A study to learn about the effectiveness and safety of different doses of JNJ-88545223 in people 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

20 Mar 2026 → ongoing

Decision date (initial)

2026-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of JNJ-88545223 compared with placebo in participants with active PsA.

Conditions and MedDRA coding

Active Psoriatic Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. At the time of informed consent, be ≥18 years of age.
2. 2. Have a diagnosis of PsA for ≥3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.
3. 3. Have active APs as defined by: At least 3 swollen joints and 3 tender joints at screening and at baseline (Week 0/Day 1); and CRP ≥0.1 mg/dL at screening ≥0.1 mg/dL
4. 4. Have active plaque psoriasis, with ≥1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis
5. 5. Have active PsA despite current or previous use of ≥1 of the following: a. Conventional DMARDs Conventional DMARD (limited to MTX, SSZ, HCQ, and/or LEF) therapy is defined as taking a conventional DMARD for ≥12 weeks before first administration of study intervention, or evidence of conventional DMARD intolerance. b. Apremilast Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for ≥12 weeks before first administration of study intervention, or evidence of apremilast intolerance. c. Anti-TNF agents Must have experienced either: i. Inadequate response to TNFi treatment at an approved dose, as assessed by the treating physician, after ≥12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) or ≥14 weeks of infliximab (or biosimilar); OR ii. Stopped TNFi treatment due to safety/tolerability reasons, as assessed by the treating physician. Limited to prior use of up to 2 different TNFi
6. 6. If currently using conventional DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment ≥12 weeks and the dose must be stable for ≥4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the conventional DMARD. If currently not using MTX, SSZ, or HCQ, must have been off such medication(s) for at least 4 weeks before first the administration of study intervention. If currently not using LEF, must have been off this medication for at least 12 weeks before the first administration of study intervention. a. If using MTX, the route of administration and dose must be stable at ≤25 mg/week b. If receiving SSZ, the dose must be stable at ≤3 g/day c. If receiving HCQ, the dose must be stable at ≤400 mg/day d. If receiving LEF, the dose must be stable at ≤20 mg/day
7. 7. If using apremilast at baseline (Week 0/Day 1), participants must be on a stable dose at ≤30 mg twice daily for ≥12 weeks before first administration of study intervention. If currently not using apremilast, must have been off this medication for at least 4 weeks before the first administration of study intervention.
8. 8. If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for ≥2 weeks before first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must have been off such medication(s) for at least 2 weeks before first administration of study intervention.
9. 9. If using oral corticosteroids at baseline (Week 0/Day 1), participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for ≥2 weeks before first administration of study intervention. If currently not using oral corticosteroids, must have been off such medication(s) for at least 2 weeks before the first administration of study intervention

Exclusion criteria 6

1. 1. Has a history or current signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, and/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 ≥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 ≥12 weeks prior to the first study intervention administration).
3. 3. Has other inflammatory diseases that might confound the evaluations of benefit of JNJ 88545223 therapy
4. 4. Have rheumatoid factor or anti-CCP antibody levels at screening that are above the ULN
5. 5. Active hepatitis of infectious origin
6. 6. History of chronic or recurrent infectious disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ACR50 response at Week 16.

Investigational products

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

Test 2

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 3

Locations

5 EU/EEA countries · 42 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 80 files

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

Application history

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