An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Last updated: February 17, 2026
Sponsor: KalVista Pharmaceuticals, Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Urticaria

Hereditary Angioedema

Allergy

Treatment

KVD900 300 mg

KVD900 600 mg

Clinical Study ID

NCT05505916
KVD900-302
  • Ages > 12
  • All Genders

Study Summary

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

Eligibility Criteria

Inclusion

Patients may roll over from KVD900-301.

Inclusion Criteria:

  1. Confirmed diagnosis of HAE type I or II at any time in the medical history

  2. Patient has had at least 2 documented HAE attacks within 3 months prior to theEnrollment Visit.

  3. If a patient is receiving long-term prophylactic treatment with one of theprotocol-allowed therapies, they must have been on a stable dose and regimen for atleast 3 months prior to the Enrollment Visit (except for danazol, which requires astable dose and regimen for at least 6 months prior to the Enrollment Visit).

  4. Male or female patients 12 years of age and older.

  5. Patients must meet the contraception requirements.

  6. Patients must be able to swallow trial tablets whole.

  7. Patients, as assessed by the Investigator, must be able to appropriately receive andstore IMP, and be able to read, understand, and complete the eDiary.

  8. Investigator believes that the patient is willing and able to adhere to all protocolrequirements.

  9. Patient provides signed informed consent or assent (when applicable). A parent orlegally authorized representative (LAR) must also provide signed informed consentwhen required.

Exclusion

Exclusion Criteria:

  1. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal ofconsent, or safety.

  2. Presence of any safety concerns that would preclude participation in the open-labeltrial as determined by the investigator.

  3. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III),idiopathic angioedema, or angioedema associated with urticaria.

  4. A clinically significant history of poor response to bradykinin receptor 2 (BR2)blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the managementof HAE, in the opinion of the Investigator.

  5. Use of attenuated androgens other than danazol (e.g., stanozolol, oxandrolone,methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid)within 28 days prior to the Enrollment Visit.

  6. Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to theEnrollment Visit.

  7. Any estrogen-containing medications with systemic absorption (such as oralcontraceptives including ethinylestradiol or hormonal replacement therapy) within 7days prior to the Enrollment Visit.

  8. Inadequate organ function, including but not limited to:

  9. Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN)

  10. Aspartate aminotransferase (AST) >2x ULN

  11. Bilirubin direct >1.25x ULN

  12. International Normalized Ratio (INR) >1.2

  13. Clinically significant hepatic impairment defined as a Child-Pugh B or C

  14. Any clinically significant comorbidity or systemic dysfunction, which in the opinionof the Investigator, would jeopardize the safety of the patient by participating inthe trial.

  15. History of substance abuse or dependence that would interfere with the completion ofthe trial, as determined by the Investigator.

  16. Known hypersensitivity to KVD900 or to any of the excipients.

  17. Participation in any gene therapy treatment or trial for HAE.

  18. Participation in any interventional investigational clinical trial, including aninvestigational COVID-19 vaccine trial, within 4 weeks of the last dosing ofinvestigational drug prior to the Enrollment Visit.

  19. Any pregnant or breastfeeding patient.

Study Design

Total Participants: 145
Treatment Group(s): 2
Primary Treatment: KVD900 300 mg
Phase: 3
Study Start date:
October 24, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • KalVista Investigative Site

    Campbelltown, 2560
    Australia

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    Campbelltown 2172586, 2560
    Australia

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    Wein, 1090
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    Spokane, Washington 99204
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  • KalVista Investigative Site

    Spokane 5811696, Washington 5815135 99204
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