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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05724199
Other study ID # 20210144
Secondary ID 2022-501585-22
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 21, 2023
Est. completion date January 6, 2025

Study information

Verified date April 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The coprimary objectives of the study are to: - evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). - evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 746
Est. completion date January 6, 2025
Est. primary completion date September 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age = 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months - History of inadequate response to TCS of medium or higher potency (with or without TCI) - EASI score =16 - vIGA-AD score =3 - =10% body surface area (BSA) of AD involvement - Worst pruritus numerical rating scale = 4 Exclusion Criteria: - Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 - Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: - Systemic corticosteroids - Nonbiologic, non-targeted Systemic immunosuppressants - Phototherapy - Janus kinase inhibitors - Treatment with any of the following medications or therapies within 1 week, prior to Day 1: - TCS - TCI - Topical phosphodiesterase type 4 inhibitors - Other topical immunosuppressive agents - Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rocatinlimab
Subcutaneous (SC) injection
Other:
Placebo
SC injection

Locations

Country Name City State
Argentina Cinme - Centro de Investigaciones Metabolicas Caba Buenos Aires
Argentina Buenos Aires Skin SA Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Care- Centro de Alergia y Enfermedades Respiratorias Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Fundacion Cidea Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Psoriahue Medicina Interdisciplinaria SRL Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Framingham Centro Medico La Plata Buenos Aires
Argentina Dim Clinica Privada Ramos Mejia Buenos Aires
Argentina Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario Rosario Santa Fe
Australia The Skin Centre Benowa Queensland
Australia Emeritus Research Sydney Botany New South Wales
Australia Emeritus Research Melbourne Camberwell Victoria
Australia Princess Alexandra Hospital South Brisbane Queensland
Australia Westmead Hospital Westmead New South Wales
Australia Veracity Clinical Research Woolloongabba Queensland
Austria Medizinische Universitaet Graz Graz
Austria Medizinische Universitaet Innsbruck Innsbruck
Austria Landeskrankenhaus Salzburg Salzburg
Austria Klinik Hietzing Wien
Austria Klinik Landstrasse Wien
Belgium Algemeen Ziekenhuis Sint-Jan Brugge-Oostende Brugge
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Centre Hospitalier Universitaire Brugmann Brussels
Belgium Universite Catholique de Louvain Cliniques Universitaires Saint Luc Bruxelles
Belgium Universitair Ziekenhuis Gent Gent
Belgium Clinique Andre Renard Herstal
Belgium Dermatologie Handelskaai Kortrijk
Belgium Universitaire Ziekenhuizen Leuven Gasthuisberg Leuven
Belgium Centre Hospitalier Universitaire de Liege - Sart Tilman Liege
Belgium Grand Hopital de Charleroi Loverval
Bulgaria Medical Center Asklepii OOD Dupnitsa
Bulgaria Medical Center Medconsult Pleven OOD Pleven
Bulgaria Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD Sofia
Bulgaria Diagnostic-Consultative Center Alexandrovska EOOD Sofia
Bulgaria Medical Center Excelsior OOD Sofia
Canada Dermatology Research Institute Incorporated Calgary Alberta
Canada SKiN Health Coburg Ontario
Canada Alberta Derma Surgery Centre Edmonton Alberta
Canada Laser Rejuvenation Clinics Edmonton D T Incorporated Edmonton Alberta
Canada Centricity Research London London Ontario
Canada Clinique de Dermatologie Rosemont Montreal Quebec
Canada Innovaderm Research Inc Montreal Quebec
Canada Dr SK Siddha Medicine Professional Corporation Newmarket Ontario
Canada Allergy Research Canada Incorporated Niagara Falls Ontario
Canada North Bay Dermatology Centre North Bay Ontario
Canada Dermatology Ottawa Research Centre Ottawa Ontario
Canada JRB Research Incorporated Ottawa Ontario
Canada Centre de Recherche Saint-Louis Quebec
Canada DIEX Recherche Quebec Quebec
Canada The Centre for Dermatology Richmond Hill Ontario
Canada Saskatoon Dermatology Centre Saskatoon Saskatchewan
