A Trial to Assess the Efficacy and Safety of Engasertib in Participants With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)
NCT07743671 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-08-04
Summary
The primary objective of this trial is to assess the efficacy of engasertib 40 mg once daily (QD) in reducing the frequency of epistaxis compared to placebo QD during 28 weeks of double-blind treatment in participants with moderate to severe HHT.
Conditions
- Hereditary Hemorrhagic Telangiectasia
Interventions
- DRUG
-
Engasertib
Engasertib will be administered as oral capsules.
- DRUG
-
Placebo will be administered as oral capsules.
Sponsors & Collaborators
-
Vaderis Therapeutics AG
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Drug
- Yes
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