allergy
    Hamilton, Ontario L8S 1G5, Canada
  • Lynderm Research Inc.
    Markham, Ontario L3P 1X3, Canada
  • FACET Dermatology
    Toronto, Ontario M4E 1R7, Canada
  • Alpha Recherche Clinique
    Quebec, G2J 0C4, Canada
  • Xiangya Hospital Central South University
    Changsha, Hunan 410008, China
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, Jiangsu 212000, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
  • Huashan Hospital, Fudan University
    Shanghai, Shanghai 200040, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310014, China
  • Renmin Hospital of Wuhan University
    Wuhan, 430060, China
  • Allergo-Derm Bakos Kft
    Szolnok, Jász-Nagykun-Szolnok 5000, Hungary
  • Somogy Megyei Kaposi Mór Oktató Kórház
    Kaposvár, Somogy 7400, Hungary
  • Markusovszky Egyetemi Oktatokorhaz
    Szombathely, Vas 9700, Hungary
  • Medmare Bt
    Veszprém, Veszprém City 8200, Hungary
  • Debreceni Egyetem Klinikai Kozpont
    Debrecen, 4032, Hungary
  • Yasumoto Dermatology Clinic
    Chikushino-city, Fukuoka 818-0083, Japan
  • Takagi Dermatological Clinic
    Obihiro-shi, Hokkaido 080-0013, Japan
  • Nomura Dermatology Clinic
    Yokohama-city, Kanagawa 221-0825, Japan
  • Dermatology and Ophthalmology Kume Clinic
    Sakai City, Osaka 593-8324, Japan
  • Nihonbashi Sakura Clinic
    Chuo-ku, Tokyo 103-0025, Japan
  • Tachikawa Dermatology Clinic
    Tachikawa, Tokyo 190-0023, Japan
  • The Catholic University of Korea, Incheon St. Mary's Hospital
    Bupyeong-gu, Incheon-gwangyeoksi [Incheon] 21431, Korea, Republic of
  • Korea University Ansan Hospital
    Ansan-si, Kyǒnggi-do 15355, Korea, Republic of
  • Pusan National University Hospital
    Busan, Pusan-Kwangyǒkshi 49241, Korea, Republic of
  • Chung-Ang University Hospital
    Dongjak-gu, Seoul-teukbyeolsi [Seoul] 06973, Korea, Republic of
  • National Medical Center
    Seoul, Seoul-teukbyeolsi [Seoul] 01812, Korea, Republic of
  • Hallym University Kangnam Sacred Heart Hospital
    Seoul, Seoul-teukbyeolsi [Seoul] 07441, Korea, Republic of
  • Cryptex Investigación Clínica S.A. de C.V.
    Cuauhtémoc, Ciudad De México, Distrito Federal 06100, Mexico
  • RM Pharma Specialists
    Mexico City, Distrito Federal 03100, Mexico
  • Trials in Medicine
    Mexico City, Distrito Federal 06700, Mexico
  • Centro de Atención en Enfermedades Inflamatorias CATEI
    Guadalajara, Jalisco 44630, Mexico
  • Eukarya PharmaSite
    Monterrey, Nuevo León 64718, Mexico
  • Scientia Investigacion Clinica S.C.
    Chihuahua, 31207, Mexico
  • Centro de Investigacion Clinica de Oaxaca
    Oaxaca, 68020, Mexico
  • MICS Centrum Medyczne Warszawa
    Warszawa, Mazowieckie 00-874, Poland
  • Diamond Clinic
    Krakow, Małopolskie 31-559, Poland
  • Specderm Poznanska
    Bialystok, Podlaskie 15-375, Poland
  • Centrum Badan Klinicznych PI-House sp. z o.o.
    Gdansk, Pomorskie 80-546, Poland
  • "DERMED" Centrum Medyczne Sp. z o.o.
    Lodz, Łódzkie 90-265, Poland
  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
    Lodz, Łódzkie 90-436, Poland
  • Chang Gung Memorial Hospital at Kaohsiung
    Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan
  • New Taipei Municipal TuCheng Hospital
    New Taipei City, New Taipei 236, Taiwan
  • Chung Shan Medical University Hospital
    Taichung City, Taichung 402, Taiwan
  • Tri-Service General Hospital
    Taipei City, Taipei 114, Taiwan
  • National Taiwan University Hospital - Hsinchu branch
    Hsinchu, 300, Taiwan
  • Taipei Medical University Shuang Ho Hospital
    New Taipei, 235, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch
    Taoyuan, 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07020351
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 13, 2025
Start date
Jun 21, 2023
Primary completion
Oct 10, 2024
Completion
Dec 3, 2024
Last update
Jun 13, 2025

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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