12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

Last updated: November 3, 2025
Sponsor: BioCryst Pharmaceuticals
Overall Status: Completed

Phase

2/3

Condition

Allergy

Urticaria

Hives (Urticaria)

Treatment

Placebo

BCX4161

Clinical Study ID

NCT02303626
BCX4161-301
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. A clinical diagnosis of HAE type I or II

  2. Documented HAE attacks within a defined calendar period; in the absence ofdocumented HAE attacks, participants will be required to enter a run-in period todocument attacks

  3. Access to acute attack medications

  4. Sexually active women of child-bearing potential and sexually active men mustutilize highly effective contraception

Exclusion

Key Exclusion Criteria:

  1. Women who are pregnant or breast-feeding

  2. Any clinical condition or medical history that would interfere with the subject'ssafety or ability to participate in the study

  3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks

  4. Current participation in any other investigational drug study or within the last 30days

  5. History of or current alcohol or drug abuse

  6. Infection with hepatitis B, hepatitis C or HIV

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
December 17, 2014
Estimated Completion Date:
January 31, 2016

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    Leuven,
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  • Leuven 2792482,
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    Ottawa,
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    Grenoble,
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    Lille,
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    Boston, Massachusetts 02114
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    Charlotte, North Carolina 28277
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    Cincinnati, Ohio 45267
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    Lake Oswego, Oregon 97035
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