A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

NCT ID: NCT05601882

Last Updated: 2025-02-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-08-08

Brief Summary

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Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dupilumab (Period 1)

Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16.

Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16.

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Dupilumab is administered as a subcutaneous (SC) injection.

Upadacitinib (Period 1)

Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response.

Group Type EXPERIMENTAL

Upadacitinib

Intervention Type DRUG

Extended-release tablet

Dupilumab -> Upadacitinib (Period 2)

At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32.

Group Type EXPERIMENTAL

Upadacitinib

Intervention Type DRUG

Extended-release tablet

Upadacitinib -> Upadacitinib 30 mg (Period 2)

At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures.

Group Type EXPERIMENTAL

Upadacitinib

Intervention Type DRUG

Extended-release tablet

Interventions

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Dupilumab

Dupilumab is administered as a subcutaneous (SC) injection.

Intervention Type DRUG

Upadacitinib

Extended-release tablet

Intervention Type DRUG

Other Intervention Names

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Dupixent® ABT-494 RINVOQ

Eligibility Criteria

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Inclusion Criteria

* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
* Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
* Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.
* Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclusion Criteria

* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* History of an organ transplant which requires continued immunosuppression.
Minimum Eligible Age

12 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Medical Dermatology Specialists /ID# 250212

Phoenix, Arizona, United States

Site Status

Alliance Dermatology and Mohs Center /ID# 249671

Phoenix, Arizona, United States

Site Status

Clinical Trials Institute - Northwest Arkansas /ID# 249838

Fayetteville, Arkansas, United States

Site Status

Arkansas Research Trials /ID# 250722

North Little Rock, Arkansas, United States

Site Status

Joseph Raoof Md,Inc /Id# 250211

Encino, California, United States

Site Status

First OC Dermatology /ID# 250686

Fountain Valley, California, United States

Site Status

Antelope Valley Clinical Trials /ID# 249946

Lancaster, California, United States

Site Status

Dermatology Research Associates /ID# 249829

Los Angeles, California, United States

Site Status

University of California Davis Health /ID# 250044

Sacramento, California, United States

Site Status

Clinical Trials Research Institute /ID# 250213

Thousand Oaks, California, United States

Site Status

Western States Clinical Res /ID# 250274

Wheat Ridge, Colorado, United States

Site Status

UConn Health /ID# 253807

Farmington, Connecticut, United States

Site Status

Yale Center for Clinical Investigation /ID# 254791

New Haven, Connecticut, United States

Site Status

Clearlyderm Dermatology /ID# 250457

Boca Raton, Florida, United States

Site Status

Skin Care Research Boca Raton /ID# 250458

Boca Raton, Florida, United States

Site Status

Olympian Clinical Research /ID# 250453

Clearwater, Florida, United States

Site Status

Skin Care Research - Hollywood /ID# 250459

Hollywood, Florida, United States

Site Status

Solutions Through Adv Rch /ID# 250455

Jacksonville, Florida, United States

Site Status

GSI Clinical Research, LLC /ID# 250768

Margate, Florida, United States

Site Status

D&H National Research Centers /ID# 250734

Miami, Florida, United States

Site Status

Florida International Rsrch cr /ID# 249667

Miami, Florida, United States

Site Status

Wellness Clinical Research - Miami Lakes /ID# 250236

Miami Lakes, Florida, United States

Site Status

Tory P Sullivan, MD PA /ID# 251136

North Miami Beach, Florida, United States

Site Status

Precision Clinical Research /ID# 250990

Sunrise, Florida, United States

Site Status

Advanced Clinical Research Institute /ID# 250460

Tampa, Florida, United States

Site Status

Metabolic Research Inst /ID# 250046

West Palm Beach, Florida, United States

Site Status

Treasure Valley Medical Research /ID# 250727

Boise, Idaho, United States