Canada Enverus Medical Research Surrey British Columbia
Canada North York Research Incorporated Toronto Ontario
Canada Toronto Research Centre Inc Toronto Ontario
Canada Alliance Clinical Trials Waterloo Ontario
Canada Wiseman Dermatology Research Incorporated Winnipeg Manitoba
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Peking University Peoples Hospital Beijing
China Peking University Third Hospital Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China Chengdu Second Peoples Hospital Chengdu Sichuan
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Dermatology Hospital of Southern Medical University Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong
China The First Affiliated Hospital ,Sun-Yat Sen University Guangzhou Guangdong
China Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang
China Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine Hangzhou Zhejiang
China the First Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Dermatology Hospital of Jiangxi Province Nanchang Jiangxi
China Nanyang First Peoples Hospital Nanyang Henan
China The First Affiliation Hospital Of Ningbo University Ningbo Zhejiang
China Shanghai Skin Disease Hospital Shanghai
China The Fist Affiliated Hospital of Shantou University Medical College Shantou Guangdong
China Shenzhen Qianhai Shekou Free Trade Zone Hospital Shenzhen Guangdong
China Taizhou Central Hospital Taizhou Zhejiang
China Union Hospital Tongji Medical College Huazhong University of science and Technology Wuhan Hubei
China Wuxi Second Peoples Hospital Wuxi Jiangsu
France Hopital Prive d Antony Antony
France Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André Bordeaux
France Centre Hospitalier Regional Universitaire Brest Hopital Morvan Brest
France Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille
France Centre Hospitalier de Bretagne Sud - Hopital du Scorff Lorient Cedex
France Hôpital La Timone Marseille cedex 05
France Cabinet du Docteur Ruer-Mulard Mireille Martigues
France Centre Hospitalier Universitaire de Nantes Hôtel Dieu Nantes
France Centre Hospitalier Universitaire Archet 2 Nice
France Hopital Bichat Claude Bernard Paris
France Hopital Tenon Paris
France Hopital Saint Louis Paris Cedex 10
France Polyclinique de Courlancy Reims
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes Cedex 9
France Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle Rouen Cedex
France Centre Hospitalier Universitaire Saint Etienne Hopital Nord Saint Priest en Jarez
France Hopital d instruction des armees sainte anne Toulon
Germany Universitaetsklinikum Frankfurt Frankfurt am Main
Germany Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen
Germany MensingDerma research GmbH Hamburg
Germany TFS Trial Form Support GmbH Hamburg
Germany Hautaerzte Zentrum Hannover Hannover
Germany Medizinische Hochschule Hannover Hannover
Germany Universitaetsmedizin Mainz Mainz
Germany Beldio Research GmbH Memmingen
Germany Hautmedizin Saar Merzing
Germany Klinikum rechts der Isar der TUM Muenchen
Greece 401 General Military Hospital Of Athens Athens
Greece Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens
Greece University General Hospital of Heraklion Heraklion
Greece General Hospital Of Nea Ionia Konstantopouleio Patision Nea Ionia
Greece Geniko Nosokomeio Peiraia Tzaneio Piraeus
Greece Ippokratio General Hospital of Thessaloniki Thessaloniki
Hungary Trial Pharma Kft Bekescsaba
Hungary Clinexpert Kft Budapest
Hungary Csalogany Orvosi Kozpont Budapest
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Gyongyosi Bugat Pal Korhaz Gyongyos
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary DermaMed Research Kft Oroshaza
Hungary Allergo-Derm Bakos Kft Szolnok
Hungary Obudai Egeszsegugyi Centrum Kft Zalaegerszeg
Italy Ospedale Policlinico San Martino IRCCS Genova
Italy Ospedale San Salvatore LAquila
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma
Italy IRCCS Istituto Clinico Humanitas Rozzano MI
Japan Mildix Skin Clinic Adachi-ku Tokyo
Japan Ekihigashi Dermatology Allergy Clinic Fukuoka-shi Fukuoka
Japan JA Shizuoka Kohseiren Enshu Hospital Hamamatsu-shi Shizuoka
Japan Katahira Dermatology Urology Clinic Kagoshima-shi Kagoshima
Japan Kosugi Dermatology Clinic Kawasaki-shi Kanagawa
Japan Jouzan Hihuka Hinyoukika Clinic Kumamoto-shi Kumamoto
Japan Suizenji Dermatology Clinic Kumamoto-shi Kumamoto
Japan Fukui Dermatology Clinic Nagoya-shi Aichi
