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

Last updated: November 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Terminated

Phase

2

Condition

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Rash

Treatment

LY3454738

Placebo

Clinical Study ID

NCT05911841
18569
FR01 ISA
J4E-MC-IMMB Master Protocol
2022-502888-38-00
J4E-MC-FR01
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are candidates for systemic therapy.

ISA specific:

  • Have moderate-to-severe AD, defined as meeting all of the following criteria, at thefirst 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 ofthe first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.

Exclusion

Exclusion Criteria:

ISA specific:

  • Have, in the screening period, any of the skin conditions, infections, or medicalconditions listed under master IMMB.

  • Are currently being treated with topical or systemic therapy

  • Recent treatment with experimental (biologics and/or small molecules) - doesn'tapply for subset of participants who must have been exposed to biologics and/orsmall molecules.

Study Design

Total Participants: 234
Treatment Group(s): 2
Primary Treatment: LY3454738
Phase: 2
Study Start date:
June 21, 2023
Estimated Completion Date:
March 14, 2025

Connect with a study center

  • Rejuvenation Dermatology

    Calgary, Alberta T2W 4X9
    Canada

    Site Not Available

  • Rejuvenation Dermatology

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Rejuvenation Dermatology

    Calgary 5913490, Alberta 5883102 T2W 4X9
    Canada

    Site Not Available

  • Rejuvenation Dermatology

    Edmonton 5946768, Alberta 5883102 T5J 3S9
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg 6183235, Manitoba 6065171 R3M 3Z4
    Canada

    Site Not Available

  • CCA Medical Research

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Hamilton Allergy

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Parson's Dermatology & Cosmetics

    Sudbury, Ontario P3E 5M4
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • CCA Medical Research

    Ajax 5882873, Ontario 6093943 L1S 7K8
    Canada

    Site Not Available

  • Hamilton Allergy

    Hamilton 5969782, Ontario 6093943 L8S 1G5
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto 6167865, Ontario 6093943 M4E 1R7
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Quebec, G2J 0C4
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Québec 6325494, G2J 0C4
    Canada

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wu Han, Hubei 430060
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha 1815577, Hunan 1806691 410008
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang 1784642, Jiangsu 1806260 212000
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710061
    China

    Site Not Available

  • Huashan Hospital Affiliated Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, 430060
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan 1791247, 430060
    China

    Site Not Available

  • Allergo-Derm Bakos Kft

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Allergo-Derm Bakos Kft

    Szolnok 715126, Jász-Nagykun-Szolnok 719637 5000
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy 7400
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár 3050616, Somogy County 3045226 7400
    Hungary

    Site Not Available

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, Vas 9700
    Hungary

    Site Not Available

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely 3044310, Vas County 3043047 9700
    Hungary

    Site Not Available

  • Medmare Bt

    Veszprém, Veszprém City 8200
    Hungary

    Site Not Available

  • Medmare Bt

    Veszprém 3042929, Veszprém City 8200
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen 721472, 4032
    Hungary

    Site Not Available

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Aou Ospedali Riuniti Umberto I

    Ancona, Marche 60126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

    Ancona, Marche 60126
    Italy

    Site Not Available

  • Humanitas

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Ospedale Le Scotte

    Siena, Toscana 53100
    Italy

    Site Not Available

  • Yasumoto Dermatology Clinic

    Chikushino-city, Fukuoka 818-0083
    Japan

    Site Not Available

  • Yasumoto Dermatology Clinic

    Chikushino-shi 1864572, Fukuoka 1863958 818-0083
    Japan

    Site Not Available

  • Takagi Dermatology

    Obihiro-shi, Hokkaido 080-0013
    Japan

    Active - Recruiting

  • Takagi Dermatological Clinic

    Obihiro-shi, Hokkaido 2130037 080-0013
    Japan

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama-city, Kanagawa 221-0825
    Japan

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama 1848354, Kanagawa 1860291 221-0825
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Site Not Available

  • Kume Clinic

    Sakai City, Osaka 593-8324
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai 1853195, Osaka 1853904 593-8324
    Japan

    Site Not Available

  • Tachikawa Dermatology Clinic

    Tachikawa, Tokyo 190-0023
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 1850144 103-0025
    Japan

    Site Not Available

  • Tachikawa Dermatology Clinic

    Tachikawa 11611487, Tokyo 1850144 190-0023
    Japan

    Site Not Available

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

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

    Site Not Available

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

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

    Site Not Available

  • Korea University Ansan Hospital

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

    Site Not Available

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi 49241
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

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

    Site Not Available

  • Chungang University Hospital

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

    Site Not Available

  • Chung-Ang University Hospital

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

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

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

    Site Not Available

  • National Medical Center

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

    Site Not Available

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

    Cuauhtémoc, Distrito Federal 06100
    Mexico

    Site Not Available

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

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • Hospital de Jesús Nazareno

