A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

NCT03738397 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: M16-0462018-002264-57
• Study Type: interventional
• Target: 673
• Locations: 23 countries
• Sites: 159

Brief Summary

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Conditions

Atopic Dermatitis

Keywords

Upadacitinib; ABT-494; Dupilumab; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16

  EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

  Baseline and Week 16

Secondary Outcomes (7)

• Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16

  Baseline (Week 0) to Week 16

• Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16

  Baseline and Week 16

• Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16

  Baseline and Week 16

• Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4

  Baseline (Week 0) to Week 4

• Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2

  Baseline and Week 2

Study Arms (2)

Upadacitinib 30 mg QD

EXPERIMENTAL

Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.

Biological: Upadacitinib; Drug: Placebo to dupilumab

Dupilumab 300 mg EOW

EXPERIMENTAL

Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.

Biological: Dupilumab; Drug: Placebo to upadacitinib

Interventions

Upadacitinib BIOLOGICAL

Extended release tablet

Also known as: ABT-494, RINVOQ®

Upadacitinib 30 mg QD

Dupilumab BIOLOGICAL

Dupilumab is administered as a subcutaneous (SC) injection

Also known as: Dupixent®

Dupilumab 300 mg EOW

Placebo to dupilumab DRUG

Placebo administered as a subcutaneous injection

Upadacitinib 30 mg QD

Placebo to upadacitinib DRUG

Tablet

Dupilumab 300 mg EOW

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
• Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

You may not qualify if:

• Participant has prior exposure to Janus Kinase (JAK) inhibitor.
• Participant has prior exposure to dupilumab.
• Participant is unable or unwilling to discontinue current AD treatments prior to the study.
• Participant has requirement of prohibited medications during the study.
• Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
• Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (159)

Clinical Research Center AL /ID# 210277

Birmingham, Alabama, 35209-6802, United States

Location

University of Arkansas for Medical Sciences /ID# 211688

Little Rock, Arkansas, 72205, United States

Location

Tien Q Nguyen MD, Inc /ID# 208934

Fountain Valley, California, 92708-3701, United States

Location

UCSF Fresno /ID# 213253

Fresno, California, 93701-2302, United States

Location

Jonathan Corren, MD. INC /ID# 208987

Los Angeles, California, 90025-4749, United States

Location

California Allergy and Asthma Medical Group /ID# 213680

Los Angeles, California, 90025-7014, United States

Location

Dermatology Research Associates /ID# 209097

Los Angeles, California, 90045, United States

Location

Los Angelos Cataract Center /ID# 208524

Los Angeles, California, 90056, United States

Location

Dermatology Clinical Trials /ID# 214622

Newport Beach, California, 92660-7853, United States

Location

UC Davis Health /ID# 209285

Sacramento, California, 95816, United States

Location

Ucsd /Id# 208990

San Diego, California, 92103, United States

Location

Clinical Science Institute /ID# 211022

Santa Monica, California, 90404-2102, United States

Location

The Community Research of South Florida /ID# 211145

Hialeah, Florida, 33016-1897, United States

Location

Miami Dermatology and Laser Institute /ID# 212938

Miami, Florida, 33173-3570, United States

Location

Florida International Rsrch cr /ID# 211562

Miami, Florida, 33173, United States

Location

Progressive Medical Research /ID# 211994

Port Orange, Florida, 32127, United States

Location

GCP Research /ID# 216020

St. Petersburg, Florida, 33705, United States

Location

Clinical Research Trials of Florida, Inc. /ID# 210751

Tampa, Florida, 33607, United States

Location

Integrated Clinical Research LLC /ID# 208831

West Palm Beach, Florida, 33406-6063, United States

Location

Georgia Pollens Clinical Research Centers, Inc /ID# 211092

Albany, Georgia, 31707-1282, United States

Location

Meridian Clinical Research Dermatology /ID# 213251

Savannah, Georgia, 31406-2632, United States

Location

Northwestern University Feinberg School of Medicine /ID# 208680

Chicago, Illinois, 60611-2927, United States

Location

Medical Dermatology Associates of Chicago /ID# 210265

Chicago, Illinois, 60654-6903, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058

