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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02207231




Registration number
NCT02207231
Ethics application status
Date submitted
31/07/2014
Date registered
4/08/2014
Date last updated
13/08/2020

Titles & IDs
Public title
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
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
Secondary ID [1] 0 0
CNTO1959PSO3001
Secondary ID [2] 0 0
CR105047
Universal Trial Number (UTN)
Trial acronym
VOYAGE 1
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 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.

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.

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.


Treatment: Drugs: 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).

Treatment: Drugs: Placebo for guselkumab
Subcutaneous injections to maintain the blind.

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 47.

Treatment: Drugs: Placebo for adalimumab
Subcutaneous injections to maintain the blind.

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 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 [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 and 48 - 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 and 48
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 and 48 - 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 and 48
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 and 48 - 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 and 48
Secondary outcome [4] 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. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 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 [5] 0 0
Week 16
Secondary outcome [6] 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 [6] 0 0
Week 16
Secondary outcome [7] 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 [7] 0 0
Week 16
Secondary outcome [8] 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. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 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. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Timepoint [9] 0 0
Baseline and Week 16
Secondary outcome [10] 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 [10] 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
Completed
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
- Darlinghurst
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment hospital [3] 0 0
- Hectorville
Recruitment hospital [4] 0 0
- Liverpool
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Westmead
Recruitment hospital [7] 0 0
- Woden
Recruitment hospital [8] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Hectorville
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment postcode(s) [7] 0 0
- Woden
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment outside Australia
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California
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Colorado
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Bonn
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Essen
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Frankfurt/ Main
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Germany
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Gera
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Germany
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Hamburg
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Kiel
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Lubeck
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Mahlow
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Munster
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Tübingen
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Debrecen
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Pecs
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Szeged
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Bundang
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Busan
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Ekaterinburg
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Kirov
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Krasnodar
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Lipetsk
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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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Stavropol
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Ulyanovsk
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Spain
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Baracaldo
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Barcelona
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Cordoba
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Madrid
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Manises
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Palma de Mallorca
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Salamanca
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San Sebastian de los Reyes
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Valencia
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Taiwan
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Kaohsiung
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Taichung City
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Tainan
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Taipei City
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Taipei
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Taiwan
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Taoyuan

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.
Trial website
https://clinicaltrials.gov/show/NCT02207231
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