Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Inclusion Criteria:

1. Provision of written informed consent/assent.

2. Male or female, aged ≥12 to ≤75 years at the time of providing written informedconsent/assent.

3. Diagnosis of HAE-1/2.

4. History of at least 2 HAE attacks in the last 3 months before screening.

5. Experience with using standard-of-care treatment to effectively manage on-demandtreatment for HAE attacks.

6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol,anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose andregimen and intend to remain on the same dose for 6 months before screening and theduration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.

7. Capable of recording, without assistance, electronic HAE diary and ePRO data usingan electronic device.

8. For adolescent participants aged ≥12 and <18 years of age: body weight ≥40 kg.

9. Female participants of childbearing potential must agree to the protocol specifiedpregnancy testing and contraception methods.

Exclusion Criteria:

1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.

2. Any diagnosis of angioedema other than HAE-1/2.

3. Any clinically significant comorbidity or systemic dysfunction that would interferewith the participant's safety or ability to participate in the study.

4. Use of attenuated androgens for short-term prophylaxis within 2 weeks beforescreening.

5. Abnormal hepatic function.

6. Abnormal renal function (eGFR <60 ml/min/1.73 m2).

7. History of alcohol or drug abuse within the previous year, or current evidence ofsubstance dependence or abuse.

8. Has received prior on-demand HAE treatment with deucrictibant.

9. Currently participating in any other investigational drug study or receiving otherinvestigational treatment within the last 30 days, or within 5 half-lives (whicheveris longer) of the time of randomization.

10. Prior gene therapy for any indication at any time.

11. Use of concomitant medications with systemic absorption that are strong inhibitorsof CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5half-lives (whichever is longer) of the time of randomization.

12. Known hypersensitivity to study drug or any of the excipients of study drug.