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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02207231
First received: July 31, 2014
Last updated: July 11, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: Guselkumab 100 mg Drug: Placebo for guselkumab Drug: Adalimumab Drug: Placebo for adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 837
Actual Study Start Date: November 26, 2014
Estimated Study Completion Date: June 10, 2020
Primary Completion Date: September 29, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Placebo for adalimumab
Subcutaneous injections to maintain the blind.
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.
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: Placebo for adalimumab
Subcutaneous injections to maintain the blind.
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.
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®

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.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207231

  Show 98 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02207231     History of Changes
Other Study ID Numbers: CR105047
CNTO1959PSO3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-000719-15 ( EudraCT Number )
Study First Received: July 31, 2014
Last Updated: July 11, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Psoriasis
Plaque-type psoriasis
Guselkumab
Adalimumab
CNTO 1959
Monoclonal antibody

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017