EUCTR2020-000955-11-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 Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 472
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
- •XML File Identifier: 5Zey1YQY4+dw3ckORaBr8gAVNvA=
- •criteria, APPENDIX 1) for at least 6 months before the first
- •administration of the study agent and has active PsA confirmed at
- •Screening and Baseline.
- •4. Subject has = 3 tender and = 3 swollen joints at Screening and
- •Note: Dactylitis of a digit counts as one joint for the purpose of joint
- •count for eligibility assessment. However, individual joints will be
- •counted for efficacy assessments of Tender joint counts (TJC) or Swollen
- •joint counts (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 prior exposure to anti-tumor necrosis factor (anti-
- •TNF) agent(s) 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. Subjects receiving non-drug therapy (including but not limited to
- •physical therapy, massage, diet, exercise, emollients, and joint taping)
- •must be stable for the 4week period prior to IMP initiation through to
- •the end of double blind 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 diseases),
- 另有 6 项未显示
排除标准
- •1.Subject has a planned surgical intervention between Baseline and Week 52 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 IV 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
- •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
- •5. Subject has a known history of infection with hepatitis B, hepatitis C, or HIV
- •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 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 years
- •10. Significant risk of suicidality at the Screening assessment
- •11. Subject has laboratory abnormalities at Screening
- •12. Subject has used any of the following within 28 days of IMP initiation: high potency opioid analgesics, recreational marijuana, medical marijuana, and CBD; sulfasalazine; hydroxychloroquine; systemically administered calcineurin inhibitors; azathioprine; topical and parenteral corticosteroids including intramuscular or intra-articular administration (ophthalmic, intra-nasal, inhaled corticosteroids, and low potency topical corticosteroid applied to psoriatic lesions in the face and groins are permitted); topical coal tar; live vaccines (inactivated flu vaccine injection allowed, but not live flu nasal spray vaccine); has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP
- •13. Use of commercially available or investigational biologic therapies for PsO and/or PsA as follows: use of etanercept within 4 weeks, infliximab within 8 weeks, and all other anti-TNF therapy within 3 months prior to IMP initiation; prior use of B-cell depleting agent or T-cell inhibitor within 12 months of Screening; use of any other investigational or commercially available biologic therapies for PsO and/or PsA within 3 months or 5 half-lives (whichever is longer) prior to IMP initiation; use of apremilast or other approved or investigational medications for the treatment of PsA which are not identified as permitted therapies within 5 half-lives or 30 days (whichever is longer) prior to IMP initiation; any prior use of secukinumab, ustekinumab, ixekizumab, brodalumab, or any drugs targeting interleukin (IL)-17, IL-23, or the IL-12/IL-23-shared p40 molecule
- •14. Subject has known sensitivity to any of the products or any excipients to be administered during dosing (histidine, polysorbate 80, and sucrose)
- •15. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856EUCTR2018-003985-15-PTArena Pharmaceuticals Inc.433
进行中（未招募）
1 期
A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisEUCTR2019-000968-18-CZCB Biopharma SR240
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyHomologous recombination deficiency advanced ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000952-11-ITTESARO, INCORPORATED733
进行中（未招募）
1 期
A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)EUCTR2016-004148-13-PTGilead Sciences, Inc.800
招募中
1 期
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung Cancerung Cancer, Non-Small CellMedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-508443-40-00Glaxosmithkline Research & Development Limited644