EUCTR2020-000956-37-CZ进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naive Subjects with Active Psoriatic Arthritis II (INSPIRE 2)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
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. Subject has provided written informed consent.
- •2. Subject is = 18 years of age at time of Screening.
- •3. Subject has a diagnosis of active PsA (by the Classification of PsA
- •criteria, APPENDIX 1) for at least 6 months before the first
- •administration of the study agent and has active PsA confirmed at
- •Screening orand Baseline.
- •4. Subject has = 3 tender and = 3 swollen joints at Screening and
- •Baseline (dactylitis)
- •Note: Dactylitis of a digit counts as one joint eachfor the purpose of
- •eligibility assessment. However, the individual joints will be counted for the efficacy assessments of Tender joint count (TJC) or Swollen joint count (SJC).
- •5. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
- •6. Diagnosis of active plaque PsO, with at least one psoriatic plaque of = 2 cm diameter at Screening or a documented history of plaque PsO.
- •7. Subjects must have no prior exposure to anti-tumor necrosis factor
- •(anti-TNF) agent(s) use for the treatment of PsO or PsA.
- •8. For subjects receiving non-steroidal anti-inflammatory drugs
- •(NSAIDs) or low potency opioids (e.g. only tramadol, meperidine, and
- •codeine allowed), including as needed (PRN) use: the subject must be on a 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 a change in dosage is required due to toxicity. Stable dose and PRN use are defined as subjects taking an NSAID or low- potency- opioids on average 4 days per week over the 4-week period prior to Screening.
- •9. 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 4week4week period prior to IMP initiation through to the end of Study Period.double blinded study period (Week 24).
- •10. For subjects receiving methotrexate (MTX) or leflunomide: subject has received treatment for at least 3 months, with a stable dose and method of dosing (methotrexate: oral or subcutaneous injection; leflunomide: (oral) (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 a change in dosage is required due to toxicity. Subjects may not be receiving both leflunomide and MTX concomitantly.
- •11. 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.
- •12. 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 all of the following:
- •-no history of active TB or symptoms of TB,
- •-a posterior-anterior (PA) chest radiograph (with associated report
- •available at the site) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious
- •-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 at least 4 weeks, prior to dosing in the study at visit 2-week 0.
- •A maximum of 2 QuantiFERON test
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 (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening, Any recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
- •3. Major chronic inflammatory or connective tissue disease other than PsA; 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 participation in 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.
- •-Following algorithm shall be followed for all subjects for Hepatitis B or Hepatitis C to evaluate this exclusion criteria. Subjects having Hepatitis B surface antigen (HBsAg) positive will be excluded from the study. Subjects having HBsAg negative test shall be tested for Hepatitis B core antibody (Anti-HBc). Subjects with negative Anti-HBc can be included in the study. Subjects with positive Anti-HBc shall further be tested for Hepatitis B virus deoxyribonucleic acid (HBV-DNA). Subjects tested negative for HBV-DNA shall be included in the study. Subjects tested positive for HBV-DNA shall be excluded from the study. In the event the HBV DNA test cannot be performed, the subject shall NOT be considered eligible for this study.
- •Subjects with Hepatitis C viral (HCV) antibody non-reactive will be
- •included in the study. Subjects with Hepatitis C viral (HCV) antibody
- •reactive, shall be tested for Hepatitis C virus ribonucleic acid (HCV-RNA).
- •If tested negative, subject can be included in the study. Subjects with
- •HCV-RNA positive shall be excluded from the study.
- •6. Subject had a 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 from the time of
- •Screening 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
- •10. Significant risk of suicidality at the Screening assessment based on the Investigator's judgment or, if appropriate, as indicated by a
- •response of yes within the last 12 months to question 4 or 5 in the
- •suicidal ideation section, or any response in the behavioral section of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Laboratory abnormalities:
- •11. Subject has laboratory abnormalities at Screening, including any of the following (Subjects are allowed to have 1 re-testing should the
- •Principal Investigator find the result incongruent with the subject's
- •medical history or hi
研究者
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