Japan Yoshioka Dermatology Clinic Neyagawa-shi Osaka
Japan Takagi Dermatological Clinic Branch Obihiro-shi Hokkaido
Japan Medical Corporation Kojinkai Sapporo Skin Clinic Sapporo-shi Hokkaido
Japan Naoko Dermatology Clinic Setagaya-ku Tokyo
Japan NTT Medical Center Tokyo Shinagawa-ku Tokyo
Japan Yamate Dermatology Clinic Shinjuku-ku Tokyo
Japan Nomura Dermatology Clinic Yokohama-shi Kanagawa
Malaysia Hospital Pulau Pinang Georgetown Pinang
Malaysia Hospital Raja Permaisuri Bainun Ipoh Perak
Malaysia Hospital Sultan Ismail Johor Bahru Johor
Malaysia Queen Elizabeth Hospital Kota Kinabalu Sabah
Malaysia Hospital Kuala Lumpur Kuala Lumpur Wilayah Persekutuan
Malaysia Pusat Perubatan Universiti Kebangsaan Malaysia Kuala Lumpur Wilayah Persekutuan
Malaysia University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan
Netherlands Bravis Ziekenhuis Bergen op Zoom
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Poland Dermapolis Medical Dermatology Center dr n med Edyta Gebska Chorzow
Poland GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero Katowice
Poland Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna Krakow
Poland AppleTreeClinics Network Spzoo Lodz
Poland Ip Clinic Sp zoo Lodz
Poland Twoja Przychodnia Scm Szczecin
Poland DermMedica Spzoo Centrum Columbus Wroclaw
Puerto Rico Doctor Samuel Sanchez PSC Caguas
Romania Theramed Healthcare SRL Brasov
Romania Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor Cluj-Napoca
Romania Spitalul Clinic Judetean Mures Targu Mures
Singapore National Skin Centre Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Slovakia Maxderm, sro Bardejov
Slovakia Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto Bratislava
Slovakia Fakultna nemocnica s poliklinikou JA Reimana Presov Presov
Slovakia Sanare spol sro Svidnik
Slovenia Univerzitetni klinicni center Ljubljana Ljubljana
Slovenia Univerzitetni Klinicni Center Maribor Maribor
Spain Hospital Clinic i Provincial de Barcelona Barcelona Cataluña
Spain Hospital Universitario Basurto Bilbao País Vasco
Spain Hospital Universitario 12 de Octubre Madrid
Spain Complexo Hospitalario Universitario de Pontevedra Pontevedra
Spain Hospital General Universitario de Valencia Valencia Comunidad Valenciana
Switzerland Inselspital Bern Bern
Switzerland Hopitaux Universitaires de Geneve Geneve 14
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Switzerland Kantonsspital Sankt Gallen Sankt Gallen
Switzerland Universitaetsspital Zuerich Zuerich
Turkey Ankara Bilkent Sehir Hastanesi Ankara
Turkey Acibadem Altunizade Hastanesi Istanbul
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Istanbul
Turkey Marmara Universitesi Tip Fakultesi Hastanesi Istanbul
Turkey Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Samsun
United Kingdom Royal United Hospitals Bath NHS Foundation Trust Bath
United Kingdom Russells Hall Hospital Dudley
United Kingdom West Middlesex University Hospital Isleworth
United Kingdom The Royal Free Hospital London
United Kingdom Salford Royal Hospital Salford
United Kingdom Accellacare Yorkshire Shipley
United States Albuquerque Clinical Trials Incorporated Albuquerque New Mexico
United States Atlanta Dermatology, Vein and Research Center, PC Alpharetta Georgia
United States University of Michigan Medical Center Ann Arbor Michigan
United States Divine Dermatology and Aesthetics Atlanta Georgia
United States Oakland Hills Dermatology Auburn Hills Michigan
United States US Dermatology Partners Jollyville Austin Texas
United States Kern Research Inc Bakersfield California
United States Bexley Dermatology Research Bexley Ohio
United States The University of Alabama at Birmingham Birmingham Alabama
United States Chear Center LLC Bronx New York
United States DS Research Clarksville Indiana
United States Newco 3A Research LLC El Paso Texas
United States Schweiger Dermatology Group, PC Research Division Hackensack New Jersey
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Sante Clinical Research Kerrville Texas
United States Vivida Dermatology Las Vegas Nevada
United States Dermatology and Skin Cancer Center Leawood Leawood Kansas
United States Somnos Clinical Research Lincoln Nebraska
United States Keck Medicine of University of Southern California Los Angeles California
United States Wallace Medical Group Inc Los Angeles California
United States Velocity Clinical Research Inc Medford Oregon
United States Industrial Medicine Associates Clinical Research Advanced Dermatology Care Monroe Louisiana
