Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients

Part of paid clinical trials in Wheaton, Maryland.

Sponsor
Institute for Asthma and Allergy
Study ID
NCT07046806
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Angioedema
  • Bradykinin-mediated Angioedema
  • C1 Inhibitor Deficiency
  • Hereditary Angioedema (HAE)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Deucrictibant XR tablet — DRUG
    Deucrictibant 40 mg XR tablet for prophylaxis
  • Placebo comparator to XR tablet — DRUG
    Placebo comparator to deucrictibant 40 mg XR tablet, prophylaxis
  • Deucrictibant 20 mg capsule — DRUG
    Deucrictibant active drug for on-demand treatment of angioedma attacks
  • Placebo comparator to 20 mg capsule — DRUG
    Placebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks

Study Details

To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.

Key Dates

Start date
Mar 10, 2025
Status verified
Jun 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Deucrictibant XR tablet, 40 mg, prophylaxis
    Deucrictibant XR tablet, 40 mg, QD, oral use for 12 weeks
  • Placebo Comparator: Placebo to deucrictibant XR tablet, 40 mg, prophylaxis
    Placebo tablets, 40 mg equivalent, QD, oral use for 12 weeks
  • Experimental: On-demand deucrictibant 20 capsule, oral use
    Single 20 capsule orally for treatment of on-demand angioedema attack, for up to 16 weeks
  • Placebo Comparator: Placebo comparator to on-demand deucrictibant 20 capsule, oral use
    Placebo capsules for treatment of on-demand angioedema attacks, for up to 16 weeks

Primary Outcome Measure

Part-1: Incidence and quality of HAE attacks comparing active versus placebo arms. [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute For Asthma & AllergyWheatonMaryland20902
Henry LI, MD, PhD
[email protected]
301-962-5800

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