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A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207231
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : October 19, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 4, 2014
Results First Submitted Date  ICMJE July 25, 2017
Results First Posted Date  ICMJE October 19, 2017
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 [ Time Frame: Week 16 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • The percentage of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 comparing the guselkumab group and the placebo group [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • The percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response comparing the guselkumab group and the placebo group [ Time Frame: Week 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for 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 an improvement of at least a 90% from baseline in the PASI score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 [ Time Frame: Week 24 and 48 ]
    The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 [ Time Frame: Week 24 and 48 ]
    The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 [ Time Frame: Week 24 and 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.
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group [ Time Frame: Baseline, Week 16 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
  • Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16 [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16 [ Time Frame: Week 16 ]
    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.
  • Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16 [ Time Frame: Week 16 ]
    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 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
  • Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group [ Time Frame: Week 16 ]
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
  • Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group [ Time Frame: Baseline and Week 16 ]
    The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
  • Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24 [ Time Frame: Week 24 ]
    The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • The percentage of participants who achieve an IGA Score 0, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 24 ]
  • The percentage of participants who achieve an IGA Score 0 or 1, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 24 ]
  • The percentage of participants who achieve a PASI 90 Response, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 24 ]
  • The percentage of participants who achieve an IGA score of 0, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 48 ]
  • The percentage of participants who achieve an IGA score of 0 or 1, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 48 ]
  • The percentage of participants who achieve a PASI 90 response, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 48 ]
  • The change from Baseline in Dermatology Life Quality Index (DLQI) score, comparing the guselkumab group and the placebo group [ Time Frame: Week 16 ]
    The DLQI is a participant-reported outcome (PRO) consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
  • The percentage of participants who achieve an IGA score of 0 or 1, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 16 ]
  • The percentage of participants who achieve a PASI 90 response, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 16 ]
  • The percentage of participants who achieve a PASI 75 response, comparing the guselkumab group and the adalimumab group [ Time Frame: Week 16 ]
    A PASI 75 response represents improvement of at least 75% from baseline in the PASI score.
  • The Percentage of participants who achieve a scalp-specific IGA (ss-IGA) score of 0 or 1 and have at least a 2-grade improvement from Baseline [ Time Frame: Week 16 ]
    The ss-IGA assesses the severity of the participant's scalp psoriasis using a 5-point scale that ranges from 0 (absence of disease) to 4 (severe disease). This analysis will compare the guselkumab group and the placebo group among randomized participants with scalp psoriasis and an ss-IGA score ≥2 at baseline.
  • The change from Baseline in Psoriasis Symptom and Sign Diary (PSSD) symptom score, comparing the guselkumab group and the placebo group [ Time Frame: Week 16 ]
    The PSSD is a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consists of 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using a 0 (absent) to 10 (worst imaginable) numerical rating scale for severity. A higher score indicates more severe disease. Two sub-scores are calculated: the psoriasis symptom score and the psoriasis sign score. For this endpoint, only participants with PSSD symptom score greater than or equal to 1 at Baseline will be analyzed.
  • The percentage of participants who achieve a PSSD symptom score of 0, comparing the guselkumab group and adalimumab group [ Time Frame: Week 24 ]
    For this endpoint, only participants with PSSD symptom score greater than or equal to 1 at Baseline will be analyzed.
  • The percentage of participants who achieve an IGA score of 0 and the percentage of participants achieving an IGA score of ≤2 [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo.
  • The percentage of participants who achieve a PASI 100 response, PASI 75 response, and a PASI 50 response at Week 16 [ Time Frame: Week 16 ]
    A PASI 100 response represents improvement of of 100% from baseline in the PASI score, a PASI 75 response represents improvement of at least 75% from baseline in the PASI score, and a PASI 50 response represents improvement of at least 50% from baseline in the PASI score. Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo.
  • The percent improvement from Baseline in PASI response [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo.
  • The percentage of participants who achieve a DLQI score of 0 or 1 [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo. This analysis will be performed among randomized participants with Baseline DLQI >1.
  • The percentage of participants with a reduction of 5 or more points in DLQI score [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo.
  • The percent improvement from Baseline in Nail Psoriasis Area and Severity Index (NAPSI) [ Time Frame: Week 16 ]
    The NAPSI is a sum of 2 scores on the basis of a target nail representing the worst nail psoriasis. The nail is divided into 4 sections (quadrants) and is graded independently for both nail matrix psoriasis and nail bed psoriasis. Scores for nail matrix and nail bed psoriasis range from 0 (none) to 4 (present in all quadrants of the nail). The sum of these 2 scores is the total NAPSI score. Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with nail psoriasis at Baseline.
