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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02207244




Registration number
NCT02207244
Ethics application status
Date submitted
31/07/2014
Date registered
4/08/2014
Date last updated
22/07/2021

Titles & IDs
Public title
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
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
Secondary ID [1] 0 0
CNTO1959PSO3002
Secondary ID [2] 0 0
CR105048
Universal Trial Number (UTN)
Trial acronym
VOYAGE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab 100 mg
Treatment: Drugs - Placebo for guselkumab
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo for adalimumab

Experimental: Group I - Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Placebo comparator: Group II - Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. 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 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.

Active comparator: Group III - Participants will receive adalimumab 80 mg (two 40 mg \[0.8 mL\] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.


Treatment: Drugs: Guselkumab 100 mg
100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Treatment: Drugs: Placebo for guselkumab
Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

Treatment: Drugs: Adalimumab
80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.

Treatment: Drugs: Placebo for adalimumab
Placebo for adalimumab \[two 0.8 milliliter (mL) injections\] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Through Week 48
Secondary outcome [5] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response
Timepoint [12] 0 0
Through Week 72
Secondary outcome [13] 0 0
Percentage of Participants Who Achieved PASI 90 Response at Week 252
Timepoint [13] 0 0
Week 252
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved PASI 75 Response at Week 252
Timepoint [14] 0 0
Week 252
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
Timepoint [15] 0 0
Week 252
Secondary outcome [16] 0 0
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
Timepoint [16] 0 0
Week 252
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
Timepoint [17] 0 0
Week 252
Secondary outcome [18] 0 0
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
Timepoint [18] 0 0
Week 252

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2020
Sample size
Target
Accrual to date
Final
992
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Benowa
Recruitment hospital [2] 0 0
- Hectorville
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Westmead
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Benowa
Recruitment postcode(s) [2] 0 0
- Hectorville
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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Colorado
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Massachusetts
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Michigan
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Missouri
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New Mexico
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Texas
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Utah
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Washington
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Canada
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Ontario
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Czechia
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Jihlava
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Czechia
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Nachod
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Czechia
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Pardubice
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Plzen
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Czechia
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Praha 10
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Czechia
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Praha 5
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Czechia
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Usti nad Labem
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Germany
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Dresden
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Germany
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Gera
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Hamburg
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Kiel
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Leipzig
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Lubeck
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Munster
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Germany
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Tübingen
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Germany
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Witten
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Busan
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Daejeon
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Gwangju
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Incheon
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Seongnam
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Seoul
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Suwon
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Bialystok
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Bydgoszcz
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Gdansk
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Lodz
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Lublin
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Poznan
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Torun
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Warszawa
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Cherepovets
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Moscow
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Rostov-on-Don
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Ryazan
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St-Petersburg
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St. Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Badalona
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Spain
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Barcelona
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Bilbao Vizcaya
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Madrid
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Spain
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Murcia
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Spain
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Pontevedra
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02207244