United States Virginia Dermatology and Skin Cancer Center Norfolk Virginia
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Arkansas Research Trials, LLC North Little Rock Arkansas
United States Skin Specialists PC Omaha Nebraska
United States Antelope Valley Clinical Trials Palmdale California
United States Paddington Testing Company Inc Philadelphia Pennsylvania
United States Medical Dermatology Specialists Phoenix Arizona
United States Southwest Skin Specialists Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Texas Dermatology Research Center Plano Texas
United States Health Concepts Rapid City South Dakota
United States Aesthetic and Dermatology Center Rockville Maryland
United States Kaiser Permanente South Sacramento Medical Center Sacramento California
United States University of California at Davis Medical Center Sacramento California
United States Acclaim Clinical Research San Diego California
United States Kaiser Permanente Medical Center - Oakland San Francisco California
United States Kaiser Permanente Medical Center - San Francisco San Francisco California
United States Synergy Dermatology San Francisco California
United States NorthShore University HealthSystem Skokie Illinois
United States US Dermatology Partners Sun City West Sun City West Arizona
United States Olympian Clinical Research - Tampa Tampa Florida
United States TrueBlue Clinical Research Tampa Florida
United States Accellacare of Wilmington Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  China,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Malaysia,  Netherlands,  Poland,  Puerto Rico,  Romania,  Singapore,  Slovakia,  Slovenia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achievement of a vIGA-AD Score of 0 or 1 with a =2 Point Reduction From Baseline at Week 24 Baseline, Week 24
Primary Achievement of = 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 Baseline, Week 24
Secondary Achievement of EASI 75 at Week 16 Baseline, Week 16
Secondary Achievement of vIGA-AD 0/1 at Week 16 Baseline, Week 16
Secondary Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4 Baseline, Week 16
Secondary Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4 Baseline, Week 24
Secondary Achievement of = 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 Baseline, Week 24
Secondary Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 4 Baseline, Week 24
Secondary Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24 Baseline, Week 24
Secondary Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline Baseline, Week 24
Secondary Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline Baseline, Week 24
Secondary Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 Baseline, Week 16
Secondary Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 Baseline, Week 24
Secondary Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 Baseline, Week 16
Secondary Change From Baseline in SCORAD Itch VAS Score at Week 24 Baseline, Week 24
Secondary Achievement of = 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score = 4 Baseline, Week 24
Secondary Change from Baseline in DLQI Score at Week 24 Baseline, Week 24
Secondary Achievement of a = 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score = 4 Baseline, Week 24
Secondary Change From Baseline in POEM Score at Week 24 Baseline, Week 24
Secondary Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD skin pain NRS Score = 4 Baseline, Week 16
Secondary Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 Baseline, Week 24
Secondary Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 Baseline, Week 16
Secondary Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3 Baseline, Week 24
Secondary Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3 Baseline, Week 16
Secondary Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 Baseline, Week 24
Secondary Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score = 8 Baseline, Week 24
Secondary Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8 Baseline, Week 24
Secondary Change From Baseline in HADS-anxiety Subscale Score at Week 24 Baseline, Week 24
Secondary Change From Baseline in HADS-depression Subscale Score at Week 24 Baseline, Week 24
Secondary Achievement of a = 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score = 8.7 Baseline, Week 24
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