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Assess Safety and Efficacy of VAD044 in HHT Patients

NCT05406362 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-17

No results posted yet for this study

Summary

Part I: The purpose of this Phase 1b proof of concept study, randomised, placebo controlled, double blind, multicentre study is to asssess safety and efficacy of 2 doses of VAD044 in adult HHT patients.

Part II: The purpose of this open-label extension following the completion of the randomised double blind treatment and follow-up period (Part I of the study) is to assess the long-term safetty, tolerability and efficacy of VAD044 in adult HHT patients.

Conditions

  • Hereditary Hemorrhagic Telangiectasia (HHT)

Interventions

DRUG

VAD044 Part I

capsules to be taken once daily for 12 weeks

DRUG

VAD044 Part II

capsules to be taken once daily for 36 months

Sponsors & Collaborators

  • Vaderis Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Damien Picard · Vaderis Therapeutics AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406362 on ClinicalTrials.gov