2025-523141-10-00招募中2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants with Active Psoriatic Arthritis
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 161
- 试验地点
- 43
- 主要终点
- ACR50 response at Week 16.
研究概览
简要总结
To evaluate the efficacy of JNJ-88545223 compared with placebo in participants with active PsA.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •At the time of informed consent, be ≥18 years of age.
- •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.
- •Have active APs as defined by: At least 3 swollen joints and 3 tender joints at screening and at baseline (Week 0/Day 1) based on the 66/68 joint assessment; and CRP ≥0.1 mg/dL at screening ≥0.1 mg/dL
- •Have active plaque psoriasis, with ≥1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis
- •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
- •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
- •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.
- •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.
- •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
排除标准
- •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.
- •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).
- •Has other inflammatory diseases that might confound the evaluations of benefit of JNJ 88545223 therapy
- •Have rheumatoid factor or anti-CCP antibody levels at screening that are above the ULN
- •Active hepatitis of infectious origin
- •History of chronic or recurrent infectious disease
研究组 & 干预措施
JNJ-88545223 Placebo
Placebo
干预措施: JNJ-88545223 Placebo (Drug)
JNJ-88545223, JNJ-88545223
Test
干预措施: JNJ-88545223 (Drug)
结局指标
主要结局
ACR50 response at Week 16.
ACR50 response at Week 16.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (43)
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