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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02207244
Ethics application status
Date submitted
31/07/2014
Date registered
4/08/2014
Date last updated
30/06/2020

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 - 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).
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 - 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 area was 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.
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 - 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).
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 - 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).
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 - 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.
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 - 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. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.
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 - 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.
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 - 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).
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
Timepoint [11] 0 0
Week 24

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Alabama
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United States of America
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California
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Colorado
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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United States of America
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Kentucky
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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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United States of America
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Oklahoma
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United States of America
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Oregon
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Pennsylvania
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United States of America
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Rhode Island
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Texas
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Utah
Country [21] 0 0
United States of America
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Washington
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Czechia
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Jihlava
Country [24] 0 0
Czechia
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Nachod
Country [25] 0 0
Czechia
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Pardubice
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Czechia
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Plzen
Country [27] 0 0
Czechia
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Praha 10
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Czechia
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Praha 5
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Czechia
State/province [29] 0 0
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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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Lubeck
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Germany
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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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Korea, Republic of
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Busan
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Olsztyn
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Poland
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Poznan
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Poland
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Torun
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Poland
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Warszawa
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Poland
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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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Russian Federation
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Moscow
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Ryazan
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Russian Federation
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St-Petersburg
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Russian Federation
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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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Spain
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Bilbao Vizcaya
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Spain
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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
State/province [71] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
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
(scaly skin rash).
Trial website
https://clinicaltrials.gov/show/NCT02207244
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

Summary results
Other publications