Site Status

Dawes Fretzin, LLC /ID# 250276

Indianapolis, Indiana, United States

Site Status

Randall Dermatology of West Lafayette /ID# 250234

West Lafayette, Indiana, United States

Site Status

Beth Israel Deaconess Medical Center /ID# 251212

Boston, Massachusetts, United States

Site Status

Beacon Clinical Research, LLC /ID# 251412

Quincy, Massachusetts, United States

Site Status

Clarkston Dermatology /ID# 250225

Clarkston, Michigan, United States

Site Status

Henry Ford Medical Center - New Center One /ID# 250228

Detroit, Michigan, United States

Site Status

Cleaver Dermatology /ID# 250725

Kirksville, Missouri, United States

Site Status

MediSearch Clinical Trials /ID# 250272

Saint Joseph, Missouri, United States

Site Status

Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616

Lincoln, Nebraska, United States

Site Status

Physician Research Collaboration, LLC /ID# 251099

Lincoln, Nebraska, United States

Site Status

Montefiore Medical Center - Moses Campus /ID# 251214

The Bronx, New York, United States

Site Status

Derm of Greater Columbus /ID# 250049

Bexley, Ohio, United States

Site Status

Univ Hosp Cleveland /ID# 250699

Cleveland, Ohio, United States

Site Status

Wright State Physicians - Fairborn /ID# 254167

Fairborn, Ohio, United States

Site Status

Vital Prospects Clinical Research Institute, PC /ID# 249840

Tulsa, Oklahoma, United States

Site Status

Oregon Dermatology and Research Center /ID# 250726

Portland, Oregon, United States

Site Status

Oregon Medical Research Center /ID# 249666

Portland, Oregon, United States

Site Status

Oregon Medical Research Center /ID# 250712

Portland, Oregon, United States

Site Status

University of Pittsburgh MC /ID# 251208

Pittsburgh, Pennsylvania, United States

Site Status

Duplicate_Medical University of South Carolina /ID# 251218

Charleston, South Carolina, United States

Site Status

Health Concepts /ID# 250988

Rapid City, South Dakota, United States

Site Status

International Clinical Research - Tennessee LLC /ID# 250724

Murfreesboro, Tennessee, United States

Site Status

Arlington Research Center, Inc /ID# 250468

Arlington, Texas, United States

Site Status

Orion Clinical Research /ID# 250473

Austin, Texas, United States

Site Status

Bellaire Dermatology Associates /ID# 250739

Bellaire, Texas, United States

Site Status

Modern Research Associates, PLLC /ID# 250688

Dallas, Texas, United States

Site Status

Center for Clinical Studies - Houston - Northwest Freeway /ID# 250039

Houston, Texas, United States

Site Status

Texas Dermatology and Laser Specialists /ID# 250367

San Antonio, Texas, United States

Site Status

University of Utah /ID# 250042

Murray, Utah, United States

Site Status

University of Virginia - Dermatology /ID# 254166

Charlottesville, Virginia, United States

Site Status

Virginia Clinical Research, Inc. /ID# 249908

Norfolk, Virginia, United States

Site Status

Premier Specialist /ID# 250572

Kogarah, New South Wales, Australia

Site Status

Veracity Clinical Research /ID# 249943

Woolloongabba, Queensland, Australia

Site Status

Skin Health Institute Inc /ID# 249938

Carlton, Victoria, Australia

Site Status

Sinclair Dermatology - Melbourne /ID# 249937

East Melbourne, Victoria, Australia

Site Status

Fremantle Dermatology /ID# 249941

Fremantle, Western Australia, Australia

Site Status

Cliniques Universitaires UCL Saint-Luc /ID# 251403

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status

Grand Hopital de Charleroi /ID# 251401

Charleroi, Hainaut, Belgium

Site Status

Universitair Ziekenhuis Leuven /ID# 251399

Leuven, Vlaams-Brabant, Belgium

Site Status

CHU de Liege /ID# 251400

Liège, , Belgium

Site Status

UMHAT Dr Georgi Stranski EAD /ID# 251268

Pleven, Smolyan, Bulgaria

Site Status

Diagnostic Consultative Center Aleksandrovska /ID# 251137

Sofiya, Sofia, Bulgaria

Site Status

DCC Pulmed AD /ID# 251271

Plovdiv, , Bulgaria

Site Status

Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 251272

Sofia, , Bulgaria

Site Status

Diagnostic consultative center Focus-5 /ID# 251269

Sofia, , Bulgaria

Site Status

Medical Center Euroderma /ID# 251267

Sofia, , Bulgaria

Site Status

Medical center EuroHealth /ID# 251270

Sofia, , Bulgaria

Site Status

Military Medical Academy Multiprofile Hospital /ID# 251187

Sofia, , Bulgaria

Site Status

MC Zara-Med EOOD /ID# 251135

Stara Zagora, , Bulgaria

Site Status

