DIAG723 in Adults With HHT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of DIAG723, a bispecific antibody targeting ALK-1 and BMPRII, in adults with HHT. The study has three sequential parts: Part A explores single ascending doses to establish safety and PK; Part B uses multiple 13-week doses to assess safety and early efficacy in HHT symptoms; Part C adds patients with HHT and pre-existing pulmonary arterial hypertension to evaluate safety and exploratory clinical effects. Participants are randomized to receive DIAG723 or placebo within each part, with inpatient monitoring after dosing and outpatient follow-up. The study aims to determine initial dosing signals and potential therapeutic activity in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients ≥18 years with a clinical or genetic diagnosis of HHT
* Adequate hepatic and renal function
* Part B: Epistaxis and anemia or transfusion/iron history
* Part C: HHT with documented pre-capillary pulmonary arterial hypertension

Exclusion Criteria:

* Active or recent systemic infection
* Recent thromboembolic events
* Use of anti-angiogenic drugs within 6 weeks
* Pregnancy or lactation
* Recent participation in another investigational study

Where it's running

• Diagonal Investigational Site
  Randwick, New South Wales, Australia Recruiting
• Diagonal Investigational Site
  East Melbourne, Victoria, Australia Recruiting
• Diagonal Investigational Site
  Grafton, Auckland, New Zealand Recruiting
• Diagonal Investigational Site
  Camperdown, New South Wales, Australia Not yet recruiting
• Diagonal Investigational Site
  Herston, Queensland, Australia Not yet recruiting
• Diagonal Investigational Site
  Herston, Queensland, Australia Withdrawn

Study contacts

• Study coordinator: Diagonal Therapeutics
• Email: clinicalinfo@diagonaltx.com
• Phone: 339-233-4291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.