Normal, Illinois, 61761, United States

Location

Dawes Fretzin, LLC /ID# 209187

Indianapolis, Indiana, 46256, United States

Location

Beacon Clinical Research, LLC /ID# 209280

Quincy, Massachusetts, 02169, United States

Location

Clarkston Skin Research /ID# 208739

Clarkston, Michigan, 48346, United States

Location

Henry Ford Health System /ID# 208741

Detroit, Michigan, 48202, United States

Location

Clinical Research Institute, Inc /ID# 210852

Minneapolis, Minnesota, 55402-2606, United States

Location

Allergy, Asthma & Immunology Associates, PC /ID# 213481

Lincoln, Nebraska, 68505-2343, United States

Location

Skin Specialists, PC /ID# 208843

Omaha, Nebraska, 68144, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 213727

Lebanon, New Hampshire, 03756, United States

Location

Forest Hills Dermatology Group /ID# 209249

Kew Gardens, New York, 11415, United States

Location

Montefiore Medical Center /ID# 209647

The Bronx, New York, 10467, United States

Location

Wake Forest Univ HS /ID# 208892

Winston-Salem, North Carolina, 27157, United States

Location

Univ Hosp Cleveland /ID# 208852

Cleveland, Ohio, 44106, United States

Location

The Ohio State University /ID# 209254

Columbus, Ohio, 43210-1257, United States

Location

Southside Dermatology /ID# 212004

Tulsa, Oklahoma, 74132, United States

Location

Oregon Medical Res Center PC /ID# 208807

Portland, Oregon, 97223, United States

Location

Oregon Health and Science University /ID# 208809

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina /ID# 211054

Charleston, South Carolina, 29425, United States

Location

Clinical Research Solutions, LLC /ID# 212542

Jackson, Tennessee, 38305-2163, United States

Location

Orion Clinical Research /ID# 208765

Austin, Texas, 78759-4100, United States

Location

DiscoveResearch, Inc. /ID# 213171

Bryan, Texas, 77802, United States

Location

Epiphany Dermatology - Fort Worth /ID# 211187

Fort Worth, Texas, 76244-6548, United States

Location

Sante Clinical Research /ID# 212970

Kerrville, Texas, 78028-9640, United States

Location

Stephen Miller, MD PA /ID# 210071

San Antonio, Texas, 78249, United States

Location

Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153

Sugar Land, Texas, 77479-3153, United States

Location

University of Utah /ID# 209001

Salt Lake City, Utah, 84112-5500, United States

Location

Clinical Research Partners, LLC /ID# 212262

Richmond, Virginia, 23220-4459, United States

Location

Premier Clinical Research /ID# 212142

Spokane, Washington, 99202, United States

Location

West Virginia Research Inst /ID# 212730

South Charleston, West Virginia, 25309, United States

Location

Holdsworth House Medical Practice /ID# 214565

Darlinghurst, New South Wales, 2010, Australia

Location

The Skin Hospital /ID# 214401

Darlinghurst, New South Wales, 2010, Australia

Location

Veracity Clinical Research /ID# 211134

Woolloongabba, Queensland, 4102, Australia

Location

Sinclair Dermatology /ID# 209395

East Melbourne, Victoria, 3002, Australia

Location

Burswood Dermatology /ID# 214875

Victoria Park, Western Australia, 6100, Australia

Location

Kirk Barber Research, CA /ID# 209504

Calgary, Alberta, T2G 1B1, Canada

Location

Dermatology Research Institute Inc. /ID# 210942

Calgary, Alberta, T2J 7E1, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 211032

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 209503

Surrey, British Columbia, V3V 0C6, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 211400

