2024-520218-23-00
招募中
3 期
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.
Inhibikase Therapeutics Inc.37 个研究点 分布在 12 个国家目标入组 88 人开始时间: 2026年6月1日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Inhibikase Therapeutics Inc.
- 入组人数
- 88
- 试验地点
- 37
- 主要终点
- 2. Part B: Change from baseline in 6MWD at Week 24
概览
简要总结
To evaluate the efficacy and safety of IKT-001 treatment versus placebo in addition to background PAH therapy in adults with WHO Group 1 PAH.
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B
- 盲法
- Double (Monitor, Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •NT-proBNP >300 ng/L during screening.
- •If male with a pregnant partner or a partner who is a WOCBP, must agree to use a condom from the time of first dose through 7 days after the last dose of study drug.
- •If female and a WOCBP as defined in Section 7.2.1, must meet all the requirements below: • Agrees to use a contraceptive method that is highly effective (defined as having a failure rate of <1% per year as described in Section 7.2.2) from the time of first dose through 7 days after the last dose of study drug AND • Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction from at least 14 days prior to dosing through the end of the study AND • Has negative pregnancy tests at screening and before the administration of the first dose of study drug
- •Documented diagnosis of WHO PAH Group 1 in any of the following subtypes: • Idiopathic PAH • Heritable PAH • Drug/toxin-induced PAH • PAH associated with CTD • PAH associated with simple, congenital systemic-to-pulmonary shunts ≥1 year following repair • HIV-associated PAH
- •Men and women 18 and 75 years of age (inclusive) at the time of signing the ICF.
- •Must have a BMI of ≥18.5 kg/m² and ≤35.0 kg/m² during screening.
- •Baseline RHC performed during the screening period documenting a PVR of ≥400 dyn·sec·cm⁻⁵, a PCWP or left ventricular end-diastolic pressure of ≤15 mmHg, and an mPAP of >20 mmHg.
- •On stable doses of background PAH therapy (≤3 PAH specific medications) including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days before screening. Current use of sotatercept is not permitted in this study.
- •Anticipated to be able to perform the 6MWT according to American Thoracic Society Guidelines for the duration of the study.
排除标准
- •Diagnosis of PAH WHO Groups 2, 3, 4, or
- •Untreated or inadequately treated obstructive sleep apnea, in the opinion of the investigator.
- •Acute or chronic hepatitis B or C infection, defined as: • Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test • HCV: a positive hepatitis C antibody test with detectable HCV RNA. Participants with a positive hepatitis C antibody test, but no detectable HCV RNA who completed treatment with direct-acting antivirals may be considered after discussion with the medical monitor.
- •Diagnosis of the following PAH Group 1 subtypes: • PAH associated with portal hypertension • Schistosomiasis-associated PAH • Pulmonary veno-occlusive disease
- •History of or currently diagnosed with a bleeding disorder, including but not limited to hemophilia, von Willebrand disease, thrombocytopenia, or significant bleeding history defined as any bleeding event requiring medical intervention (eg, transfusion).
- •Received treatment with any of the following excluded medications: • Currently receiving strong CYP3A inducers or CYP3A inhibitors (except for topical administration) • Currently receiving or anticipated need to receive any anticoagulant (eg, heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors, with the exception of short-term, periprocedural use of anticoagulants (eg, heparin) administered during RHC, as deemed appropriate by the investigator) • Currently using sotatercept (Note: participants who previously received sotatercept may be considered if the last dose administered was >6 months before screening, participant had no significant bleeding events while on sotatercept, and the case is approved by the medical monitor prior to study entry)
- •Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of screening or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
- •History of atrial septostomy within 180 days of screening.
- •Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days of screening.
- •Previous randomization into this or another IKT-001 study.
研究组 & 干预措施
IkT-001Pro
Test
干预措施: IkT-001Pro (Drug)
Placebo to match 100 mg IKT-001 tablets
Placebo
干预措施: Placebo to match 100 mg IKT-001 tablets (Drug)
结局指标
主要结局
2. Part B: Change from baseline in 6MWD at Week 24
2. Part B: Change from baseline in 6MWD at Week 24
1. Part A: Change from baseline in PVR at Week 24
1. Part A: Change from baseline in PVR at Week 24
次要结局
- 1. Part A only: Change from baseline in 6MWD at Week 24
- 2. Part B only: Change from baseline in PVR at Week 24
- 3. Change from baseline in NT-proBNP concentrations at Week 24
- 4. Time to all-cause death or the first occurrence of a clinical worsening event (time to clinical worsening)
- 5. Proportion of participants who improve from baseline in WHO FC or maintain WHO FC II from baseline to Week 24
- 6. Proportion of participants who maintain low or intermediate-low risk score or achieve a lower ESC/ERS 4 strata risk score at Week 24
- 7. Change from baseline in HRQoL / EmPHasis-10 total score at Week 24
研究者
Chad Orevillo
Scientific
Inhibikase Therapeutics Inc.
研究点 (37)
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