A Study of the Efficacy and Safety of JNJ-77242113 in Biologic-naïve 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

3 Apr 2025 → ongoing

Decision date (initial)

2025-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of JNJ-77242113 200 mg and 400 mg versus placebo at Week 16 in participants with active PsA by assessing the reduction in signs and symptoms of PsA

Conditions and MedDRA coding

Active Psoriatic Arthritis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. At least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age.
2. 2. Have a diagnosis of PsA for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.
3. 3. 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) ≥0.1 mg/dL at screening from the central laboratory. NOTE: A one-time repeat assessment of CRP level is allowed during the screening phase and the Investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.
4. 4. Have 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.
5. 5. Have active plaque psoriasis with at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis.
6. 6. Participants must be considered in the opinion of the investigator, to be a suitable candidate for treatment with ustekinumab per locally-approved labeling and have no contraindications to receive ustekinumab per local label.
7. 7. Have active PsA despite current or previous non-biologic DMARD and/or apremilast. Non-biologic DMARD (limited to MTX, SSZ, HCQ, or LEF) therapy is defined as taking a non-biologic DMARD for at least 12 weeks before first administration of study intervention, or evidence of non-biologic DMARD intolerance. Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 12 weeks before first administration of study intervention, or evidence of apremilast intolerance.
8. 8. If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 12 weeks prior 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 stable and ≤ 3 g/day c) If receiving HCQ, the dose must be stable and ≤ 400 mg/day d) If receiving LEF, the dose must be stable and ≤ 20 mg/day (NOTE: use of LEF and MTX combination therapy is not allowed) If using apremilast at baseline, participants must be on a stable dose and ≤ 30 mg twice daily for at least 12 weeks before first administration of study intervention. If currently not using apremilast, the participant must not have received apremilast within 4 weeks before first administration of study intervention. If using NSAIDs for PsA at baseline, participants must be on a stable dose for at least 2 weeks before first administration of study intervention. If currently not using NSAIDs for PsA, must not have received NSAIDs for PsA within 2 weeks before first administration of study intervention. 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 before first administration of study intervention. If currently not using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks before first administration of study intervention.

Exclusion criteria 8

1. 1. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances.
2. 2. Currently has a malignancy or has a history of malignancy within 5 years prior to screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration).
3. 3. Has known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients, or to ustekinumab excipients (refer to the IB).
4. 4. Has unstable cardiovascular disease, defined as a clinical deterioration (eg, unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 12 weeks prior to screening or a cardiac hospitalization within the last 12 weeks prior to screening.
5. 5. Has other inflammatory diseases that might confound the evaluations of benefit of JNJ-77242113 therapy, including but not limited to RA, systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).
6. 6. Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator’s opinion, would have potential to interfere with efficacy assessments.
7. 27. Restricted or Prohibited Medication or Class of Medications: Has previously received the following agents for PsA or psoriasis: - JAK inhibitors, -TYK inhibitors (such as deucravacitinib) Restriction Duration: Ever (ie, any previous use is exclusionary)
8. 28. Restricted or Prohibited Medication or Class of Medications: Has previously received any biologic DMARDs for PsA or psoriasis such as: -Anti-IL-23 agents or biosimilars -Anti-IL-12/23 agents or biosimilars -Abatacept or biosimilars -Anti-IL-17 agent or biosimilars -Anti-TNFα agent or biosimilars Restriction Duration: Ever (ie, any previous use is exclusionary)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the American College of Rheumatology (ACR) 20 response at Week 16

Investigational products

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

Test 3

Placebo 3

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 3

Locations

7 EU/EEA countries · 77 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 116 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