A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis (ECLIPSE)

• ClinicalTrials.gov Identifier: NCT03090100
• Recruitment Status: Completed
• First Posted: March 24, 2017
• Results First Posted: October 1, 2019
• Last Update Posted: October 1, 2019
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Guselkumab; Drug: Placebo; Drug: Secukinumab	Phase 3

Detailed Description:

The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1048 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
• Actual Study Start Date: April 27, 2017
• Actual Primary Completion Date: August 2, 2018
• Actual Study Completion Date: September 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group I: Guselkumab Plus Placebo; Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind.	Drug: Guselkumab; Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.; Drug: Placebo; Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
Active Comparator: Group II: Secukinumab; Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.	Drug: Secukinumab; Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.; Other Name: Cosentyx

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 [ Time Frame: Week 48 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 [ Time Frame: Week 12 and 48 ]
   Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
2. Percentage of Participants Who Achieved a PASI-90 Response at Week 12 [ Time Frame: Week 12 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
3. Percentage of Participants Who Achieved a PASI-75 Response at Week 12 [ Time Frame: Week 12 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
4. Percentage of Participants Who Achieved a PASI-100 Response at Week 48 [ Time Frame: Week 48 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
5. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 [ Time Frame: Week 48 ]
   The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
6. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 [ Time Frame: Week 48 ]
   The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
7. Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 [ Time Frame: Week 16 and 48 ]
   Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
8. Percentage of Participants Who Achieved a PASI-75 Response at Week 16 [ Time Frame: Week 16 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
9. Percentage of Participants Who Achieved a PASI-90 Response at Week 16 [ Time Frame: Week 16 ]
   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
10. Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 [ Time Frame: Week 24 up to Week 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
11. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
12. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ]
    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
13. Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 [ Time Frame: Week 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
14. Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 [ Time Frame: Week 48 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
15. Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 [ Time Frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 ]
    PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.
16. Percentage of Participants With IGA Responses Through Week 56 [ Time Frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 ]
    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
17. Percent Improvement From Baseline in PASI Through Week 56 [ Time Frame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
• Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has previously received guselkumab or secukinumab
• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
• Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Contacts and Locations

