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

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ClinicalTrials.gov Identifier: NCT05505916
Recruitment Status : Recruiting
First Posted : August 18, 2022
Last Update Posted : October 30, 2023
Sponsor:
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: KVD900 600 mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II
Actual Study Start Date : October 24, 2022
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: KVD900 600 mg Drug: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients with at least one Adverse Event (AE) in adolescent and adult patients with HAE type I or II who have taken at least one dose of Investigational medicinal product (IMP). [ Time Frame: AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient. ]

Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGI-C). [ Time Frame: within 12 hours of initial dose of IMP administration. ]
    time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row)

  2. Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline [ Time Frame: within 12 hours of initial dose of IMP administration. ]
  3. PGI-S: time to HAE attack resolution [ Time Frame: within 24 hours of initial dose of IMP administration. ]
    PGI-S: time to HAE attack resolution, defines as ''none''


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 the Enrollment Visit.
  3. If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable 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 and store 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 protocol requirements.
  9. Patient provides signed informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required.

Exclusion Criteria:

  1. Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
  2. Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
  3. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor 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 management of 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 the Enrollment Visit.
  7. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit.

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

    1. Alanine aminotransferase (ALT) >2x Upper Limit Normal (ULN)
    2. Aspartate aminotransferase (AST) >2x ULN
    3. Bilirubin direct >1.25x ULN
    4. International Normalized Ratio (INR) >1.2
    5. Clinically significant hepatic impairment defined as a Child-Pugh B or C
  9. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
  10. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
  11. Known hypersensitivity to KVD900 or to any of the excipients.
  12. Participation in any gene therapy treatment or trial for HAE.
  13. Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to the Enrollment Visit.
  14. Any pregnant or breastfeeding patient.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05505916


Contacts
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Contact: KalVista Pharmaceuticals 1 (857) 999-0075 clinicalstudies@kalvista.com

Locations
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Sponsors and Collaborators
KalVista Pharmaceuticals, Ltd.
Investigators
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Study Director: Study Director KalVista Pharmaceuticals, Ltd.
More Information
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Responsible Party: KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT05505916    
Other Study ID Numbers: KVD900-302
First Posted: August 18, 2022    Key Record Dates
Last Update Posted: October 30, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared until all global regulatory filings are complete.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KalVista Pharmaceuticals, Ltd.:
KONFIDENT-S
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes