A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
ECLIPSE
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
3 other identifiers
interventional
1,048
9 countries
142
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2018
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 1, 2019
September 1, 2019
1.3 years
March 22, 2017
August 1, 2019
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at 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.
Week 48
Secondary Outcomes (17)
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Week 12 and 48
Percentage of Participants Who Achieved a PASI-90 Response at Week 12
Week 12
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
Week 12
Percentage of Participants Who Achieved a PASI-100 Response at Week 48
Week 48
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
Week 48
- +12 more secondary outcomes
Study Arms (2)
Group I: Guselkumab Plus Placebo
EXPERIMENTALParticipants 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 II: Secukinumab
ACTIVE COMPARATORParticipants 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.
Interventions
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
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.
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (142)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Dermatology Specialists
Oceanside, California, 92056, United States
MedDerm Associates
San Diego, California, 92103, United States
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo, California, 93405, United States
Southern California Dermatology
Santa Ana, California, 92701, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810, United States
Olympian Clinical Research
Clearwater, Florida, 33757, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022, United States
Advanced Medical Research
Atlanta, Georgia, 30328, United States
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Northshore Universite Healthsystem
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
Indiana Clinical Trial Center
Plainfield, Indiana, 46168, United States
Dermatology Specialists
Louisville, Kentucky, 40241, United States
DermAssociates, PC
Rockville, Maryland, 20850, United States
Great Lakes Research Group
Bay City, Michigan, 48706, United States
Henry Ford Medical Center
Detroit, Michigan, 49202, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Central Dermatology
St Louis, Missouri, 63117, United States
Windsor Dermatology
East Windsor, New Jersey, 08520-2505, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262, United States
Dermatologists of Greater Columbus
Bexley, Ohio, 43209, United States
The Ohio State University
Gahanna, Ohio, 43230, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
Clinical Partners
Johnston, Rhode Island, 02919, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246-1615, United States
Suzanne Bruce and Associates - The Center for Skin Research
Houston, Texas, 77056-4132, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Virginia Clinical Research
Norfolk, Virginia, 23322, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101-1498, United States
The Skin Centre
Benowa, 4217, Australia
Sinclair Dermatology
East Melbourne, 3002, Australia
Fremantle Dermatology
Fremantle, 6160, Australia
Clinical Trials SA Pty Ltd
Hectorville, 5073, Australia
Premier Specialists
Kogarah, 2217, Australia
St George Dermatology & Skin Cancer Centre
Kogarah, 2217, Australia
Skin&Cancer Foundation Inc
Melbourne, 3053, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Westmead Hospital
Westmead, 2145, Australia
Woden Dermatology
Woden, 2606, Australia
Veracity Clinical Research
Woolloongabba, 4102, Australia
Dermatrials Research
Hamilton, Ontario, L8N 1Y2, Canada
Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Toronto Research Centre
Toronto, Ontario, M3H5Y8, Canada
CCA Medical Research Corporation
Ajax, L1S7K8, Canada
Stratica Medical
Edmonton, T5K 1X3, Canada
Eastern Canada Research Associates
Halifax, B3H 1Z2, Canada
DermEdge Research
Mississauga, L5H 1G9, Canada
Innovaderm Research
Montreal, H2K4L5, Canada
Centre Dermatologique
Québec, G1V 4X7, Canada
Dr. Chih-ho Hong Medical
Surrey, V3R 6A7, Canada
K. Papp Clinical Research
Waterloo, N2J 1C4, Canada
XLR8 Medical Research
Windsor, N8W 1E6, Canada
Nemocnice Jihlava
Jihlava, 586 33, Czechia
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, 248 01, Czechia
DERMAMEDICA s.r.o.
Náchod, 547 01, Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, 741 01, Czechia
Fakultni nemocnice Ostrava
Ostrava- Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 775 20, Czechia
Dermatologicka ambulance
Svitavy, 568 02, Czechia
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia
CHU Bordeaux - Hopital St Andre
Bordeaux, 33000, France
ICH Hopital A. Morvan
Brest, 29200, France
Groupe Hospitalier La Rochelle - Re - Aunis
La Rochelle, 17019, France
Le Bateau Blanc
Martigues, 13500, France
CHU Nantes - Hotel Dieu
Nantes, 44093, France
CHU de Nice Hopital de l Archet
Nice, 06200, France
Hopital Charles Nicolle
Rouen, 76031, France
Hopital Larrey CHU de Toulouse
Toulouse, 31000, France
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
Berlin, 10117, Germany
ISA GmbH
Berlin, 10789, Germany
Universitatsklinikum Bonn
Bonn, 53105, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
University Hospital Dresden
Dresden, 01307, Germany
Universitatsklinikum Essen
Essen, 45122, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitaetsklinik Hamburg-Eppendorf
Hamburg, 20246, Germany
SCIderm GmbH
Hamburg, 20354, Germany
MensingDerma research GmbH
Hamburg, 22391, Germany
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, 24105, Germany
Universitaetsklinik Luebeck
Lübeck, 23538, Germany
Hautarztpraxis
Mahlow, 15831, Germany
Technische Universitaet Muenchen
München, 80802, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitaetsklinik Tuebingen
Tübingen, 72076, Germany
Centrovital
Witten, 58453, Germany
Semmelweis Egyetem
Budapest, 1085, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Somogy Megyei Kaposi Mor Oktatokorhaz
Kaposvár, 7400, Hungary
Bacs-kiskun Megyei Korhaz
Kecskemét, 6000, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3529, Hungary
Pecsi Tudomanyegyetem
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700, Hungary
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprém, 8200, Hungary
NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
Bialystok, 15-351, Poland
Specderm Poznańska sp. j.
Bialystok, 15-375, Poland
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
Bydgoszcz, 85-094, Poland
Centrum Kliniczno Badawcze
Elblag, 82-300, Poland
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, 80-298, Poland
Malopolskie Centrum Medyczne
Krakow, 30-510, Poland
Centrum Badawcze Wspolczesnej Terapii
Lodz, 90-242, Poland
Dermed Centrum Medyczne Sp. z o.o
Lodz, 90-265, Poland
Solumed S.C.
Poznan, 60-529, Poland
CRC Sp. z o.o.
Poznan, 60-848, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040, Poland
NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
Torun, 87-100, Poland
Przychodnia Specjalistyczna High-Med
Warsaw, 01-817, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
DermMedica Sp. z o.o.
Wroclaw, 51-318, Poland
Centrum Medyczne WroMedica
Wroclaw, 51-685, Poland
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922, Spain
Hosp. Gral. Univ. de Alicante
Alicante, 03010, Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp. Univ. de Cruces
Barakaldo, 48903, Spain
Hosp. Del Mar
Barcelona, 08003, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 8041, Spain
Hosp. Univ. de Basurto
Bilbao Vizcaya, 48009, Spain
Hosp. Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. de Torrejon
Madrid, 28850, Spain
Hosp. de Manises
Manises, 46940, Spain
Hosp. Provincial de Pontevedra
Pontevedra, 36003, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 046026, Spain
Related Publications (4)
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.
PMID: 39224116DERIVEDEgeberg 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.
PMID: 38485863DERIVEDStrober 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.
PMID: 37906417DERIVEDReich 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.
PMID: 31402114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2017
First Posted
March 24, 2017
Study Start
April 27, 2017
Primary Completion
August 2, 2018
Study Completion
September 20, 2018
Last Updated
October 1, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-09