Locations

United States, Alabama

University of Alabama Birmingham

Birmingham, Alabama, United States, 35233

United States, California

Southern California Permanente Medical Group

Los Angeles, California, United States, 90027

Dermatology Specialists

Oceanside, California, United States, 92056

MedDerm Associates

San Diego, California, United States, 92103

San Luis Dermatology & Laser Clinic, Inc

San Luis Obispo, California, United States, 93405

Southern California Dermatology

Santa Ana, California, United States, 92701

United States, Connecticut

Clinical Research Center of Connecticut

Danbury, Connecticut, United States, 06810

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33757

Florida Academic Dermatology Centers

Coral Gables, Florida, United States, 33134

Renstar Medical Research

Ocala, Florida, United States, 34470

Park Avenue Dermatology

Orange Park, Florida, United States, 32073

United States, Georgia

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, United States, 30022

Advanced Medical Research

Atlanta, Georgia, United States, 30328

Marietta Dermatology Clinical Research

Marietta, Georgia, United States, 30060

United States, Illinois

Arlington Dermatology

Rolling Meadows, Illinois, United States, 60008

Northshore Universite Healthsystem

Skokie, Illinois, United States, 60077

United States, Indiana

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States, 46256

Indiana Clinical Trial Center

Plainfield, Indiana, United States, 46168

United States, Kentucky

Dermatology Specialists

Louisville, Kentucky, United States, 40241

United States, Maryland

DermAssociates, PC

Rockville, Maryland, United States, 20850

United States, Michigan

Great Lakes Research Group

Bay City, Michigan, United States, 48706

Henry Ford Medical Center

Detroit, Michigan, United States, 49202

Hamzavi Dermatology

Fort Gratiot, Michigan, United States, 48059

Somerset Skin Centre

Troy, Michigan, United States, 48084

United States, Minnesota

Minnesota Clinical Study Center

Fridley, Minnesota, United States, 55432

United States, Missouri

Central Dermatology

Saint Louis, Missouri, United States, 63117

United States, New Jersey

Windsor Dermatology

East Windsor, New Jersey, United States, 08520-2505

United States, New Mexico

Academic Dermatology Associates

Albuquerque, New Mexico, United States, 87106

United States, North Carolina

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States, 27262

United States, Ohio

Dermatologists of Greater Columbus

Bexley, Ohio, United States, 43209

The Ohio State University

Gahanna, Ohio, United States, 43230

United States, Oklahoma

Central Sooner Research

Norman, Oklahoma, United States, 73071

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

Oregon Medical Research Center

Portland, Oregon, United States, 97223

United States, Pennsylvania

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Clinical Partners

Johnston, Rhode Island, United States, 02919

United States, Texas

Austin Dermatology Associates

Austin, Texas, United States, 78705

Modern Research Associates

Dallas, Texas, United States, 75231

Menter Dermatology Research Institute

Dallas, Texas, United States, 75246-1615

Suzanne Bruce and Associates - The Center for Skin Research

Houston, Texas, United States, 77056-4132

Progressive Clinical Research

San Antonio, Texas, United States, 78213

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States, 78229

United States, Virginia

Virginia Clinical Research

Norfolk, Virginia, United States, 23322

United States, Washington

Dermatology Associates of Seattle

Seattle, Washington, United States, 98101-1498

Australia

The Skin Centre

Benowa, Australia, 4217

Sinclair Dermatology

East Melbourne, Australia, 3002

Fremantle Dermatology

Fremantle, Australia, 6160

Clinical Trials SA Pty Ltd

Hectorville, Australia, 5073

Premier Specialists

Kogarah, Australia, 2217

St George Dermatology & Skin Cancer Centre

Kogarah, Australia, 2217

Skin&Cancer Foundation Inc

Melbourne, Australia, 3053

Royal Melbourne Hospital

Parkville, Australia, 3050

Westmead Hospital

Westmead, Australia, 2145

Woden Dermatology

Woden, Australia, 2606

Veracity Clinical Research

Woolloongabba, Australia, 4102

Canada, Ontario

Dermatrials Research

Hamilton, Ontario, Canada, L8N 1Y2

Guenther Dermatology Research Centre

London, Ontario, Canada, N6A 3H7

North Bay Dermatology Centre

North Bay, Ontario, Canada, P1B 3Z7

Skin Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

Toronto Research Centre

Toronto, Ontario, Canada, M3H5Y8

Canada

CCA Medical Research Corporation

Ajax, Canada, L1S7K8

Stratica Medical

Edmonton, Canada, T5K 1X3

Eastern Canada Research Associates

Halifax, Canada, B3H 1Z2

DermEdge Research

Mississauga, Canada, L5H 1G9

Innovaderm Research

Montreal, Canada, H2K4L5

Centre Dermatologique

Quebec, Canada, G1V 4X7

Dr. Chih-ho Hong Medical

Surrey, Canada, V3R 6A7

K. Papp Clinical Research

Waterloo, Canada, N2J 1C4

XLR8 Medical Research

Windsor, Canada, N8W 1E6

Czechia

Nemocnice Jihlava

Jihlava, Czechia, 586 33

Kozni ambulance Kutna Hora, s.r.o.

Kutna Hora, Czechia, 248 01

DERMAMEDICA s.r.o.

Nachod, Czechia, 547 01

Nemocnice Novy Jicin a.s.

