Clinical trial NCT07020351: A Master Protocol of Multiple Interventions for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis.
Official title: A Master Protocol for Randomized, Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Number of Participants Allocated to FR01 ISA
timeFrame: Screening to Randomization (Up to 90 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Owensboro
country: United States
facility: Allergy and Asthma Specialist
state: Kentucky
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Kenilworth
country: United States
facility: Metropolitan Dermatology - Clark
state: New Jersey
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Camp Hill
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Calgary
country: Canada
facility: Rejuvenation Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Allergy
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jász-Nagykun-Szolnok
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
state: Vas
city: Veszprém
country: Hungary
facility: Medmare Bt
state: Veszprém City
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Chikushino-city
country: Japan
facility: Yasumoto Dermatology Clinic
state: Fukuoka
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Yokohama-city
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Tachikawa
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Trials in Medicine
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Atención en Enfermedades Inflamatorias CATEI
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Bialystok
country: Poland
facility: Specderm Poznanska
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Lodz
country: Poland
facility: "DERMED" Centrum Medyczne Sp. z o.o.
state: Łódzkie
city: Lodz
country: Poland
facility: Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
state: Łódzkie
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital
state: New Taipei
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: