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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Secukinumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham
  • Southern California Permanente Medical Group
  • Dermatology Specialists
  • MedDerm Associates
  • San Luis Dermatology & Laser Clinic, Inc
  • Southern California Dermatology
  • Clinical Research Center of Connecticut
  • Olympian Clinical Research
  • Florida Academic Dermatology Centers
  • Renstar Medical Research
  • Park Avenue Dermatology
  • Atlanta Dermatology, Vein & Research Center
  • Advanced Medical Research
  • Marietta Dermatology Clinical Research
  • Arlington Dermatology
  • Northshore Universite Healthsystem
  • Dawes Fretzin Clinical Research Group
  • Indiana Clinical Trial Center
  • Dermatology Specialists
  • DermAssociates, PC
  • Great Lakes Research Group
  • Henry Ford Medical Center
  • Hamzavi Dermatology
  • Somerset Skin Centre
  • Minnesota Clinical Study Center
  • Central Dermatology
  • Windsor Dermatology
  • Academic Dermatology Associates
  • Dermatology Consulting Services, PLLC
  • Dermatologists of Greater Columbus
  • The Ohio State University
  • Central Sooner Research
  • Oregon Dermatology and Research Center
  • Oregon Medical Research Center
  • University of Pittsburgh Department of Dermatology
  • Clinical Partners
  • Austin Dermatology Associates
  • Modern Research Associates
  • Menter Dermatology Research Institute
  • Suzanne Bruce and Associates - The Center for Skin Research
  • Progressive Clinical Research
  • Dermatology Clinical Research Center of San Antonio
  • Virginia Clinical Research
  • Dermatology Associates of Seattle
  • The Skin Centre
  • Sinclair Dermatology
  • Fremantle Dermatology
  • Clinical Trials SA Pty Ltd
  • Premier Specialists
  • St George Dermatology & Skin Cancer Centre
  • Skin&Cancer Foundation Inc
  • Royal Melbourne Hospital
  • Westmead Hospital
  • Woden Dermatology
  • Veracity Clinical Research
  • Dermatrials Research
  • Guenther Dermatology Research Centre
  • North Bay Dermatology Centre
  • Skin Centre for Dermatology
  • Toronto Research Centre
  • CCA Medical Research Corporation
  • Stratica Medical
  • Eastern Canada Research Associates
  • DermEdge Research
  • Innovaderm Research
  • Centre Dermatologique
  • Dr. Chih-ho Hong Medical
  • K. Papp Clinical Research
  • XLR8 Medical Research
  • Nemocnice Jihlava
  • Kozni ambulance Kutna Hora, s.r.o.
  • DERMAMEDICA s.r.o.
  • Nemocnice Novy Jicin a.s.
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • Dermatologicka ambulance
  • Masarykova nemocnice v Usti nad Labem
  • CHU Bordeaux - Hopital St Andre
  • ICH Hopital A. Morvan
  • Groupe Hospitalier La Rochelle - Re - Aunis
  • Le Bateau Blanc
  • CHU Nantes - Hotel Dieu
  • CHU de Nice Hopital de l Archet
  • Hopital Charles Nicolle
  • Hopital Larrey CHU de Toulouse
  • Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
  • ISA GmbH
  • Universitatsklinikum Bonn
  • Klinische Forschung Dresden GmbH
  • University Hospital Dresden
  • Universitatsklinikum Essen
  • Universitatsklinikum Frankfurt
  • Universitaetsklinik Hamburg-Eppendorf
  • SCIderm GmbH
  • MensingDerma research GmbH
  • Universitatsklinikum Schleswig-Holstein - Kiel
  • Universitaetsklinik Luebeck
  • Hautarztpraxis
  • Technische Universitaet Muenchen
  • Universitaetsklinikum Muenster
  • Universitaetsklinik Tuebingen
  • Centrovital
  • Semmelweis Egyetem
  • Debreceni Egyetem Klinikai Kozpont
  • Somogy Megyei Kaposi Mor Oktatokorhaz
  • Bacs-kiskun Megyei Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Pecsi Tudomanyegyetem
  • Szegedi Tudomanyegyetem
  • Markusovszky Egyetemi Oktatokorhaz
  • Medmare Egeszsegugyi Es Szolgaltato Bt.
  • NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
  • Specderm Poznańska sp. j.
  • Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
  • Centrum Kliniczno Badawcze
  • Copernicus Podmiot Leczniczy Sp. z o.o
  • Malopolskie Centrum Medyczne
  • Centrum Badawcze Wspolczesnej Terapii
  • Dermed Centrum Medyczne Sp. z o.o
  • Solumed S.C.
  • CRC Sp. z o.o.
  • Lubelskie Centrum Diagnostyczne
  • NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
  • Przychodnia Specjalistyczna High-Med
  • Wojskowy Instytut Medyczny
  • DermMedica Sp. z o.o.
  • Centrum Medyczne WroMedica
  • Hosp. Univ. Fundacion Alcorcon
  • Hosp. Gral. Univ. de Alicante
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Univ. de Cruces
  • Hosp. Del Mar
  • Hosp. de La Santa Creu I Sant Pau
  • Hosp. Univ. de Basurto
  • Hosp. Reina Sofia
  • Hosp. Univ. Infanta Leonor
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. La Paz
  • Hosp. Univ. de Torrejon
  • Hosp. de Manises
  • Hosp. Provincial de Pontevedra
  • Hosp. Univ. I Politecni La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I: Guselkumab Plus Placebo

Group II: Secukinumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Achieved a PASI-75 Response at Both 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.
Percentage of Participants Who Achieved a PASI-90 Response at 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.
Percentage of Participants Who Achieved a PASI-75 Response at 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.
Percentage of Participants Who Achieved a PASI-100 Response at 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.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at 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).
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at 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).
Percentage of Participants Who Achieved a PASI-90 Response at Both 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.
Percentage of Participants Who Achieved a PASI-75 Response at 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.
Percentage of Participants Who Achieved a PASI-90 Response at 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.
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through 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.
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at 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).
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at 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).
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at 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.
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at 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 percent (%) reduction in PASI relative to baseline.
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 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.
Percentage of Participants With IGA Responses Through Week 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).
Percent Improvement From Baseline in PASI Through 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.

