Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

• Register: EUCTR
• Last refreshed on: 31 January 2017
• Main ID: EUCTR2014-003697-17-ES
• Date of registration: 27/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
• Scientific title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis
• Date of first enrolment: 27/05/2015
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003697-17
• 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: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Germany, Poland, Romania, Russian Federation, Spain, 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:
- Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
- Had active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline b. C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
- Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
- Has active PsA despite current or previous non-biologic diseasemodifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable
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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion criteria:
- Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
- Has previously received guselkumab or ustekinumab - Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
- Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
- Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug


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

Health Condition(s) or Problem(s) studied

Active Psoriatic Arthritis
MedDRA version: 17.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-

Primary Outcome(s)

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

Primary end point(s): Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24

Main Objective: - To evaluate the efficacy of guselkumab in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.
- To assess the safety and tolerability of guselkumab in subjects with active PsA.

Secondary Objective: The secondary objectives are:
- To evaluate the efficacy of guselkumab in improving physical function.
- To evaluate the impact of guselkumab on quality of life.
- To evaluate the efficacy of guselkumab on psoriatic skin lesions.
- To evaluate the PK and immunogenicity of guselkumab in subjects with active PsA.
- To evaluate the PD characteristics of guselkumab with and without MTX in subjects with active PsA.
- To evaluate the efficacy and safety of guselkumab following 1 year of exposure.

The exploratory objectives are:
- To evaluate the correlation between PK and PD characteristics of guselkumab in subjects with PsA.
- To use ultrasound to evaluate the changes in musculoskeletal abnormalities (enthesitis, tenosynovitis, and synovitis) from baseline in patients with active PsA treated with guselkumab as compared to placebo)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - secundary end point 1, 4 & 5 at baseline & week 24
- secundary end point 2 at week 16
- secundary end point 3 & 6 at week 24

Secondary end point(s): 1. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24
2. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 16
3. Percentage of Participants who Achieve an ACR 50 Response at Week 24
4. Percent Improvement in Enthesitis Scores at Week 24 Among Participants with Enthesitis at Baseline
5. Percent Improvement in Dactylitis Scores at Week 24 Among Participants with Dactylitis at Baseline
6. Percentage of Participants who Achieve a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24

Secondary ID(s)

CNTO1959PSA2001

2014-003697-17-DE

Source(s) of Monetary Support

Janssen Research & Development, LLC