EUCTR2022-000498-15-AT招募中1 期
A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients with Idiopathic Pulmonary Fibrosis - A Phase 2 study of RXC007 in patients with IPF
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
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
- 性别
- All
入选标准
- •1. Ability to provide signed and dated informed consent.
- •2. Aged =40 to 80 years at the time of signing the informed consent.
- •3. Diagnosis of IPF within 5 years of Screening based on the modified IPF guidelines for diagnosis and management of IPF and confirmed on independent central imaging review.
- •4. Combination of HRCT pattern, as assessed by central reviewers, consistent with diagnosis of IPF.
- •5. FVC % predicted =50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomisation, as determined by the Investigator.
- •6. DLco (Hb-adjusted) at screening =30%.
- •7. In the main study, participants receiving treatment for IPF with nintedanib or pirfenidone are allowed if on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to Screening and during Screening.
- •8. In patients who are not on any treatment for IPF but have previously received nintedanib or pirfenidone, there needs to be a washout period =4 weeks prior to Screening.
- •9. No clinically significant history of previous allergy/ sensitivity to RXC007 or any of the excipients contained within the Investigational Medicinal Product (IMP).
- •10. Blood cell parameters within the following limits:
- •o Haemoglobin >10 g/dL (>100 g/L)
- •o WBC count >3.00 × 10^3/µL (>3.00 x 10^9/L)
- •o Neutrophils >1.50 × 10^3/µL (>1.50 x 10^9/L)
- •o Platelets >80 × 10^3/µL (>80 x 10^9/L)
- •11. Alanine transaminase (ALT) and aspartate transaminase (AST) <2x upper limit of normal (ULN). Total bilirubin <1.5 X ULN.
- •12. Negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- •13. No clinically significant abnormalities in 12-lead ECG determined within 28 days before first dose of IMP including a QTcF interval >470 ms.
- •14. No clinically significant abnormalities, in the opinion of the investigator, in vital signs (e.g., blood pressure, pulse rate, respiration rate, oral temperature) within 28 days before first dose of IMP.
- •15. Patients must be willing to comply with institutional COVID-19 testing policy.
- •16. Female patients must be surgically sterile, (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), post-menopausal (minimum 1 year without menses), or agree to use highly effective contraception with all male sexual partners from the time of signing the Patient Informed Consent Document (PICD) until 6 months after the last dose of study medication: combined (oestrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only contraception associated with the inhibition of ovulation (oral, implant, or injection); intrauterine device (IUD), Intrauterine system (IUS) (e.g., Mirena), or bilateral tubal occlusion; vasectomised partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); or abstinence.*
- •*Defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- •Note: hormonal contraception should be supplemented by use of a condom/ other barrier method.
- •17. Men must agree to use a condom (with spermicide) during the study, and for 6 months after the last dose of study drug, with all sexual
排除标准
- •1. Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication.
- •2. FEV1/FVC ratio <0.7 at Screening, pre-bronchodilator use.
- •3. Lower respiratory tract infection requiring antibiotics within 4 weeks of Screening or during Screening.
- •4. The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans.
- •5. Need for continuous oxygen supplementation, defined as >15 hours/day.
- •6. Acute IPF exacerbation within 6 months of Screening or during Screening.
- •7. Patients who have any history of an active (requiring treatment) malignancy within 2 years of screening (except any in-situ carcinoma, non-melanoma skin carcinoma, and early prostate cancer with a normal prostate-specific antigen [PSA]).
- •8. Significant cardiac disease (e.g., New York Heart Association Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias; or pulmonary hypertension requiring pharmacologic treatment).
- •9. Clinical diagnosis of any connective-tissue disease (including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator applying the recent ERS/ATS research statement. Note: Serological testing is not needed if not clinically indicated.
- •10. Creatinine clearance <60 mL/min according to Cockcroft Gault equation.
- •11. A clinically significant history of GI disorder likely to influence IMP absorption.
- •12. A clinically significant history of infection in the last 3 months.
- •13. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction which, in the opinion of the investigator, would make the patient unsuitable for inclusion or unable to complete the study.
- •14. A clinically significant history of drug or alcohol abuse within the past 3 months prior to Screening.
- •15. Disease other than IPF with a life expectancy of less than 12 weeks.
- •16. Inability to communicate well with the Investigators (i.e., language problem, poor mental development, or impaired cerebral function).
- •17. Participation in a New chemical entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer.
- •18. Female who is pregnant or breastfeeding.
- •19. Patients who are currently receiving prohibited medications and are unable to stop.
- •20. Patients who are currently receiving steroids or anticoagulants (anti-platelet agents are permitted) and are unable to stop.
- •21. Participants who have received a COVID-19 vaccine injection within 72 hours prior to the first dose of IMP.
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