Full Information

First Posted
March 22, 2017
Last Updated
September 6, 2019
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03090100
Brief Title
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Acronym
ECLIPSE
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1048 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I: Guselkumab Plus Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II: Secukinumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Intervention Description
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
Cosentyx
Intervention Description
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
Description
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.
Time Frame
Week 12 and 48
Title
Percentage of Participants Who Achieved a PASI-90 Response at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved a PASI-100 Response at Week 48
Description
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.
Time Frame
Week 48
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
Description
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).
Time Frame
Week 48
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
Description
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).
Time Frame
Week 48
Title
Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Description
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.
Time Frame
Week 16 and 48
Title
Percentage of Participants Who Achieved a PASI-75 Response at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved a PASI-90 Response at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
Description
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.
Time Frame
Week 24 up to Week 48
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
Description
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).
Time Frame
Week 16
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
Description
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).
Time Frame
Week 12
Title
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
Description
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.
Time Frame
Week 48
Title
Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
Description
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.
Time Frame
Week 48
Title
Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
Description
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.
Time Frame
Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Title
Percentage of Participants With IGA Responses Through Week 56
Description
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).
Time Frame
Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Title
Percent Improvement From Baseline in PASI Through Week 56
Description
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.
Time Frame
Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Dermatology Specialists
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
MedDerm Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Luis Dermatology & Laser Clinic, Inc
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Southern California Dermatology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Research Center of Connecticut
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Olympian Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33757
Country
United States
Facility Name
Florida Academic Dermatology Centers
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Advanced Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Marietta Dermatology Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Northshore Universite Healthsystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Indiana Clinical Trial Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
DermAssociates, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Great Lakes Research Group
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Windsor Dermatology
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520-2505
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Dermatologists of Greater Columbus
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
The Ohio State University
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
University of Pittsburgh Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Partners
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Austin Dermatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1615
Country
United States
Facility Name
Suzanne Bruce and Associates - The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056-4132
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23322
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-1498
Country
United States
Facility Name
The Skin Centre
City
Benowa
ZIP/Postal Code
4217
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Clinical Trials SA Pty Ltd
City
Hectorville
ZIP/Postal Code
5073
Country
Australia
Facility Name
Premier Specialists
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
St George Dermatology & Skin Cancer Centre
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Skin&Cancer Foundation Inc
City
Melbourne
ZIP/Postal Code
3053
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Woden Dermatology
City
Woden
ZIP/Postal Code
2606
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Skin Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H5Y8
Country
Canada
Facility Name
CCA Medical Research Corporation
City
Ajax
ZIP/Postal Code
L1S7K8
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Eastern Canada Research Associates
City
Halifax
ZIP/Postal Code
B3H 1Z2
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Innovaderm Research
City
Montreal
ZIP/Postal Code
H2K4L5
Country
Canada
Facility Name
Centre Dermatologique
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical
City
Surrey
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 Medical Research
City
Windsor
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Kozni ambulance Kutna Hora, s.r.o.
City
Kutna Hora
ZIP/Postal Code
248 01
Country
Czechia
Facility Name
DERMAMEDICA s.r.o.
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Nemocnice Novy Jicin a.s.
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava- Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Dermatologicka ambulance
City
Svitavy
ZIP/Postal Code
568 02
Country
Czechia
Facility Name
Masarykova nemocnice v Usti nad Labem
City
Usti Nad Labem
Country
Czechia
Facility Name
CHU Bordeaux - Hopital St Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
ICH Hopital A. Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Groupe Hospitalier La Rochelle - Re - Aunis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Le Bateau Blanc
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
CHU Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice Hopital de l Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Larrey CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
ISA GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinik Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
SCIderm GmbH
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
MensingDerma research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein - Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinik Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Hautarztpraxis
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Technische Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinik Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Centrovital
City
Witten
ZIP/Postal Code
58453
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktatokorhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bacs-kiskun Megyei Korhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Medmare Egeszsegugyi Es Szolgaltato Bt.
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Specderm Poznańska sp. j.
City
Bialystok
ZIP/Postal Code
15-375
Country
Poland
Facility Name
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o
City
Gdansk
ZIP/Postal Code
80-298
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Badawcze Wspolczesnej Terapii
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Dermed Centrum Medyczne Sp. z o.o
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Solumed S.C.
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
CRC Sp. z o.o.
City
Poznan
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Przychodnia Specjalistyczna High-Med
City
Warszawa
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
DermMedica Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Centrum Medyczne WroMedica
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Hosp. Univ. Fundacion Alcorcon
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hosp. Gral. Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Facility Name
Hosp. Univ. de Basurto
City
Bilbao Vizcaya
ZIP/Postal Code
48009
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. de Torrejon
City
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hosp. de Manises
City
Manises
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hosp. Provincial de Pontevedra
City
Pontevedra
ZIP/Postal Code
36003
Country
Spain
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
046026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31402114
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.
Results Reference
derived

Learn more about this trial

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

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