Dermatology Research Institute - Blackfoot Trail /ID# 251642

Calgary, Alberta, Canada

Site Status

Beacon Dermatology Inc /ID# 250336

Calgary, Alberta, Canada

Site Status

Alberta DermaSurgery Centre /ID# 250217

Edmonton, Alberta, Canada

Site Status

Dr. Chih-ho Hong Medical Inc. /ID# 251643

Surrey, British Columbia, Canada

Site Status

Enverus Medical Research /ID# 251645

Surrey, British Columbia, Canada

Site Status

Wiseman Dermatology Research /ID# 250219

Winnipeg, Manitoba, Canada

Site Status

Brunswick Dermatology Center /ID# 250220

Fredericton, New Brunswick, Canada

Site Status

LEADER Research /ID# 251647

Hamilton, Ontario, Canada

Site Status

DermEffects /ID# 250223

London, Ontario, Canada

Site Status

Lynde Institute for Dermatology /ID# 251854

Markham, Ontario, Canada

Site Status

DermEdge Research Inc. /ID# 250216

Mississauga, Ontario, Canada

Site Status

SKiN Centre for Dermatology /ID# 251853

Peterborough, Ontario, Canada

Site Status

Toronto Dermatology Centre /ID# 252098

Toronto, Ontario, Canada

Site Status

Research Toronto /ID# 250222

Toronto, Ontario, Canada

Site Status

Private Practice - Dr. Kim Papp Clinical Research /ID# 251644

Waterloo, Ontario, Canada

Site Status

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 250427

Québec, Quebec, Canada

Site Status

The First Affiliated Hospital Of Fujian Medical University /ID# 249674

Fuzhou, Fujian, China

Site Status

Dermatology Hospital of Southern Medical University /ID# 250121

Guangzhou, Guangdong, China

Site Status

Guangzhou First People's Hospital /ID# 249695

Guangzhou, Guangdong, China

Site Status

The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694

Guangzhou, Guangdong, China

Site Status

The University of Hong Kong- Shenzhen Hospital /ID# 249436

Shenzhen, Guangdong, China

Site Status

The Second Xiangya Hospital of Central South University /ID# 249657

Changsha, Guizhou, China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485

Wuhan, Hubei, China

Site Status

The First Hospital of China Medical University /ID# 249638

Shenyang, Liaoning, China

Site Status

Huashan Hospital, Fudan University /ID# 250025

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Skin Disease Hospital /ID# 249392

Shanghai, Shanghai Municipality, China

Site Status

Tianjin Medical University General Hospital /ID# 250246

Tianjin, Tianjin Municipality, China

Site Status

Hangzhou First People's Hospital /ID# 249437

Hangzhou, Zhejiang, China

Site Status

The second affiliated hospital of Zhejiang University school of medicine /ID# 249655

Hangzhou, Zhejiang, China

Site Status

Zhejiang Provincial People's Hospital /ID# 249653

Hangzhou, Zhejiang, China

Site Status

Poliklinika Solmed /ID# 252138

Grad Zagreb, City of Zagreb, Croatia

Site Status

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 249591

Zagreb, City of Zagreb, Croatia

Site Status

Djecja bolnica Srebrnjak /ID# 249594

Zagreb, City of Zagreb, Croatia

Site Status

Klinicki bolnicki centar Zagreb /ID# 249596

Zagreb, City of Zagreb, Croatia

Site Status

Klinika za dječje bolesti Zagreb /ID# 249590

Zagreb, City of Zagreb, Croatia

Site Status

Klinicki bolnicki centar Rijeka /ID# 249593

Rijeka, Primorje-Gorski Kotar County, Croatia

Site Status

Klinicki Bolnicki Centar (KBC) Split /ID# 249879

Split, Split-Dalmatia County, Croatia

Site Status

Bispebjerg and Frederiksberg Hospital /ID# 248902

Copenhagen NV, Capital Region, Denmark

Site Status

Herlev and Gentofte Hospital /ID# 248900

Hellerup, Capital Region, Denmark

Site Status

Aarhus Universitetshospital - Skejby /ID# 248899

Aarhus, Central Jutland, Denmark

Site Status

Roskilde Sygehus /ID# 248901

Roskilde, Region Sjælland, Denmark

Site Status

Hopital Saint Joseph /ID# 251053

Marseille, Bouches-du-Rhone, France

Site Status

CHU de Nantes, Hotel Dieu -HME /ID# 251347

Nantes, Pays de la Loire Region, France

Site Status

HCL - Hopital Lyon Sud /ID# 251343

Pierre-Bénite, Rhone, France

Site Status

Hôpital Saint-Louis /ID# 251052

Paris, , France

Site Status

Hôpital Charles-Nicolle /ID# 251055

Rouen, , France

Site Status

CHU Toulouse - Hopital Larrey /ID# 251344

Toulouse, , France

Site Status

Universitaetsklinikum Freiburg /ID# 249555

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinik Heidelberg /ID# 251458

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Universitaetsklinikum Tuebingen /ID# 249552