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc. /ID# 209505

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research Inc. /ID# 211122

Mississauga, Ontario, L5H 1G9, Canada

Location

Niakosari Medicine Professional Corporation /ID# 211401

Toronto, Ontario, M2M 4J5, Canada

Location

K. Papp Clinical Research /ID# 209509

Waterloo, Ontario, N2J 1C4, Canada

Location

Dre Angelique Gagne-Henley M.D. inc. /ID# 209498

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935

Zagreb, City of Zagreb, 10000, Croatia

Location

Djecja bolnica Srebrnjak /ID# 209939

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 209976

Zagreb, City of Zagreb, 10000, Croatia

Location

Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937

Ivanić-Grad, Zagreb County, 10310, Croatia

Location

Fakultni Nemocnice Brno /ID# 212968

Brno, 625 00, Czechia

Location

FN Hradec Kralove /ID# 209116

Hradec Králové, 500 05, Czechia

Location

Nemocnice Jihlava, prispevkova organizace /ID# 209131

Jihlava, 586 01, Czechia

Location

Fakultni nemocnice Ostrava /ID# 209117

Ostrava, 708 52, Czechia

Location

Fakultni Nemocnice v Motole /ID# 209209

Prague, 150 06, Czechia

Location

Keski-pohjanmaa Central Hospital /ID# 209534

Kokkola, Keski-Pohjanmaa, 67200, Finland

Location

Oulu University Hospital /ID# 208961

Oulu, North Ostrobothnia, 90220, Finland

Location

Mikkeli Central Hospital /ID# 210125

Mikkeli, 50100, Finland

Location

Pihlajalinna Turku /ID# 209599

Turku, 20100, Finland

Location

CHRU Lille - Hopital Claude Huriez /ID# 209317

Lille, Hauts-de-France, 59045, France

Location

CHU de Nantes - Hotel Dieu /ID# 208974

Nantes, Pays de la Loire Region, 44093, France

Location

Charles Nicolle CHU Rouen /ID# 208973

Rouen, Seine-Maritime, 76031, France

Location

Hopital de la Timone /ID# 211245

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374

Nice, 06202, France

Location

Polyclinique Courlancy /ID# 208975

Reims, 51100, France

Location

Hopital Larrey - CHU de Toulouse /ID# 208976

Toulouse, 31059, France

Location

Universitatsklinikum Munster /ID# 210935

Munster, Lower Saxony, 48149, Germany

Location

Gemeinschaftspraxis /ID# 211174

Blankenfeld-mahlow, 15831, Germany

Location

Hautklinik Klinikum Darmstadt /ID# 210938

Darmstadt, 64283, Germany

Location

Universitaetsklinikum Frankfurt /ID# 210934

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover /ID# 210939

Hanover, 30625, Germany

Location

TU Uniklinik Munchen /ID# 210937

Munich, 80802, Germany

Location

Oroshazi Korhaz /ID# 210150

Orosháza, Bekes County, 5900, Hungary

Location

Uno Medical Trials Kft /ID# 211177

Budapest XIII, 1135, Hungary

Location

Debreceni Egyetem Klinikai Kozpont /ID# 210893

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mor Oktat /ID# 210149

Kaposvár, 7400, Hungary

Location

Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892

Pécs, 7624, Hungary

Location

St Vincent's University Hosp /ID# 208441

Dublin, D04 T6F4, Ireland

Location

University Hospital Waterford /ID# 208442

Waterford, X91 ER8E, Ireland

Location

HaEmek Medical Center /ID# 210153

Afula, 1834111, Israel

Location

Rabin Medical Center /ID# 210012

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center /ID# 210013

Ramat Gan, 5239424, Israel

Location

Ichilov Medical Center /ID# 210014

Tel Aviv, 64239, Israel

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632

Milan, Lombardy, 20122, Italy

Location

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726

Rozzano, Milano, 20089, Italy

Location

A.O. Policlinico Sant'Orsola Malpighi /ID# 209111

Bologna, 40138, Italy

Location

A.O.U. di Brescia /ID# 209115

Brescia, 25123, Italy

Location

Ospedale San Giovanni di Dio /ID# 209109

Cagliari, 9124, Italy

Location

AO Univ di Modena /ID# 209110

Modena, 41100, Italy

Location

Policlinico Univ Tor Vergata /ID# 209112

Rome, 00133, Italy

Location

Hospital Sultan Ismail /ID# 211037

Johor Bahru, Johor, 81100, Malaysia

Location

Hospital Pakar Sultanah Fatimah /ID# 210185

Muar town, Johor, 84000, Malaysia

Location

UKM Medical Centre /ID# 209178

Kuala Lumpur, Selangor, 56000, Malaysia

Location

Hospital Pulau Pinang /ID# 210212

George Town, 10450, Malaysia

Location

University Malaya Med Ctr /ID# 208861

Kuala Lumpur, 59100, Malaysia

Location

Hospital Putrajaya /ID# 209177

Putrajaya, 62250, Malaysia

Location

Bravis Ziekenhuis /ID# 208584

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Academisch Medisch Centrum /ID# 208578

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Centrum Oosterwal /ID# 209641

