CTRI/2020/10/028392招募中3 期
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis - PERSEUS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •I 01. The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
- •Type of participant and disease characteristics:
- •I 02. The participant must have been diagnosed with PPMS in according with the 2017 revision of the McDonald diagnostic criteria
- •I 03. The participant must have an EDSS score at screening from 2.0 to 6.5 points, inclusive.
- •I 04. The participant must have, at screening, disease duration from the onset of MS symptoms of:
- •- <15 years in participants with EDSS scores at screening >5.0,
- •- <10 years in participants with EDSS scores at screening <=5.0
- •I 05. The participant must have positive CSF (isoelectric focusing evidence of oligoclonal bands and/or elevated IgG index) either during screening or previous historical assessment.
- •Supportive source documentation must be available.
- •I 06. Not applicable.
- •I 07. Male or female
- •Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A) Male participants
- •Not applicable
- •B) Female participants
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a woman of childbearing potential (WOCBP)
- •Is a WOCBP and agrees to use an acceptable contraceptive method as described in Appendix 4 of protocol during the intervention period.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) (Appendix 2 [Section 10.2] of protocol) before the first dose of study intervention.
- •If a urne test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •Requirements for pregnancy testing during and after study intervention are located in the schedule of activities (SoA; Section 1.3 of the protocol).
- •Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2 (Section 10.2 of the protocol).
- •The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy, if allowed by local regulations.
- •See Appendix 9 (Section 10.9) for country-specific contraception requirements.
- •Informed Consent
- •I 08. The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participantâ??s legally authorized representative (Appendix 1, Section 10.1.3).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •E 01. The participant has a history of infection or may be at risk for infection:
- •A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation) and/or antirejection therapy
- •E 02. The presence of psychiatric disturbance or substance abuse as evidenced by:
- •A history of any psychiatric disease, behavioral condition, or depression requiring hospitalization within 2 years prior to the Screening Visit
- •E 03. The following findings obtained during the screening visit considered in the Investigatorâ??s judgment to be clinically significant:
- •Any screening laboratory values outside normal limits.
- •Abnormal ECG
- •E 04. Conditions that may predispose the patient to excessive bleeding:
- •A bleeding disorder or known platelet dysfunction at any time prior to the Screening Visit.
- •A platelet count <150 000/μL at the Screening Visit.
- •The participant has had major surgery within 4 weeks prior to the Screening Visit, which could affect the participantâ??s safety or affect immune response (as judged by the Investigator) or has planned any elective major surgery during the study.
- •E 05. Conditions that would adversely affect participation in the study or make the primary efficacy endpoint non-evaluable:
- •A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist.
- •Prior/concomitant therapy
- •E 06. A requirement for concomitant treatment that could bias the primary evaluation, such as any of the following medications/treatments within the specified time frame before any randomization assessment (no wash out is required for interferon beta or glatiramer acetate treatments although use is not permitted on or after Day 1
- •E 07. The participant is receiving strong inducers or inhibitors of P450 3A (CYP3A) or CYP2C8 hepatic enzymes as listed in Section 6.5. of the protocol.
- •E 08. The participant is receiving anticoagulant/antiplatelet therapies, including:
- •Acetylsalicylic acid (aspirin)
- •Antiplatelet drugs (eg, clopidogrel)
- •E 09. The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- •Prior/concurrent clinical study experience
- •E 10. The participant was previously exposed to any BTK inhibitor, including SAR442168
- •E 11. The participant has taken other investigational drugs within 3 months or 5 half-lives, whichever is longer, before the screening visit.
- •E 12. The participant has a contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol
- •scheduled MRI
- •Other exclusions
- •E 13. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- •E 14. Any country-related specific regulation that would prevent the participant from entering the study. See Appen
研究者
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