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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04929210




Registration number
NCT04929210
Ethics application status
Date submitted
11/06/2021
Date registered
18/06/2021

Titles & IDs
Public title
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Scientific title
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Secondary ID [1] 0 0
2021-000465-32
Secondary ID [2] 0 0
CR109043
Universal Trial Number (UTN)
Trial acronym
STAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo

Experimental: Group 1: Guselkumab and Placebo - Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.

Experimental: Group 2: Guselkumab - Participants will receive guselkumab SC.

Experimental: Group 3: Placebo followed by Guselkumab - Participants will receive matching placebo and will cross over to receive guselkumab SC.


Treatment: Drugs: Guselkumab
Guselkumab will be administered as subcutaneous injection.

Treatment: Drugs: Placebo
Matching placebo will be administered as subcutaneous injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Change from Baseline in SPARCC Score for MRI Spine at Week 24
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [11] 0 0
Up to 60 weeks
Secondary outcome [12] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [12] 0 0
Up to 60 weeks
Secondary outcome [13] 0 0
Number of Participants with Reasonably Related AEs
Timepoint [13] 0 0
Up to 60 weeks
Secondary outcome [14] 0 0
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Timepoint [14] 0 0
Up to 60 weeks
Secondary outcome [15] 0 0
Number of Participants with Infections
Timepoint [15] 0 0
Up to 60 weeks
Secondary outcome [16] 0 0
Number of participants with Injection-Site Reactions
Timepoint [16] 0 0
Up to 60 weeks
Secondary outcome [17] 0 0
Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
Timepoint [17] 0 0
Up to 60 weeks
Secondary outcome [18] 0 0
Serum Guselkumab Concentration Over Time
Timepoint [18] 0 0
Up to 60 weeks
Secondary outcome [19] 0 0
Number of Participants with Antibodies to Guselkumab
Timepoint [19] 0 0
Up to 60 weeks

Eligibility
Key inclusion criteria
* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/11/2026
Actual
Sample size
Target
405
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Emeritus Research - Camberwell
Recruitment hospital [2] 0 0
Southern Clinical Research - Hobart
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [5] 0 0
Skin Health Institute Inc. - Melbourne
Recruitment hospital [6] 0 0
Eastern Health - Box Hill Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment postcode(s) [5] 0 0
3053 - Melbourne
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment outside Australia
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Kharkiv
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Khmelnytsky
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Kyiv
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Barnet
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Bradford
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Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04929210