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

NCT ID: NCT03090100

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1048 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2018-09-20

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.

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

Placebo

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Secukinumab

Intervention Type: DRUG

Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.

Interventions

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.

Intervention Type: DRUG

Guselkumab

Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Cosentyx

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Southern California Permanente Medical Group

Los Angeles, California, United States

Dermatology Specialists

Oceanside, California, United States

MedDerm Associates

San Diego, California, United States

San Luis Dermatology & Laser Clinic, Inc

San Luis Obispo, California, United States

Southern California Dermatology

Santa Ana, California, United States

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Olympian Clinical Research

Clearwater, Florida, United States

Florida Academic Dermatology Centers

Coral Gables, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Park Avenue Dermatology

Orange Park, Florida, United States

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, United States

Advanced Medical Research

Atlanta, Georgia, United States

Marietta Dermatology Clinical Research

Marietta, Georgia, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Northshore Universite Healthsystem

Skokie, Illinois, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Dermatology Specialists

Louisville, Kentucky, United States

DermAssociates, PC

Rockville, Maryland, United States

Great Lakes Research Group

Bay City, Michigan, United States

Henry Ford Medical Center

Detroit, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Central Dermatology

St Louis, Missouri, United States

Windsor Dermatology

East Windsor, New Jersey, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Dermatologists of Greater Columbus

Bexley, Ohio, United States

The Ohio State University

Gahanna, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, United States

Clinical Partners

Johnston, Rhode Island, United States

Austin Dermatology Associates

Austin, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Suzanne Bruce and Associates - The Center for Skin Research

Houston, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Dermatology Associates of Seattle

Seattle, Washington, United States

The Skin Centre

Benowa, , Australia

Sinclair Dermatology

East Melbourne, , Australia

Fremantle Dermatology

Fremantle, , Australia

Clinical Trials SA Pty Ltd

Hectorville, , Australia

Premier Specialists

Kogarah, , Australia

St George Dermatology & Skin Cancer Centre

Kogarah, , Australia

Skin&Cancer Foundation Inc

Melbourne, , Australia

Royal Melbourne Hospital

Parkville, , Australia

Westmead Hospital

Westmead, , Australia

Woden Dermatology

Woden, , Australia

Veracity Clinical Research

Woolloongabba, , Australia

Dermatrials Research

Hamilton, Ontario, Canada

Guenther Dermatology Research Centre

London, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

Skin Centre for Dermatology

Peterborough, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

CCA Medical Research Corporation

Ajax, , Canada

Stratica Medical

Edmonton, , Canada

Eastern Canada Research Associates

Halifax, , Canada

DermEdge Research

Mississauga, , Canada

Innovaderm Research

Montreal, , Canada

Centre Dermatologique

Québec, , Canada

Dr. Chih-ho Hong Medical

Surrey, , Canada

K. Papp Clinical Research

Waterloo, , Canada

XLR8 Medical Research

Windsor, , Canada

Nemocnice Jihlava

Jihlava, , Czechia

Kozni ambulance Kutna Hora, s.r.o.

Kutná Hora, , Czechia

DERMAMEDICA s.r.o.

Náchod, , Czechia

Nemocnice Novy Jicin a.s.

Nový Jičín, , Czechia

Fakultni nemocnice Ostrava

Ostrava- Poruba, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Dermatologicka ambulance

Svitavy, , Czechia

Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, , Czechia

CHU Bordeaux - Hopital St Andre

Bordeaux, , France

ICH Hopital A. Morvan

Brest, , France

Groupe Hospitalier La Rochelle - Re - Aunis

La Rochelle, , France

Le Bateau Blanc

Martigues, , France

CHU Nantes - Hotel Dieu

Nantes, , France

CHU de Nice Hopital de l Archet

Nice, , France

Hopital Charles Nicolle

Rouen, , France

Hopital Larrey CHU de Toulouse

Toulouse, , France

Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

Berlin, , Germany

ISA GmbH

Berlin, , Germany

Universitatsklinikum Bonn

Bonn, , Germany

Klinische Forschung Dresden GmbH

Dresden, , Germany

University Hospital Dresden

Dresden, , Germany

Universitatsklinikum Essen

Essen, , Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitaetsklinik Hamburg-Eppendorf

Hamburg, , Germany

SCIderm GmbH

Hamburg, , Germany

MensingDerma research GmbH

Hamburg, , Germany

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , Germany

Universitaetsklinik Luebeck

Lübeck, , Germany

Hautarztpraxis

Mahlow, , Germany

Technische Universitaet Muenchen

München, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Universitaetsklinik Tuebingen

Tübingen, , Germany

Centrovital

Witten, , Germany

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Somogy Megyei Kaposi Mor Oktatokorhaz

Kaposvár, , Hungary

Bacs-kiskun Megyei Korhaz

Kecskemét, , Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprém, , Hungary

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

Bialystok, , Poland

Specderm Poznańska sp. j.

Bialystok, , Poland

Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

Bydgoszcz, , Poland

Centrum Kliniczno Badawcze

Elblag, , Poland

Copernicus Podmiot Leczniczy Sp. z o.o

Gdansk, , Poland

Malopolskie Centrum Medyczne

Krakow, , Poland

Centrum Badawcze Wspolczesnej Terapii

Lodz, , Poland

Dermed Centrum Medyczne Sp. z o.o

Lodz, , Poland

Solumed S.C.

Poznan, , Poland

CRC Sp. z o.o.

Poznan, , Poland

Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm

Torun, , Poland

Przychodnia Specjalistyczna High-Med

Warsaw, , Poland

Wojskowy Instytut Medyczny

Warsaw, , Poland

DermMedica Sp. z o.o.

Wroclaw, , Poland

Centrum Medyczne WroMedica

Wroclaw, , Poland

Hosp. Univ. Fundacion Alcorcon

Alcorcón, , Spain

Hosp. Gral. Univ. de Alicante

Alicante, , Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp. Del Mar

Barcelona, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp. Univ. de Basurto

Bilbao Vizcaya, , Spain

Hosp. Reina Sofia

Córdoba, , Spain

Hosp. Univ. Infanta Leonor

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. de Torrejon

Madrid, , Spain

Hosp. de Manises

Manises, , Spain

Hosp. Provincial de Pontevedra

Pontevedra, , Spain

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Countries

United States; Australia; Canada; Czechia; France; Germany; Hungary; Poland; Spain

References

Blauvelt A, Chen Y, Branigan PJ, Liu X, DePrimo S, Keyes BE, Leung M, Fakharzadeh S, Yang YW, Munoz-Elias EJ, Krueger JG, Langley RG. Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy. JID Innov. 2024 Jun 26;4(5):100297. doi: 10.1016/j.xjidi.2024.100297. eCollection 2024 Sep.

Reference Type: DERIVED

PMID: 39224116 (View on PubMed)

Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.

Reference Type: DERIVED

PMID: 38485863 (View on PubMed)

Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

Reference Type: DERIVED

PMID: 37906417 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31402114 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002995-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSO3009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108278

Identifier Type: -

Identifier Source: org_study_id