A Study of the Efficacy and Safety of Guselkumab in Participants with Active Psoriatic Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

30 Aug 2021 → ongoing

Decision date (initial)

2024-07-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Janssen Research & Development

External identifiers

EU CT number

2023-504734-21-00

EudraCT number

2020-004981-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Others, Safety, Pharmacokinetic, Efficacy

To evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Conditions and MedDRA coding

Psoriatic arthritis (PsA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
2. Have active plaque psoriasis, with at least one psoriatic plaque of ≥ 2cm diameter and/or nail changes consistent with psoriasis.
3. If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention.
4. If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention.
5. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
6. Have a diagnosis of 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.
7. Have active PsA as defined by: a. At least three swollen joints and three tender joints at screening and at baseline -AND- b. CRP ≥ 0.3 mg/dL at screening from the central laboratory.
8. Have ≥2 joints with erosions on baseline radiographs of the hands and feet as determined by central read.
9. 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.
10. If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a.If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. b.If receiving SSZ, the dose must be ≤3g/day. c.If receiving HCQ, the dose must be ≤400 mg/day. d.If receiving LEF, the dose must be ≤20 mg/day.

Exclusion criteria 9

1. Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients.
2. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr- axSpA), systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).
3. Has the arthritis mutilans subset of PsA.
4. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis.
5. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor.
6. Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention.
7. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
8. Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: participants cannot be on concomitant MTX and LEF.
9. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 3) within 4 weeks of the first administration of study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with American College of Rheumatology (ACR) 20 response at Week 24.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 12

Locations

14 EU/EEA countries · 92 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 290 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications