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RECRUITING
NCT07743671
PHASE3

A Trial to Assess the Efficacy and Safety of Engasertib in Participants With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)

Sponsor: Vaderis Therapeutics AG

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-09

Completion Date

2028-06

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DRUG

Engasertib

Engasertib will be administered as oral capsules.

DRUG

Placebo

Placebo will be administered as oral capsules.

Locations (4)

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

Innovative Hematology, Inc.,

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States