Clinical trial NCT03090100: A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 1048
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
timeFrame: Week 12 and 48
measure: Percentage of Participants Who Achieved a PASI-90 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved a PASI-75 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved a PASI-100 Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
timeFrame: Week 48
measure: Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
timeFrame: Week 16 and 48
measure: Percentage of Participants Who Achieved a PASI-75 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a PASI-90 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
timeFrame: Week 24 up to Week 48
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
timeFrame: Week 48
measure: Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
timeFrame: Week 48
measure: Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
timeFrame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
measure: Percentage of Participants With IGA Responses Through Week 56
timeFrame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
measure: Percent Improvement From Baseline in PASI Through Week 56
timeFrame: Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic, Inc
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: Northshore Universite Healthsystem
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Bexley
country: United States
facility: Dermatologists of Greater Columbus
state: Ohio
city: Gahanna
country: United States
facility: The Ohio State University
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates - The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Benowa
country: Australia
facility: The Skin Centre
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Fremantle
country: Australia
facility: Fremantle Dermatology
city: Hectorville
country: Australia
facility: Clinical Trials SA Pty Ltd
city: Kogarah
country: Australia
facility: Premier Specialists
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre
city: Melbourne
country: Australia
facility: Skin&Cancer Foundation Inc
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Woden
country: Australia
facility: Woden Dermatology
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: Guenther Dermatology Research Centre
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
city: Edmonton
country: Canada
facility: Stratica Medical
city: Halifax
country: Canada
facility: Eastern Canada Research Associates
city: Mississauga
country: Canada
facility: DermEdge Research
city: Montreal
country: Canada
facility: Innovaderm Research
city: Quebec
country: Canada
facility: Centre Dermatologique
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
city: Windsor
country: Canada
facility: XLR8 Medical Research
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora, s.r.o.
city: Nachod
country: Czechia
facility: DERMAMEDICA s.r.o.
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
city: Ostrava- Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Svitavy
country: Czechia
facility: Dermatologicka ambulance
city: Usti Nad Labem
country: Czechia
facility: Masarykova nemocnice v Usti nad Labem
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital St Andre
city: Brest
country: France
facility: ICH Hopital A. Morvan
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle - Re - Aunis
city: Martigues
country: France
facility: Le Bateau Blanc
city: Nantes
country: France
facility: CHU Nantes - Hotel Dieu
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Toulouse
country: France
facility: Hopital Larrey CHU de Toulouse
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
city: Berlin
country: Germany
facility: ISA GmbH
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: SCIderm GmbH
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein - Kiel
city: Luebeck
country: Germany
facility: Universitaetsklinik Luebeck
city: Mahlow
country: Germany
facility: Hautarztpraxis
city: Muenchen
country: Germany
facility: Technische Universitaet Muenchen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Tuebingen
country: Germany
facility: Universitaetsklinik Tuebingen
city: Witten
country: Germany
facility: Centrovital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktatokorhaz
city: Kecskemet
country: Hungary
facility: Bacs-kiskun Megyei Korhaz
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Veszprem
country: Hungary
facility: Medmare Egeszsegugyi Es Szolgaltato Bt.
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
city: Bialystok
country: Poland
facility: Specderm Poznańska sp. j.
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Lodz
country: Poland
facility: Centrum Badawcze Wspolczesnej Terapii
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o
city: Poznan
country: Poland
facility: Solumed S.C.
city: Poznan
country: Poland
facility: CRC Sp. z o.o.
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Torun
country: Poland
facility: NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna High-Med
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Wroclaw
country: Poland
facility: DermMedica Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne WroMedica
city: Alcorcon
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Bilbao Vizcaya
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp. Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. de Torrejon
city: Manises
country: Spain
facility: Hosp. de Manises
city: Pontevedra
country: Spain
facility: Hosp. Provincial de Pontevedra
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.