Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02207244 |
Date of registration:
|
31/07/2014 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
VOYAGE 2 |
Scientific title:
|
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment |
Date of first enrolment:
|
November 3, 2014 |
Target sample size:
|
993 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02207244 |
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
|
Czech Republic
|
Czechia
|
Germany
|
Korea, Republic of
|
Poland
|
Russian Federation
|
Spain
|
United States
| | | | | | |
Contacts
|
Name:
|
Janssen Research & Development, LLC Clinical Trial |
Address:
|
|
Telephone:
|
|
Email:
|
|
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: Guselkumab 100 mg
|
Drug: Adalimumab
|
Drug: Placebo for adalimumab
|
Drug: Placebo for guselkumab
|
Primary Outcome(s)
|
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]
|
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]
|
Secondary Outcome(s)
|
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) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
[Time Frame: Week 24]
|
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
[Time Frame: Week 24]
|
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 Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16
[Time Frame: Week 16]
|
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) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
[Time Frame: Week 24]
|
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]
|
Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response
[Time Frame: Through Week 48]
|
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 Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
[Time Frame: Week 16]
|
Secondary ID(s)
|
2014-000720-18
|
CR105048
|
CNTO1959PSO3002
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|