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Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

ConditionAcquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharvaris Netherlands B.V.

About this trial

This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of written informed consent

Male or female (sex at birth) aged ≥18 years

Diagnosis of AAE-C1INH

Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH

Disqualifiers

Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).

Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit

Any females who are pregnant, plan to become pregnant, or are currently breast-feeding

Abnormal hepatic function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deucrictibant

    Drug

    Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use

  • Placebo

    Drug

    Part 1: Placebo Comparator tablet for once daily oral use

  • Deucrictibant

    Drug

    Part 2: Deucrictibant 20 mg soft capsule oral use

  • Placebo

    Drug

    Part 2: Placebo Comparator soft capsule oral use

  • Deucrictibant

    Drug

    Part 3: Deucrictibant 20 mg soft capsule oral use

Treatment groups

32 Participants
are divided into 5 treatment groups
Group A: Part 1 - Arm 1 - ActiveExperimental treatment 1 intervention
Group B: Part 1 - Arm 2 - PlaceboPlacebo comparator 1 intervention
Group C: Part 2 - Arm 1Experimental treatment 2 interventions
Group D: Part 2 - Arm 2Experimental treatment 2 interventions
Group E: Part 3 - Open-labelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 (Prophylaxis, Double-blind Treatment Phase)

Time-normalized number of Investigator-confirmed AAE attacks during Treatment Phase

Time frame
12 weeks
2

Part 2 (On-demand, Double-blind Treatment Phase)

Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better"

Time frame
12 hours post-treatment
3

Part 3 (On-demand, Open-label Extension Treatment Phase)

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation

Time frame
Through study completion, an average of 36 weeks

Secondary outcomes

1

Part 1 (Prophylaxis, Double-blind Treatment Phase)

Proportion of participants who are AAE attack-free during Treatment Phase

Time frame
12 weeks
2

Part 1 (Prophylaxis, Double-blind Treatment Phase)

Time-normalized number of Investigator-confirmed AAE attacks treated with on-demand medication during Treatment Phase

Time frame
12 weeks
3

Part 1 (Prophylaxis, Double-blind Treatment Phase)

Time-normalized number of Investigator-confirmed moderate or severe AAE attacks during Treatment Phase

Time frame
12 weeks
4

Part 1 (Prophylaxis, Double-blind Treatment Phase)

Safety endpoints: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation

Time frame
12 weeks

Other outcomes

1

Part 3 (On-demand, Open-label Extension Treatment Phase)

Time to symptom relief, as PGI-C rating of at least "better"

Time frame
12 hours post-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharvaris Netherlands B.V.

Lead sponsor

Source ClinicalTrials.gov
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