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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Vaderis Therapeutics AG
Study ID
NCT07743671
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Engasertib — DRUG
    Engasertib will be administered as oral capsules.
  • Placebo — DRUG
    Placebo will be administered as oral capsules.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 14, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Engasertib 40 mg
    Participants will receive engasertib as an oral capsule QD for 28 weeks.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo as an oral capsule QD for 28 weeks.

Primary Outcome Measure

Total Number of Epistaxis Events Through Week 28 [ Time Frame: Day 1 through Week 28 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637
Kenneth Cohen, MD
[email protected]
773-702-4043
Innovative Hematology, Inc.,IndianapolisIndiana46260
Magdalena Lewandowska, MD
[email protected]
317-871-0011
Mayo ClinicRochesterMinnesota55905
Vivek N. Iyer, MD, MPH
[email protected]
507-284-2158
Washington University School of MedicineSt LouisMissouri63110
Murali Mohan Chakinala, MD
[email protected]
314-454-8764

Find similar trials in Chicago, IL

By research site
The University of Chicago Medical Center (UCMC)· Chicago, ILInnovative Hematology, Inc.· Indianapolis, INMayo Clinic· Rochester, MNWashington University School of Medicine· St Louis, MO

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