  • The percentage of participants who achieve an Fingernail Physician's Global Assessment (f-PGA) score of 0 or 1 and have at least 1-grade improvement from Baseline [ Time Frame: Week 16 ]
    The f-PGA is used to evaluate the current status of a participant's fingernail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]). Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with f-PGA ≥2 at Baseline.
  • The percentage of participants who achieve a PSSD symptom score of 0 [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with a Baseline PSSD symptom score ≥1.
  • The percentage of participants who achieve a PSSD sign score of 0 [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with a Baseline PSSD sign score ≥1.
  • The change from Baseline in individual scale score of PSSD components [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo.
  • The percentage of participants who achieve a PSSD individual scale score of 0 [ Time Frame: Week 16 ]
    Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with scale score ≥1 at Baseline.
  • The percentage of participants who achieve an hf-PGA score of 0 or 1 and a reduction of at least 2 grades on the hf-PGA scale from Baseline at Week 16 among randomized participants with hand and/or foot psoriasis and an hf-PGA score ≥2 at Baseline [ Time Frame: Week 16 ]
    The hf-PGA (Physician's Global Assessment of Hands and/or Feet). The scale ranges from 0 (clear) to 4 (severe). Treatment groups to be analyzed: Guselkumab vs Placebo and Adalimumab vs Placebo, among randomized participants with hand and/or foot psoriasis and an hf-PGA score ≥2 at Baseline.
  • The percentage of participants who achieve a PASI 75 response and a PASI 100 response [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab.
  • The percentage of participants who achieve an ss-IGA score of 0 or 1 and at least a 2-grade improvement from Baseline [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab, among randomized participants with scalp psoriasis and an ss-IGA score ≥2 at Baseline.
  • The percent improvement from Baseline in NAPSI [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab, among randomized participants with nail psoriasis at Baseline.
  • The percentage of participants who achieve an f-PGA score of 0 or 1 and have at least a 1-grade improvement from Baseline [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab, among participants with f-PGA ≥2 at Baseline.
  • The percentage of participants who achieve an hf-PGA score of 0 or 1 and at least a 2-grade improvement from Baseline [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab, among randomized participants with hand and/or foot psoriasis and an hf-PGA score ≥2 at Baseline.
  • The percentage of participants who achieve a DLQI score of 0 or 1 [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab, among randomized participants with Baseline DLQI >1.
  • The change from Baseline in the PSSD symptom score [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab vs Adalimumab.
  • The percentage of participants who achieve PSSD symptom score of 0 [ Time Frame: Week 48 ]
    Treatment groups to be analyzed: Guselkumab versus Adalimumab, among randomized participants with a Baseline PSSD symptom score ≥1.
  • The percentage of participants who achieve PSSD sign score of 0 [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab versus Adalimumab, among randomized participants with a Baseline PSSD sign score ≥1.
  • The change from Baseline in individual scale score of PSSD components [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab versus Adalimumab.
  • The percentage of participants who achieve PSSD individual scale score of 0 [ Time Frame: Week 24 and Week 48 ]
    Treatment groups to be analyzed: Guselkumab versus Adalimumab, among randomized participants with scale score ≥1 at Baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Official Title  ICMJE Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
Detailed Description This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab in participants with moderate to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8 weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study is defined as the time the last participant completes the Week 264 visit. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Guselkumab 100 mg
    100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).
    Other Name: CNTO 1959
  • Drug: Placebo for guselkumab
    Subcutaneous injections to maintain the blind.
  • Drug: Adalimumab
    80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
    Other Name: HUMIRA®
  • Drug: Placebo for adalimumab
    Subcutaneous injections to maintain the blind.
Study Arms  ICMJE
  • Experimental: Group I
    Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter [mL] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.
    Interventions:
    • Drug: Guselkumab 100 mg
    • Drug: Placebo for guselkumab
    • Drug: Placebo for adalimumab
  • Placebo Comparator: Group II
    Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.
    Interventions:
    • Drug: Guselkumab 100 mg
    • Drug: Placebo for guselkumab
    • Drug: Placebo for adalimumab
  • Active Comparator: Group III
    Participants received Adalimumab 80 mg at Week 0 (two 40 mg [0.8 mL] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.
    Interventions:
    • Drug: Guselkumab 100 mg
    • Drug: Placebo for guselkumab
    • Drug: Adalimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
837
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2014)
750
Actual Study Completion Date  ICMJE June 2020
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
  • Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
  • Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
  • Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
  • Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

  • Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  • Participants who have ever received guselkumab or adalimumab
  • History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
  • Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Hungary,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02207231
Other Study ID Numbers  ICMJE CR105047
CNTO1959PSO3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-000719-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP