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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04936308




Registration number
NCT04936308
Ethics application status
Date submitted
16/06/2021
Date registered
23/06/2021

Titles & IDs
Public title
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Scientific title
A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent
Secondary ID [1] 0 0
2021-000482-32
Secondary ID [2] 0 0
CR109039
Universal Trial Number (UTN)
Trial acronym
SOLSTICE
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 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 placebo SC and will cross over to receive guselkumab SC.


Treatment: Drugs: Guselkumab
Participants will receive guselkumab as SC injection.

Treatment: Drugs: Placebo
Participants will receive matching placebo as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in HAQ-DI Score at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants who Achieve ACR 20 Response at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Percentage of Participants who Achieve ACR 50 Response at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Participants who Achieve ACR 50 Response at Week 24
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Percentage of Participants who Achieve ACR 70 Response at Week 24
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Timepoint [11] 0 0
Up to 112 weeks
Secondary outcome [12] 0 0
Percentage of Participants With AEs leading to Discontinuation of Study Intervention
Timepoint [12] 0 0
Up to 112 weeks
Secondary outcome [13] 0 0
Percentage of Participants With Infections
Timepoint [13] 0 0
Up to 112 weeks
Secondary outcome [14] 0 0
Percentage of Participants With Injection-site Reactions
Timepoint [14] 0 0
Up to 100 weeks
Secondary outcome [15] 0 0
Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Timepoint [15] 0 0
Up to 112 weeks
Secondary outcome [16] 0 0
Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity
Timepoint [16] 0 0
Up to 112 weeks
Secondary outcome [17] 0 0
Serum Guselkumab Concentration
Timepoint [17] 0 0
Up to 112 weeks
Secondary outcome [18] 0 0
Percentage of Participants With Anti-guselkumab Antibodies
Timepoint [18] 0 0
Up to 112 weeks

Eligibility
Key inclusion criteria
* Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
* Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
* Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
* Has ever received 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
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/09/2026
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southern Clinical Research - Hobart
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Skin Health Institute Inc. - Melbourne
Recruitment hospital [4] 0 0
Eastern Health - Box Hill Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3053 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Connecticut
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Illinois
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Louisiana
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Maryland
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Michigan
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Missouri
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Istanbul
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Konya
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Kyiv
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Poltava
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Vinnytsya
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Ukraine
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Zaporizhzhya

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
Participate-In-This-Study@its.jnj.com
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/NCT04936308