Tübingen, Baden-Wurttemberg, Germany

Site Status

Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306

Blankenfelde-Mahlow, Brandenburg, Germany

Site Status

Klinikum Darmstadt /ID# 251391

Darmstadt, Hesse, Germany

Site Status

Universitaetsklinikum Frankfurt /ID# 249544

Frankfurt am Main, Hesse, Germany

Site Status

Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 251392

Bramsche, Lower Saxony, Germany

Site Status

Universitaetsklinikum Bonn /ID# 250307

Bonn, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Muenster /ID# 249404

Münster, North Rhine-Westphalia, Germany

Site Status

Universitaetsmedizin Mainz /ID# 249549

Mainz, Rhineland-Palatinate, Germany

Site Status

Fachklinik Bad Bentheim /ID# 249545

Bad Bentheim, Saarland, Germany

Site Status

Universitaetsklinikum Leipzig /ID# 249562

Leipzig, Saxony, Germany

Site Status

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560

Lübeck, Schleswig-Holstein, Germany

Site Status

Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 251566

Bochum, , Germany

Site Status

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 251844

Dresden, , Germany

Site Status

Derma Study Center Friedrichshafen GmbH /ID# 251460

Friedrichshafen, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf /ID# 249547

Hamburg, , Germany

Site Status

Dermatologikum Hamburg /ID# 251390

Hamburg, , Germany

Site Status

Klinikum rechts der Isar /ID# 249548

Munich, , Germany

Site Status

401 GSNA - 401 Army General Hospital /ID# 251843

Athens, Attica, Greece

Site Status

General Hospital Andreas Syggros /ID# 251842

Athens, Attica, Greece

Site Status

Papageorgiou General Hospital /ID# 251840

Thessaloniki, Evrytania, Greece

Site Status

Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 249850

Kecskemét, Bács-Kiskun county, Hungary

Site Status

Debreceni Egyetem-Klinikai Kozpont /ID# 249849

Debrecen, Hajdú-Bihar, Hungary

Site Status

Gyongyosi Bugat Pal Korhaz /ID# 251367

Gyöngyös, Heves County, Hungary

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419

Pecs, Nógrád megye, Hungary

Site Status

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 249848

Kaposvár, Somogy County, Hungary

Site Status

Clinexpert Kft /ID# 249822

Budapest, , Hungary

Site Status

Semmelweis Egyetem /ID# 251368

Budapest, , Hungary

Site Status

UNO Medical Trials /ID# 249820

Budapest, , Hungary

Site Status

DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 249819

Debrecen, , Hungary

Site Status

Szegedi Tudományegyetem /ID# 249818

Szeged, , Hungary

Site Status

Allergo-Derm Bakos Kft. /ID# 249821

Szolnok, , Hungary

Site Status

Hadassah Medical Center-Hebrew University /ID# 251576

Jerusalem, Jerusalem, Israel

Site Status

Rabin Medical Center /ID# 251578

Haifa, , Israel

Site Status

CAST - Center for Advanced Studies and Technology /ID# 251495

Chieti, L Aquila, Italy

Site Status

Presidio Ospedaliero San Salvatore /ID# 250127

L’Aquila, L Aquila, Italy

Site Status

IRCCS Istituto Clinico Humanitas /ID# 251493

Rozzano, Milano, Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 250125

Rome, Roma, Italy

Site Status

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558

Rome, Roma, Italy

Site Status

Policlinico Agostino Gemelli /ID# 251494

Rome, Roma, Italy

Site Status

ASST degli Spedali Civili di Brescia /ID# 250129

Brescia, , Italy

Site Status

Ospedale Piero Palagi /ID# 250206

Florence, , Italy

Site Status

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 250123

Milan, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Modena /ID# 250128

Modena, , Italy

Site Status

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 251572

Perugia, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana /ID# 250124

Pisa, , Italy

Site Status

Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 252549

Sapporo, Hokkaido, Japan

Site Status

Medical corporation Kojunkai Kosugi Dermatology Clinic /ID# 252554

Kawasaki-shi, Kanagawa, Japan

Site Status

National Hospital Organization Sagamihara National Hospital /ID# 254518

Sagamihara-shi, Kanagawa, Japan

Site Status

Queen's Square Medical Center, Dermatology and Allergology /ID# 252551

Yokohama, Kanagawa, Japan

Site Status

Osaka Habikino Medical Center /ID# 252550

Habikino-shi, Osaka, Japan

Site Status

Dermatology and Ophthalmology Kume Clinic /ID# 254570

Sakai-shi, Osaka, Japan

Site Status

Naoko Dermatology Clinic /ID# 254571

Setagaya-ku, Tokyo, Japan

Site Status

Centro de Dermatologia de Monterrey /ID# 249126

Monterrey, Estado de Baja California, Mexico

Site Status

Eukarya PharmaSite, SC /ID# 249702

Monterrey, Nuevo León, Mexico

Site Status

Cryptex Investigacion Clinica S.A de C.V /ID# 249994

Mexico City, , Mexico

Site Status

Clinical Research Institute SC /ID# 249647

Tlalnepantla, , Mexico

Site Status

Arké Estudios Clinicos Veracruz /ID# 250147

Veracruz, , Mexico

Site Status

Bravis Ziekenhuis /ID# 251395

Bergen op Zoom, North Brabant, Netherlands

Site Status

Amsterdam UMC, locatie AMC /ID# 251397

Amsterdam, North Holland, Netherlands

Site Status

Solumed Centrum Medyczne /ID# 249641

Poznan, Greater Poland Voivodeship, Poland

Site Status

MICS Centrum Medyczne Torun /ID# 251433

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny /ID# 252082

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 251437

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Klinika Ambroziak Sp. z o.o. /ID# 249406

Warsaw, Masovian Voivodeship, Poland

Site Status

Royalderm Agnieszka Nawrocka /ID# 251432

Warsaw, Masovian Voivodeship, Poland

Site Status

Bodyclinic Sp. z o.o. sp.k. /ID# 249599

Warsaw, Masovian Voivodeship, Poland

Site Status

Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o /ID# 249598

Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland

Site Status

INTER CLINIC Piotr Adrian Klimiuk /ID# 251430

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 251438

Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630

Krakow, , Poland

Site Status

Dermed Centrum Medyczne Sp. z o.o /ID# 251429

Lodz, Łódź Voivodeship, Poland

Site Status

Centro Hospitalar Do Alto Ave - Hospital Senhora Da Oliveira /ID# 249196

Guimarães, Braga District, Portugal

Site Status

Hospital CUF Descobertas /ID# 249193

Lisboa, Madeira, Portugal

Site Status

Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191

Porto, Madeira, Portugal

Site Status

Hospital Garcia de Orta /ID# 251455

Almada, Setúbal District, Portugal

Site Status

2CA-Braga, Hospital de Braga /ID# 250480

Braga, , Portugal

Site Status

Unidade Local de Saude da Regiao de Leiria, EPE /ID# 249194

Leiria, , Portugal

Site Status

Centro Hospitalar de Lisboa Central /ID# 249195

Lisbon, , Portugal

Site Status

Unidade Local de Saúde de Matosinhos, EPE /ID# 249197

Matosinhos Municipality, , Portugal

Site Status

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192

Porto, , Portugal

Site Status

Dr. Samuel Sanchez PSC /ID# 250389

Caguas, , Puerto Rico

Site Status

Alma M. Cruz Santana, MD-Private practice /ID# 250393

Carolina, , Puerto Rico

Site Status

Clinical Research Puerto Rico /ID# 250394

San Juan, , Puerto Rico

Site Status

GCM Medical Group PSC /ID# 250391

San Juan, , Puerto Rico

Site Status

Bio Terra Med SRL /ID# 249624

Bucharest, București, Romania

Site Status

Private Practice - Dr. Orasan Remus /ID# 249625

Cluj-Napoca, Cluj, Romania

Site Status

Derma therapy spol /ID# 249783

Bratislava, Bratislava Region, Slovakia

Site Status

Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746

Bratislava, , Slovakia

Site Status

BeneDerma s.r.o. /ID# 251791

Bratislava, , Slovakia

Site Status

University of Pretoria /ID# 250208

Pretoria, Gauteng, South Africa

Site Status

About Allergy /ID# 249697

Pretoria, Gauteng, South Africa

Site Status

Highway Medical Centre /ID# 250103

Durban, KwaZulu-Natal, South Africa

Site Status

Allergy & Immunology (AIU) /ID# 249619

Cape Town, Western Cape, South Africa

Site Status

Spoke Research Inc /ID# 250091

CAPE TOWN Milnerton, Western Cape, South Africa

Site Status

Pusan National University Hospital /ID# 249852

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Kyungpook National University Hospital /ID# 249855

Junggu, Daegu Gwang Yeogsi, South Korea

Site Status

Korea University Ansan Hospital /ID# 249814

Ansan-si, Gyeonggido, South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon /ID# 249812

Bucheon-si, Gyeonggido, South Korea

Site Status

Chungang University Hospital /ID# 251490

Dongjak-gu, Gyeonggido, South Korea

Site Status

Ajou University Hospital /ID# 251491

Suwon, Gyeonggido, South Korea

