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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2014-000720-18-ES |
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Date of registration:
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22/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis with Randomized Withdrawal and Retreatment
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Scientific title:
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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 - VOYAGE 2 |
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Date of first enrolment:
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21/11/2014 |
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Target sample size:
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1000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000720-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Canada
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Czech Republic
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Germany
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Korea, Republic of
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Poland
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Russian Federation
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Spain
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United States
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Contacts
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Name:
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Global Clinical Operations Spain
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Address:
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Pº Doce Estrellas, 5-7
28042
Madrid
Spain |
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Telephone:
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+3491722 81 00 |
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Email:
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agonza45@its.jnj.com |
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Affiliation:
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Janssen Cilag, S.A. |
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Name:
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Global Clinical Operations Spain
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Address:
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Pº Doce Estrellas, 5-7
28042
Madrid
Spain |
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Telephone:
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+3491722 81 00 |
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Email:
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agonza45@its.jnj.com |
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Affiliation:
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Janssen Cilag, S.A. |
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Key inclusion & exclusion criteria
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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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
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:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate to Severe Plaque Type Psoriasis
MedDRA version: 17.0
Level: PT
Classification code 10037153
Term: Psoriasis
System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Product Name: Guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Guselkumab
Current Sponsor code: CNTO1959
Other descriptive name: GUSELKUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: ? To compare the efficacy of guselkumab to adalimumab in subjects with moderate to severe plaque-type psoriasis.
? To evaluate the maintenance of response to guselkumab in subjects continuing on a 100 mg q8w regimen compared with the maintenance of response in subjects who have active treatment withdrawn.
? To evaluate the effect of treatment with guselkumab on other measures of signs and symptoms of psoriasis.
? To evaluate the effect of treatment with guselkumab on health-related quality of life and health economic outcomes.
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Primary end point(s): The co-primary endpoints are the proportions of subjects who achieve an IGA score of cleared (0) or minimal (1) and the proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the placebo group.
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Main Objective: ? To evaluate the efficacy of guselkumab in the treatment of subjects with moderate to severe plaque-type psoriasis.
? To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis.
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Timepoint(s) of evaluation of this end point: Week 16
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 16/ Week 24/ Week 48
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Secondary end point(s): ? The proportion of subjects who achieve an IGA score of cleared at Week 24, comparing the guselkumab group and the adalimumab group.
? The proportion of subjects who achieve an IGA score of cleared or minimal at Week 24, comparing the guselkumab group and the adalimumab group.
? The proportion of subjects who achieve a PASI 90 response at Week 24, comparing the guselkumab group and the adalimumab group.
? The time to loss of PASI 90 response through Week 48, comparing subjects randomized to placebo and subjects randomized to continue guselkumab 100 mg q8w at Week 28.
? The change from baseline in DLQI score at Week 16, comparing the guselkumab group and the placebo group.
? The proportion of subjects who achieve an IGA score of cleared or minimal at Week 16, comparing the guselkumab group and the adalimumab group.
? The proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the adalimumab group.
? The proportion of subjects who achieve a PASI 75 response at Week 16, comparing the guselkumab group and the adalimumab group.
? The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and have at least a 2-grade improvement from baseline at Week 16, comparing the guselkumab group and the placebo group among randomized subjects with scalp psoriasis and an ss-IGA score ?2 at baseline.
? The change from baseline in PSSD symptom score at Week 16, comparing the guselkumab group and the placebo group.
? The proportion of subjects who achieve a PSSD symptom score=0 at Week 24, comparing the guselkumab group and adalimumab group among randomized subjects with a baseline PSSD symptom score ?1.
Other Secondary Endpoints
Placebo Comparisons
? The proportion of subjects who achieve an IGA score of cleared and the proportion of subjects achieving an IGA score of mild or better (?2) at Week 16.
? The proportion of subjects who achieve a PASI 100 response, PASI 75 response, and a PASI 50 response at Week 16.
? The percent improvement from baseline in PASI response through Week 16.
? The proportion of subjects who achieve a DLQI score=0 or 1 at Week 16 among randomized subjects with baseline DLQI>1.
? The proportion of subjects with a reduction of 5 or more points in DLQI score at Week 16.
? The percent improvement from baseline in NAPSI at Week 16 among randomized subjects with nail psoriasis at baseline.
? The proportion of subjects who achieve an f-PGA score of clear or minimal and have at last 1 grade improvement from baseline at Week 16 among randomized subjects with f PGA ?2 at baseline.
? The proportion of subjects who achieve a PSSD symptom score=0 at Week 16 among randomized subjects with a baseline PSSD symptom score ?1.
? The proportion of subjects who achieve a PSSD sign score=0 at Week 16 among randomized subjects with a baseline PSSD sign score ?1.
? The change from baseline in individual scale score of PSSD components at Week 16 among randomized subjects.
? The proportion of subjects who achieve PSSD individual scale score of 0 at Week 16 among randomized subjects with scale score ?1 at baseline.
? The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and a reduction of at least 2 grades on the hf-PGA scale from baseline at Week 16 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ?2 at baseline.
? Change from baseline in the physical and mental component summary scores of SF-36 at Week 16.
? The change from baseline in HADS at Week 16.
? The change from baseline in WLQ at Week 16.
Guselkumab versus Adalimumab
? The proportion of subjects who achieve a PASI 75 response and a PASI 100 response at Week 24.
?The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with scalp psoriasis and an ss-IGA score ?2 at baseline.
? The percent improvement from baseline in NAPSI at Week 24 among randomized subjects with nail psoriasis at baseline.
? The proportion of subjects who achieve an f-PGA score of clear or minimal and have at least a 1-grade improvement from baseline at Week 24 among subjects with f-PGA ?2 at baseline.
? The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ?2 at baseline.
? The proportion of subjects who achieve a DLQI score=0 or 1 at Week 24 among randomized subjects with baseline DLQI>1.
? The change from baseline in the PSSD symptom score at Week 24.
Please see protocol for other secondary endpoints
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Secondary ID(s)
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CNTO1959PSO3002
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2014-000720-18-DE
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Ethics review
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Status: Approved
Approval date: 14/11/2014
Contact:
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