    Mexico City, Distrito Federal 06090
    Mexico

    Site Not Available

  • RM Pharma Specialists

    Mexico City, Distrito Federal 03100
    Mexico

    Site Not Available

  • Trials in Medicine

    Mexico City, Distrito Federal 06700
    Mexico

    Site Not Available

  • Centro de Atención en Enfermedades Inflamatorias CATEI

    Guadalajara, Jalisco 44638
    Mexico

    Site Not Available

  • Centro de Atención en Enfermedades Inflamatorias CATEI

    Guadalajara 4005539, Jalisco 4004156 44630
    Mexico

    Site Not Available

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

    Cuauhtémoc, Ciudad de México, Mexico City 3527646 06100
    Mexico

    Site Not Available

  • RM Pharma Specialists

    Mexico City 3530597, Mexico City 3527646 03100
    Mexico

    Site Not Available

  • Trials in Medicine

    Mexico City 3530597, Mexico City 3527646 06700
    Mexico

    Site Not Available

  • Eukarya PharmaSite

    Monterrey, Nuevo León 64718
    Mexico

    Site Not Available

  • Eukarya PharmaSite

    Monterrey 3995465, Nuevo León 3522542 64718
    Mexico

    Site Not Available

  • Scientia Investigacion Clinica S.C.

    Chihuahua, 31207
    Mexico

    Site Not Available

  • Scientia Investigacion Clinica S.C.

    Chihuahua City 4014338, 31207
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca, 68020
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City 3522507, 68020
    Mexico

    Site Not Available

  • Diamond Clinic

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-559
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warsaw 756135, Masovian Voivodeship 858787 00-874
    Poland

    Site Not Available

  • Centrum Medyczne Evimed

    Warsaw, Mazowieckie 02-625
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa, Mazowieckie 00-874
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warszawa, Mazowieckie 00-874
    Poland

    Site Not Available

  • Diamond Clinic

    Krakow, Małopolskie 31-559
    Poland

    Site Not Available

  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

    Bialystok, Podlaskie 15-375
    Poland

    Site Not Available

  • Specderm Poznanska

    Bialystok, Podlaskie 15-375
    Poland

    Site Not Available

  • Specderm Poznanska

    Bialystok 776069, Podlaskie Voivodeship 858789 15-375
    Poland

    Site Not Available

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

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-546
    Poland

    Site Not Available

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

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

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

    Lodz, Łódzkie 90-265
    Poland

    Site Not Available

  • DERMED Centrum Medyczne Sp. z o.o.

    Lodz, Łódzkie 90-265
    Poland

    Site Not Available

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

    Lodz, Łódzkie 90-436
    Poland

    Site Not Available

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

    Lodz 3093133, Łódź Voivodeship 3337493 90-265
    Poland

    Site Not Available

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

    Lodz 3093133, Łódź Voivodeship 3337493 90-436
    Poland

    Site Not Available

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

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

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-si 1846918, Kyǒnggi-do 15355
    South Korea

    Site Not Available

  • Pusan National University Hospital

    Busan 1838524, Pusan-Kwangyǒkshi 49241
    South Korea

    Site Not Available

  • Chung-Ang University Hospital

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

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul 1835848, Seoul-teukbyeolsi [Seoul] 07441
    South Korea

    Site Not Available

  • National Medical Center

    Seoul 1835848, Seoul-teukbyeolsi [Seoul] 01812
    South Korea

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung 7280289 83301
    Taiwan

    Site Not Available

  • Municipal TuCheng Hospital

    New Taipei City, New Taipei 236
    Taiwan

    Site Not Available

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, New Taipei 236
    Taiwan

    Site Not Available

  • New Taipei Municipal TuCheng Hospital

    New Taipei City 12908892, New Taipei 236
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung 1668399, Taichung 402
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung City, Taichung 402
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei City, Taipei 7280290 114
    Taiwan

    Site Not Available

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300
    Taiwan

    Site Not Available

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu 1675151, 300
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei, 235
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City 12908892, 235
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital-Taipei

    Taipei, 105
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei City, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Arkansas Research Trials

    North Little Rock, Arkansas 72217
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith 4111410, Arkansas 4099753 72916
    United States

    Site Not Available

  • Arkansas Research Trials

    North Little Rock 4124112, Arkansas 4099753 72217
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Encore Medical Research

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • Conquest Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Allergy and Asthma Specialist

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Allergy and Asthma Specialist

    Owensboro 4303436, Kentucky 6254925 42301
    United States

    Site Not Available

  • Revival Research Institute - Troy

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc.

    Portsmouth 5091383, New Hampshire 5090174 03801
    United States

    Site Not Available

  • Metropolitan Dermatology - Clark

    Kenilworth, New Jersey 07033
    United States

    Site Not Available

  • Metropolitan Dermatology - Clark

    Kenilworth 5100007, New Jersey 5101760 07033
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland 5746545, Oregon 5744337 97210
    United States

    Site Not Available

  • DermDox Centers for Dermatology

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • DermDox Centers for Dermatology

    Camp Hill 5182928, Pennsylvania 6254927 17011
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Center for Clinical Studies, LTD.LLP

    Webster, Texas 77598
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio 4726206, Texas 4736286 78213
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster 4740423, Texas 4736286 77598
    United States

    Site Not Available

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