CTIS2023-504418-30-00招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of MBS2320 in Patients With Idiopathic Pulmonary Fibrosis (IPF) - IST-07
Modern Biosciences Limited0 个研究点目标入组 306 人开始时间: 2023年6月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 306
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Participant must be 40 years or older at the time of signing the informed consent., 10. Has a life expectancy of at least 12 months (in the opinion of the investigator)., 11. According to the investigator’s best judgment, can comply with the requirements of the protocol, 2. Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmed by the investigator based on chest high-resolution computed tomography (hrCT) scan taken within, 3. Has an FVC =45% of predicted., 4. Has a DLCO corrected for hemoglobin =25% and =80% of predicted., 5. Minimum distance on 6MWT of 150 meters., 6. Has a FEV1/FVC ratio >0.70., 7. If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1 and during Screening and are predicted to remain stable during the course of the study. A combination of both pirfenidone plus nintedanib is not allowed. Where approved, patients not currently receiving treatment with pirfenidone or nintedanib therapy should have a valid reason: this includes contraindication to therapy (including concerns around DDI), previous treatment discontinued due to lack of response or tolerability, not meeting national or regional eligibility criteria for anti-fibrotic treatment, or patient choice., 8. Male and female participants using contraception in line with local regulations regarding the methods of contraception for those participating in clinical studies (Appendix 4)., 9. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •1. Emphysema =50% on hrCT or the extent of emphysema is greater than the extent of fibrosis according to the central reviewer’s assessment from the most recent hrCT or if reported by the local reviewer., 18. Has a known post bronchodilator (short acting beta agonist [SABA] – albuterol or salbutamol) increase in FEV1 of >10% and in FVC of >7.5%, 19. Use of strong CYP3A4 inhibitors/inducers within 30 days or 5 half-lives, whichever is longer, prior to baseline visit. See Appendix 6 for a full list of strong CYP3A4 inhibitors/inducers that are prohibited for concomitant use., 2. Any current malignancy or a history of malignancy within the previous 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ., 20. Use of uridine 5’-diphospho-glucuronosyltransferase (UGT)2B7 inhibitors within 30 days or 5 half-lives, whichever is longer, prior to baseline visit. See Appendix 6 for a full list of UGT2B7 inhibitors that are prohibited for concomitant use., 21. Systemically administered CA inhibitors within 30 days or 5 half-lives, whichever is longer, prior to baseline visit. See Appendix 6 for a full list of CA inhibitors that are prohibited for concomitant use., 22. A live virus vaccination within the 90 days prior to the baseline visit (1 year for Bacillus Calmette-Guerin vaccination) or intent to receive a live virus vaccination during the study or within 28 days after study completion, 23. Participation in another clinical study (including attending follow-up visits) or receipt of any investigational drug within a minimum of 90 days or 5 half-lives of the drug (whichever is longer) prior to the baseline visit., 24. Previously received MBS2320., 25. Current use of tobacco products and/or vaping., 26. Donated blood in the 90 days prior to screening., 10. Active infection that is clinically significant in the Investigator’s opinion, or any infection requiring hospitalization or treatment with intravenous antimicrobials =60 days of screening, or any infection requiring oral antimicrobial therapy =2 weeks of the baseline visit., 27. Prior GI surgeries or any GI procedures/conditions that may cause concerns with absorption of the study drug., 28. History of major surgery (requiring regional block or general anesthesia) within 3 months prior to screening or planned major surgery during the study., 29. Male participants who have not undergone a vasectomy and do not agree to use appropriate contraception (i.e., a condom with spermicidal foam/gel/film/cream/suppository) with their partners of childbearing potential or partners sterilized by tubal ligation, or who do not agree to use an additional highly effective method of contraception with their partners of childbearing potential., 3. Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study. Specific 12-lead ECG exclusion criteria are participants with QT corrected using Fridericia’s formula (QTcF) of >450 ms (males) or >460 ms (females) and participants with PR interval of >220 ms at screening (1 repeat assessment is allowed)., 30. Male participants who do not agree to refrain from donating sperm from the time of the first dose until 90 days after the final dosing occasion., 31. Female participants of childbearing potential who do not agree to use a highly effective method of birth cont
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