A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2014-000721-20-ES
• Date of registration: 22/09/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
• Scientific title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab - NAVIGATE
• Date of first enrolment: 27/11/2014
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000721-20
• 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: no 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, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Global Clinical Operations Spain
• Affiliation: Janssen Cilag, S.A.

• Name: Global Clinical Operations Spain
• Affiliation: Janssen Cilag, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
- Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
- 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) >=3 at Screening and at Baseline
- Have an involved body surface area (BSA) >= 10 percent (%) at Screening and at Baseline
- Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)
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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
- Has a 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 unstable cardiovascular disease, defined as a recent clinical deterioration (example [eg], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
- Has previously received guselkumab or ustekinumab


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

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: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
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 compare the efficacy of the following 2 treatment paradigms in subjects who have achieved an inadequate (Investigator?s Global Assessment [IGA] ?2) response to ustekinumab at Week 16:
- Switching to guselkumab treatment.
- Remaining on ustekinumab treatment.
? To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis and an inadequate (IGA?2) response to ustekinumab at Week 16.

Secondary Objective: ? To evaluate the effect of switching to guselkumab on patient-reported signs and symptoms of psoriasis for subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
? To assess the PK and immunogenicity of guselkumab after subcutaneous (SC) administrations in subjects with moderate to severe plaque-type psoriasis and an inadequate (IGA?2) response to ustekinumab at Week 16.

Primary end point(s): ? The number of visits at which subjects achieve an IGA response of cleared (0) or minimal (1) and at least a 2 grade improvement (from Week 16) from Week 28 through Week 40, among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.

Timepoint(s) of evaluation of this end point: Week 28 / Week 32/week 36/ week 40

Secondary Outcome(s)

Secondary end point(s): Major Secondary Endpoints
? The number of visits at which subjects achieve a PASI 90 response from Week 28 through Week 40 among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
? The number of visits at which subjects achieve an IGA response of cleared (0) from Week 28 through Week 40 among randomized subjects with an inadequate (IGA?2) response to ustekinumab at Week 16.
? The proportion of subjects who achieve an IGA of 0 or 1 and at least a 2-grade improvement (from Week 16) at Week 28.

Other Secondary Endpoints
Subjects with an inadequate (IGA?2) response to ustekinumab at Week 16
? The number of visits at which subjects achieve a PASI 100 response from Week 28 through Week 40.
? The number of visits at which subjects achieve a PASI 75 response from Week 28 through Week 40.
? The average percent improvement from baseline in PASI response between Week 28 and Week 40.
? The number of visits at which subjects achieve a DLQI of 0 or 1 from Week 28 through Week 40 among randomized subjects with DLQI >1 at Week 16.
? The number of visits at which subjects achieve a PSSD symptom score of 0 from Week 28 through Week 40 among randomized subjects with a PSSD symptom score ?1 at Week 16.
? The number of visits at which subjects achieve a PSSD sign score of 0 from Week 28 through Week 40 among randomized subjects with a PSSD sign score ?1 at Week 16.
? The number of visits at which subjects achieve a score of 0 for each PSSD individual scale from Week 28 through Week 40 among randomized subjects with PSSD scale score ?1 at Week 16.
? The proportion of subjects who achieve a PASI 90 response at Week 28.
? The proportion of subjects who achieve an IGA of 0 or 1 and at least a 2-grade improvement (from Week 16) at Week 52.
? The proportion of subjects who achieve a PASI 90 response at Week 52.
? The proportion of subjects who achieve a PSSD symptom score of 0 at Week 52 among randomized subjects with a PSSD symptom score ?1 at Week 16.
? The proportion of subjects who achieve a PSSD sign score of 0 at Week 52 among randomized subjects with a PSSD sign score ?1 at Week 16.
? The proportion of subjects who achieve DLQI of 0 and 1 at Week 52 among randomized subjects with DLQI >1 at Week 16.
? The proportion of subjects who achieve each PSSD individual score of 0 at Week 52 among randomized subjects with PSSD scale score ?1 at Week 16.

Timepoint(s) of evaluation of this end point: Week 28 / Week 32/week 36/ week 40 / Week 52

Secondary ID(s)

CNTO1959PSO3003

2014-000721-20-GB

Source(s) of Monetary Support

Janssen Research & Development, LLC