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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT02207231
• Date of registration: 31/07/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis VOYAGE 1
• Scientific 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
• Date of first enrolment: November 26, 2014
• Target sample size: 837
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02207231
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: Placebo for guselkumab

Drug: Guselkumab 100 mg

Drug: Adalimumab

Drug: Placebo for adalimumab

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252 [Time Frame: Week 252]

Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252 [Time Frame: Week 252]

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]

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]

Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252 [Time Frame: Week 252]

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]

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]

Percentage of Participants With a DLQI Score of 0 or 1 at Week 252 [Time Frame: Week 252]

Percentage of Participants Who Achieved PASI 75 Response at Week 252 [Time Frame: Week 252]

Percentage of Participants Who Achieved PASI 90 Response at Week 252 [Time Frame: Week 252]

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]

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]

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]

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]

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]

Secondary ID(s)

CNTO1959PSO3001

2014-000719-15

CR105047

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02207231