Active Psoriatic Arthritis
Conditions
Interventions
Control group:Placebo po qd (weeks 0 to 16)
100mg dose group:JNJ-88545223 100 mg po qd (weeks 0 to 16)
300mg dose group:JNJ-88545223 300 mg po qd (weeks 0 to 16)
600mg dose group:JNJ-88545223 600 mg po qd (weeks 0 to 16)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent form; 2. Diagnosed with psoriatic arthritis (PsA) at least 3 months prior to first dose of study drug, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening; 3. Has active PsA, defined as: (1) At least 3 swollen joints and 3 tender joints at both screening and baseline (Week 0/Day 1); and (2) C-reactive protein (CRP) >=0.1 mg/dL from central laboratory testing at screening; 4. Has at least one of the following PsA subtypes: distal interphalangeal joint involvement, polyarthritis (without rheumatoid nodules), asymmetric peripheral arthritis, or spondylitis with peripheral arthritis; 5. Has active plaque psoriasis at screening and baseline (Week 0/Day 1), with at least one psoriatic plaque >=2 cm in diameter or nail changes consistent with psoriasis; 6. Has active PsA despite prior or current use of at least one of the following: (1) Conventional disease-modifying antirheumatic drugs (DMARDs); (2) Apremilast; (3) Anti-tumor necrosis factor (TNF) agents; 7. If currently using a conventional DMARD, the subject must have been on stable dosing for at least 4 weeks and initiated treatment at least 12 weeks prior to first dose of study drug, with no severe toxicities attributable to the conventional DMARD; 8. If currently using apremilast at baseline (Week 0/Day 1), the subject must have received a stable dose (<=30 mg twice daily) for at least 12 weeks prior to first dose of study drug. If not currently using apremilast, it must not have been used in the prior 4 weeks before first dose of study drug; 9. If currently using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for PsA at baseline (Week 0/Day 1), the subject must have been on stable dosing for at least 2 weeks prior to first dose of study drug. If not currently using NSAIDs or other analgesics for PsA, they must not have been used in the prior 2 weeks before first dose of study drug; 10. If currently using oral corticosteroids at baseline (Week 0/Day 1), the subject must have been on stable dosing (equivalent to <=10 mg prednisone/day) for at least 2 weeks prior to first dose of study drug. If not currently using oral corticosteroids, they must not have been used in the prior 2 weeks before first dose of study drug; 11. For female subjects, during study drug treatment and for at least 90 days after the last dose of study drug, they must: (1) Not be breastfeeding or pregnant; (2) Not donate gametes (i.e., oocytes) or cryopreserve gametes for future use in assisted reproduction; (3) If of childbearing potential, must: 1) Have a negative high-sensitivity serum pregnancy test (e.g., ß-human chorionic gonadotropin [ß-hCG]) at screening and a negative urine pregnancy test at baseline (Week 0/Day 1); 2) Agree to undergo additional pregnancy testing; 3) Use at least one highly effective contraceptive method; 4) If fertility status changes after study initiation (e.g., premenarchal female subjects begin menstruation) or pregnancy risk changes (e.g., a female subject with no sexual activity with a male partner begins such activity), she must immediately begin using a highly effective contraceptive method; 12. For male subjects, during study drug treatment and for at least 90 days after the last dose of study drug, they must: (1) Not donate gametes (i.e., sperm) or cryopreserve gametes for future use in assisted reproduction; (2) Use external condo
Exclusion criteria
Exclusion criteria: 1. Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular); 2. Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); 3. Has other inflammatory diseases that might confound the evaluations of benefit of JNJ-88545223 therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and/or Lyme disease; 4. A current diagnosis or history of inflammatory bowel disease (IBD); 5. 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; 6. Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments; 7. Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo; or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food; 8. Has had major surgery (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study; 9. Has a transplanted organ (except for a corneal transplant >=12 weeks before the first administration of study intervention); 10. Presence of active suicidal ideation, or positive suicidal behavior using the "screening" version of the electronic Columbia Suicide Severity Rating Scale (C-SSRS) as per the criteria defined in protocol; 11. History or evidence for any of the following: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure (CHF), arterial or venous thromboembolic events (for example, pulmonary embolism, cerebrovascular accident, including TIAs) within 12 months prior to screening; 12. Previously received JNJ-88545223 ever (that is, any previous use is exclusionary); 13. Has received greater than (>) 2 different anti-tumor necrosis factor agents (TNFi, originator or respective biosimilar) anytime prior to the first dose of study intervention; 14. Has received an investigational intervention (other than for PsA or psoriasis [PsO]) or used an invasive investigational medical device within 90 days or 5 half-lives, whichever is longer, prior to the planned first dose of study intervention; 15. Has received any of the following within 1 week or 5 half-lives of the drug, whichever is longer, prior to the first administration of study intervention: (1) Moderate to strong inhibitors of cytochrome (CY) P3A4 (except for grapefruit and grapefruit juice); (2) Moderate to strong inducers of CYP3A4; (3) Substrate sensitive to inhibition of both breast cancer resistance protein (BRCP) and organic anion transporting polypeptide (OATP) 1B1; 16. Has used complementary/alternative therapies for PsA or PsO and/or topical medications/treatments that could affect PsO evaluations, as defined per protocol within 2 weeks prior to the first administration of study intervention. Low-potency topical corticosteroids on the face or groin are allowed at any time; 17. Has received any systemic immunosuppressants other than methotrexate (MTX) (azathio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The American College of Rheumatology (ACR) 50 response at week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Number of Participants With Laboratory Abnormalities;The PASI100 response at week 16 (for subjects with baseline BSA>=3% and IGA>=2;The PASI90 response at week 16 (for subjects with baseline BSA>=3% and IGA>=2;ACR20 response at Week 16.;Change from baseline in HAQ-DI score at Week 16.;The psoriasis area and severity index 75 response at week 16 (for subjects with baseline BSA>=3% and IGA>=2);ACR70 response at Week 16.;Change from baseline in SF-36 PCS at Week 16;Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); | — |
Countries
China
Contacts
Public ContactSu Yin
Peking University People's Hospital
Outcome results
None listed