Alkmaar, 1817 MS, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 208583

Groningen, 9713 GZ, Netherlands

Location

Erasmus Medisch Centrum /ID# 208582

Rotterdam, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 208579

Utrecht, 3584 CX, Netherlands

Location

Optimal Clinical Trials Ltd /ID# 209475

Auckland, 1010, New Zealand

Location

Clinical Trials NZ /ID# 215590

Hamilton, 3206, New Zealand

Location

Wellington Hospital (Capital and Coast District Health Board) /ID# 215001

Wellington, 6021, New Zealand

Location

St. Olavs Hospital HF /ID# 209137

Trondheim, Sor-Trondelag, 7006, Norway

Location

Universitetssykehuset N-Norge, Harstad /ID# 209105

Harstad, Troms, 9406, Norway

Location

Universitetssykehuset N-Norge, Tromso /ID# 209103

Tromsø, Troms, 9019, Norway

Location

Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

Pratia MCM Krakow /ID# 207444

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Klinika Ambroziak Sp. z o.o. /ID# 207443

Warsaw, Masovian Voivodeship, 02-758, Poland

Location

Royalderm Agnieszka Nawrocka /ID# 211015

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

ClinicMed Daniluk, Nowak Sp.j. /ID# 211112

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Dermoklinika Medical Center /ID# 211026

Lodz, Łódź Voivodeship, 90-436, Poland

Location

National Skin Centre /ID# 208775

Singapore, Central Singapore, 308205, Singapore

Location

National University Hospital /ID# 208774

Singapore, 119074, Singapore

Location

Singapore General Hospital /ID# 208776

Singapore, 169608, Singapore

Location

Hospital Universitario de Bellvitge /ID# 207063

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Dr. Negrin /ID# 208969

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital de Manises /ID# 207062

Manises, Valencia, 46940, Spain

Location

Complejo Hospitalario Universitario de Pontevedra /ID# 207139

Pontevedra, 36071, Spain

Location

Hospital Universitario Arnau Vilanova /ID# 207065

Valencia, 46015, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 207064

Valencia, 46026, Spain

Location

Skanes Universitetssjukhus /ID# 206783

Malmo, Skåne County, 214 28, Sweden

Location

Karolinska University Hospital /ID# 207909

Stockholm, SE-17176, Sweden

Location

China Medical University Hosp /ID# 209770

Taichung, Taichung, 40447, Taiwan

Location

National Taiwan University Hospital /ID# 208309

Taipei City, Taipei, 100, Taiwan

Location

Chung Shan Medical University /ID# 208311

Taichung, 40201, Taiwan

Location

Taipei Municipal Wan Fang Hospital /ID# 209987

Taipei, 116, Taiwan

Location

Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435

Zaporizhzhya, Zaporizhzhia Oblast, 69063, Ukraine

Location

Kyiv City Clinical Skin and Venereal Hospital /ID# 210755

Kyiv, 04209, Ukraine

Location

ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434

Rivne, 33028, Ukraine

Location

Royal Alex Childrens County Hospital /ID# 209709

Brighton, Brighton And Hove, BN2 5BE, United Kingdom

Location

Victoria Hospital /ID# 209853

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Royal Hospital for Children /ID# 210451

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

The Royal Free Hospital /ID# 208659

London, London, City of, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' NHS Found /ID# 208881

London, London, City of, SE1 9RT, United Kingdom

Location

Cardiff & Vale University Health Board /ID# 209745

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (3)

• Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023.

  PMID: 34347860 RESULT

• Simpson EL, Silverberg JI, Prajapati VH, Eyerich K, Katoh N, Boguniewicz M, Guttman-Yassky E, Song EJ, Lee WJ, Teixeira HD, Wu T, Sancho Sanchez C, Vigna N, Calimlim BM, de Bruin-Weller M. Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Aug;15(8):2061-2076. doi: 10.1007/s13555-025-01443-w. Epub 2025 Jun 2.

  PMID: 40457140 DERIVED

• Blauvelt A, Eyerich K, Irvine AD, de Bruin-Weller M, Kwatra SG, Gooderham M, Kim B, Calimlim BM, Lee WJ, Raymundo EM, Liu Y, Ofori S, Platt AM, Silverberg JI. More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2621-2630. doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7.

  PMID: 39110139 DERIVED

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib; dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Study Start: February 21, 2019
• Primary Completion: August 27, 2020
• Study Completion: December 9, 2020
• Last Updated: March 15, 2024
• Results First Posted: February 2, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

DE (6); ES (6); CZ (5); AU (5); CR (4); IL (4); FI (4); HU (5); SG (3); CA (10); IT (7); MY (6); NZ (3); IE (2); US (52); NL (6); FR (7); PL (6); TW (4); UA (3); GB (6); NO (3); SE (2)