EUCTR2016-003937-62-HU进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects 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
- 360
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
入选标准
- •1. Subject has provided written informed consent.
- •2. Subject is = 18 years of age at time of Screening.
- •3. Subject has a diagnosis of PsA (by the Classification of PsA criteria) with symptoms present for at least 6 months.
- •4. Subject has = 3 tender and = 3 swollen joints at Screening and Baseline.
- •5. For subjects receiving non-steroidal anti-inflammatory drugs (NSAIDs, including as needed [PRN] use): subject must be on stable dose for = 4 weeks prior to initiation of IMP and be expected to maintain a stable dose for the first 24 weeks of the study, unless change in dosage is required due to toxicity. Stable dose (including PRN use) is defined as subjects taking an NSAID on average 4 days per week for the 4-week period prior to Screening.
- •6. For subjects receiving non-drug therapy (including but not limited to physical therapy, massage, diet, exercise, emollients, and joint taping), this must be stable for the 4-week period prior to IMP initiation through to the end of Part 1.
- •7. For subjects receiving methotrexate (MTX) or leflunomide: subject has received treatment for at least 3 months, with a stable dose and method of dosing (not to exceed 25 mg MTX per week or 20 mg leflunomide per day) for at least 8 weeks prior to initiation of IMP, and be expected to maintain a stable dose for the first 24 weeks of the study, unless change in dosage is required due to toxicity. Subjects may not be receiving both leflunomide and MTX concomitantly.
- •8. For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for = 4 weeks prior to initiation of IMP, and be expected to maintain a stable dose for the first 24 weeks of the study.
- •9. Subject has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive or 2 successive indeterminate QuantiFERON tests are allowed if they have the following:
- •- no history of active TB or symptoms of TB,
- •- posterior-anterior (PA) chest radiogram (with associated report available at site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases),
- •- if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
- •- if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to inclusion in the study.
- •A maximum of 2 QuantiFERON test are allowed. A re-test is only permitted if the first is indeterminate, the result of the second test will then be used.
- •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 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.
- •2. Subject has an active infection or history of infections as follows:
- •- any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,
- •- a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
- •- recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that might cause this study to be detrimental to the subject.
- •3. Major chronic inflammatory or connective tissue disease other than PsA (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme disease, gout); PsA with spondylitis and/or sacroiliitis is permitted.
- •4. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease, that, in the opinion of the Investigator, could cause this study to be detrimental to the subject.
- •5. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- •6. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
- •7. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- •8. Subject has a history of malignancy within 5 years EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
- •9. Subjects with a history of alcohol or drug abuse in the previous 2 years.
- •10. Significant risk of suicidality at the Screening assessment based on the Investigator's judgement or, if appropriate, as indicated by the response of yes within the last 12 months to question 4 or 5 in the suicidal section, or any response in the behavioral section of the C-SSRS.
- •11. Subject has laboratory abnormalities at Screening, including any of the following:
- •- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 times the upper limit of normal (ULN),
- •- creatinine = 1.5 times the ULN,
- •- serum direct bilirubin = 1.5 mg/dL,
- •- white blood cell count < 3.0 x 103/µL,
- •- positive test result for rheumatoid factor,
- •- any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
- •12. Subject has used any of the following within 28 days of IMP initiation:
- •- high potency opioid analgesics
- •- sulfasalazine,
- •- hydroxychloroquine,
- •- systemically administered calcineurin inhibitors
- •- azathioprine,
- •- topical and parenteral corticosteroids including intramuscular or intra-articular administration,
- •- live vaccines,
- •- has a need for use of a
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