Site Status

Seoul National University Hospital /ID# 251492

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Konkuk University Medical Center /ID# 249811

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Hospital Universitario Germans Trias i Pujol /ID# 251523

Badalona, Barcelona, Spain

Site Status

Hospital Sant Joan de Deu /ID# 249602

Esplugues de Llobregat, Barcelona, Spain

Site Status

Hospital Universitario Basurto /ID# 249784

Bilbao, Vizcaya, Spain

Site Status

Hospital General Universitario de Alicante Doctor Balmis /ID# 251517

Alicante, , Spain

Site Status

Hospital Universitario Virgen de las Nieves /ID# 249785

Granada, , Spain

Site Status

Hospital Universitario La Paz /ID# 251518

Madrid, , Spain

Site Status

Hospital Universitario Virgen Macarena /ID# 249603

Seville, , Spain

Site Status

Hospital Universitario y Politecnico La Fe /ID# 251524

Valencia, , Spain

Site Status

Skane University hospital /ID# 250332

Malmo, Skåne County, Sweden

Site Status

Karolinska University Hospital Solna /ID# 250328

Solna, Stockholm County, Sweden

Site Status

Norrlands University hospital /ID# 250329

Umeå, Västerbotten County, Sweden

Site Status

Malarsjukhuset /ID# 251908

Eskilstuna, , Sweden

Site Status

Kantonsspital St. Gallen /ID# 250606

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Inselspital, Universitaetsspital Bern /ID# 250577

Bern, , Switzerland

Site Status

Kaohsiung Chang Gung Memorial Hospital /ID# 249260

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Taichung Veterans General Hospital /ID# 249261

Taichung, Keelung, Taiwan

Site Status

National Taiwan University Hospital /ID# 249258

Taipei City, Taipei, Taiwan

Site Status

National Taiwan University Hospital - Hsinchu branch /ID# 249265

Hsinchu, , Taiwan

Site Status

Taipei Medical University Shuang Ho Hospital /ID# 249256

New Taipei City, , Taiwan

Site Status

Mackay Memorial Hospital /ID# 249259

Taipei, , Taiwan

Site Status

Taipei Veterans General Hosp /ID# 249263

Taipei, , Taiwan

Site Status

Taipei Municipal Wan Fang Hospital /ID# 251500

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital /ID# 249257

Taoyuan, , Taiwan

Site Status

Gaziantep Universitesi /ID# 249868

Gaziantep, Adana, Turkey (Türkiye)

Site Status

Ankara City Hospital /ID# 249870

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz Universitesi Tip Fakul /ID# 249866

Antalya, , Turkey (Türkiye)

Site Status

Uludag University Medical Faculty /ID# 249864

Bursa, , Turkey (Türkiye)

Site Status

Erciyes University Medical Faculty /ID# 249863

Kayseri, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Universitesi /ID# 249865

Samsun, , Turkey (Türkiye)

Site Status

Countries

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United States Australia Belgium Bulgaria Canada China Croatia Denmark France Germany Greece Hungary Israel Italy Japan Mexico Netherlands Poland Portugal Puerto Rico Romania Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2022-002482-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M23-696

Identifier Type: -

Identifier Source: org_study_id

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