Novy Jicin, Czechia, 741 01

Fakultni nemocnice Ostrava

Ostrava- Poruba, Czechia, 708 52

Fakultni nemocnice Kralovske Vinohrady

Praha, Czechia, 775 20

Dermatologicka ambulance

Svitavy, Czechia, 568 02

Masarykova nemocnice v Usti nad Labem

Usti Nad Labem, Czechia

France

CHU Bordeaux - Hopital St Andre

Bordeaux, France, 33000

ICH Hopital A. Morvan

Brest, France, 29200

Groupe Hospitalier La Rochelle - Re - Aunis

La Rochelle, France, 17019

Le Bateau Blanc

Martigues, France, 13500

CHU Nantes - Hotel Dieu

Nantes, France, 44093

CHU de Nice Hopital de l Archet

Nice, France, 06200

Hopital Charles Nicolle

Rouen, France, 76031

Hopital Larrey CHU de Toulouse

Toulouse, France, 31000

Germany

Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

Berlin, Germany, 10117

ISA GmbH

Berlin, Germany, 10789

Universitatsklinikum Bonn

Bonn, Germany, 53105

Klinische Forschung Dresden GmbH

Dresden, Germany, 01069

University Hospital Dresden

Dresden, Germany, 01307

Universitatsklinikum Essen

Essen, Germany, 45122

Universitatsklinikum Frankfurt

Frankfurt am Main, Germany, 60590

Universitaetsklinik Hamburg-Eppendorf

Hamburg, Germany, 20246

SCIderm GmbH

Hamburg, Germany, 20354

MensingDerma research GmbH

Hamburg, Germany, 22391

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, Germany, 24105

Universitaetsklinik Luebeck

Luebeck, Germany, 23538

Hautarztpraxis

Mahlow, Germany, 15831

Technische Universitaet Muenchen

Muenchen, Germany, 80802

Universitaetsklinikum Muenster

Muenster, Germany, 48149

Universitaetsklinik Tuebingen

Tuebingen, Germany, 72076

Centrovital

Witten, Germany, 58453

Hungary

Semmelweis Egyetem

Budapest, Hungary, 1085

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Somogy Megyei Kaposi Mor Oktatokorhaz

Kaposvar, Hungary, 7400

Bacs-kiskun Megyei Korhaz

Kecskemet, Hungary, 6000

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, Hungary, 3529

Pecsi Tudomanyegyetem

Pecs, Hungary, 7632

Szegedi Tudomanyegyetem

Szeged, Hungary, 6720

Markusovszky Egyetemi Oktatokorhaz

Szombathely, Hungary, 9700

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprem, Hungary, 8200

Poland

NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik

Bialystok, Poland, 15-351

Specderm Poznańska sp. j.

Bialystok, Poland, 15-375

Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

Bydgoszcz, Poland, 85-094

Centrum Kliniczno Badawcze

Elblag, Poland, 82-300

Copernicus Podmiot Leczniczy Sp. z o.o

Gdansk, Poland, 80-298

Malopolskie Centrum Medyczne

Krakow, Poland, 30-510

Centrum Badawcze Wspolczesnej Terapii

Lodz, Poland, 90-242

Dermed Centrum Medyczne Sp. z o.o

Lodz, Poland, 90-265

Solumed S.C.

Poznan, Poland, 60-529

CRC Sp. z o.o.

Poznan, Poland, 60-848

Lubelskie Centrum Diagnostyczne

Swidnik, Poland, 21-040

NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm

Torun, Poland, 87-100

Przychodnia Specjalistyczna High-Med

Warszawa, Poland, 01-817

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

DermMedica Sp. z o.o.

Wroclaw, Poland, 51-318

Centrum Medyczne WroMedica

Wroclaw, Poland, 51-685

Spain

Hosp. Univ. Fundacion Alcorcon

Alcorcon, Spain, 28922

Hosp. Gral. Univ. de Alicante

Alicante, Spain, 03010

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain, 08916

Hosp. Univ. de Cruces

Barakaldo, Spain, 48903

Hosp. Del Mar

Barcelona, Spain, 08003

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain, 8041

Hosp. Univ. de Basurto

Bilbao Vizcaya, Spain, 48009

Hosp. Reina Sofia

Cordoba, Spain, 14004

Hosp. Univ. Infanta Leonor

Madrid, Spain, 28031

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Hosp. Univ. La Paz

Madrid, Spain, 28046

Hosp. Univ. de Torrejon

Madrid, Spain, 28850

Hosp. de Manises

Manises, Spain, 46940

Hosp. Provincial de Pontevedra

Pontevedra, Spain, 36003

Hosp. Univ. I Politecni La Fe

Valencia, Spain, 046026

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] October 5, 2017

Statistical Analysis Plan  [PDF] February 8, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03090100
• Other Study ID Numbers: CR108278; 2016-002995-29 ( EudraCT Number ); CNTO1959PSO3009 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: March 24, 2017
• Results First Posted: October 1, 2019
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases