A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis

• Register: EUCTR
• Last refreshed on: 15 September 2020
• Main ID: EUCTR2014-000719-15-HU
• Date of registration: 22/09/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis
• 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 - VOYAGE 1
• Date of first enrolment: 14/11/2014
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000719-15
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, United States

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

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
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 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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 wellbeing) 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

Health Condition(s) or Problem(s) studied

Moderate to Severe Plaque Type Psoriasis
MedDRA version: 19.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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

Primary Outcome(s)

Main Objective: • To evaluate the efficacy of guselkumab for 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.

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.

Secondary Objective: • To compare the efficacy of guselkumab to adalimumab in subjects with moderate to severe plaque type psoriasis.
• 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.

Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome(s)

Secondary end point(s): Major Secondary Endpoints

• The proportion of subjects who achieve an IGA score of cleared (0) at Week 24, comparing the guselkumab group and the adalimumab group.
• The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) 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 proportion of subjects who achieve an IGA score of cleared (0) at Week 48, comparing the guselkumab group and the adalimumab group.
• The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) at Week 48, comparing the guselkumab group and the adalimumab group.
• The proportion of subjects who achieve a PASI 90 response at Week 48, comparing the guselkumab group and the adalimumab group.
• The change from baseline in DLQI score at Week 16, comparing the guselkumab group and placebo group.
• The proportion of subjects who achieve an IGA score of cleared (0) or minimal (1) 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 (0) or very mild disease (1) and have at least a 2-grade improvement from baseline at Week 16, comparing the guselkumab group and 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 placebo group.
• The proportion of subjects who achieve a PSSD symptom score=0 at Week 24, comparing the guselkumab group and the adalimumab group among randomized subjects with a baseline PSSD symptom score =1.


Other Secondary Endpoints


Placebo Comparisons (Guselkumab vs Placebo and Adalimumab vs Placebo)

• The proportion of subjects who achieve an IGA score of cleared (0) and the proportion of subjects achieving an IGA score of mild or better (=2) at Week 16.
• The proportion of subjects who achieve PASI 100, PASI 75, and PASI 50 responses 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 the 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 (0) or minimal (1) and have at least a 1 grade improvement from baseline at Week 16 among randomized subjects with an f PGA score =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.
• 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.

Guselkumab vs Adalimumab

• The proportion of subjects who achieve a PASI 75 response and a PASI 100 response at Week 24 and Week 48.
• The proportion of subjects who achieve an ss-IGA score of absence of disease (0) or very mild disease (1) and have at least a 2-grade improvement from baseline at Week 24 and Week 48 among randomized subjects with scalp psoriasis and an ss-IGA score =2 at baseline.
• The percent improvement from baseline in NAPSI at Week 24 and Week 48 among randomized subjects with nail psoriasis at baseline.
• The proportion of subjects who achieve an f-PGA score of clear (0) or minimal (1) and have at least 1-grade improvement from baseline at Week 24 and Week 48 among randomized subjects with an f PGA score =2 at baseline.
• The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and have at least a 2-grade improvement from baseline at Week 24 and Week 48 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 and Week 48 among randomized subjects with baseline DLQI >1.

See protocol for other secondary endpoints

Timepoint(s) of evaluation of this end point: Week 16/ Week 24/ Week 48

Secondary ID(s)

2014-000719-15-DE

CNTO1959PSO3001

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 03/11/2014
Contact: