EUCTR2019-003182-17-PL进行中（未招募）1 期
A Phase II, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging, proof-of-concept trial of BI 730357 given for 12 weeks in patients with active psoriatic arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years and = 75 years at screening, males or females
- •2. Signed and dated written informed consent in accordance with ICH-GCP and local
- •legislation prior to admission to the trial
- •3. Have PsA symptoms for = 6 months prior to screening, as assessed by the investigator
- •4. Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR)
- •with peripheral symptoms at screening visit, as assessed by the investigator
- •5. Have = 3 tender joints and = 3 swollen joints at screening and randomisation visits, as
- •assessed by the investigator
- •6. At least one PsO skin or nail lesion or a documented personal history of PsO at
- •screening, as assessed by the investigator
- •7. If patients receive concurrent PsA treatments, these need to be on stable doses as below:
- •- For patients receiving MTX: patient has received treatment for = 3 months, with
- •stable dose and stable route of administration (not to exceed 20 mg MTX per week)
- •for = 4 weeks prior to randomisation to EOO; patients on MTX should be taking
- •folic acid supplementation according to local standard of care before randomisation
- •and during the trial to minimize the likelihood of MTX associated toxicity
- •- For patients receiving oral corticosteroids: the patient must be on a stable dose (not
- •to exceed the equivalent of 10 mg of prednisone per day) for = 2 weeks prior to
- •randomisation to EOO,
- •- For patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) or
- •paracetamol/acetaminophen PRN: the patient must be on stable dose for = 2 weeks
- •prior to randomisation to EOO
- •8. Women of child-bearing potential (WoCBP)** must be ready and able to use highly
- •effective methods of birth control per ICH M3 (R2) that result in a low failure rate of
- •less than 1% per year when used consistently and correctly. Such methods should be
- •used throughout the study and the patient must agree to periodic pregnancy testing
- •during participation in the trial. There are no specific contraceptive requirements for male participants.
- •Patients (males or females) following the national regulatory guidelines regarding
- •contraception if receiving MTX as background therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Major chronic inflammatory or connective tissue disease other than PsA (e.g.
- •rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme
- •disease, gout) or fibromyalgia, as assessed by the investigator
- •2. Active uveitis or uveitis within 4 weeks prior to randomisation, assessed by the
- •investigator
- •3. Suspected or diagnosed inflammatory bowel disease, assessed by the investigator
- •4. Previous exposure to BI 730357
- •5. Prior use of any therapeutic agent directly targeted to IL-12/23, IL-23 or IL-17
- •6. Prior use of more than two different TNFi agents
- •7. Use of the following treatments:
- •- TNFi agents (including, infliximab, adalimumab, certolizumab pegol or
- •golimumab) within 8 weeks prior to randomisation
- •- Etanercept within 4 weeks prior to randomisation
- •- Leflunomide without cholestyramine wash-out within 8 weeks prior to
- •randomisation
- •- Systemic non-biologic medications for PsA or PsO (including traditional DMARDs,
- •apremilast, a JAK inhibitor or leflunomide with cholestyramine wash-out) or
- •photochemotherapy within 4 weeks prior to randomisation
- •- Intraarticular injections (including steroids) and intramuscular or intravenous
- •corticosteroid treatment within 4 weeks prior to randomisation
- •- Topical PsO medications and phototherapy within 2 weeks prior to randomisation,
- •- Low and high potency opioid analgesics (e.g. tramadol, methadone, hydromorphone,
- •morphine) within 2 weeks prior to randomisation
- •8. Live vaccination = 12 weeks prior to randomisation (visit 2), or any plan to receive a
- •live vaccination during the conduct of this study. BCG vaccination is restricted 1 year
- •prior to randomisation through EOO visit.
- •Further criteria apply.
研究者
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