Status:
COMPLETED
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
Lead Sponsor:
KalVista Pharmaceuticals, Ltd.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema atta...
Eligibility Criteria
Inclusion
- Male or female patients 12 years of age and older.
- Confirmed diagnosis of HAE type I or II at any time in the medical history.
- Patient has access to and ability to use conventional on-demand treatment for HAE attacks.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must be on a stable dose and regimen for at least 3 months prior to the Screening Visit (except for danazol, which requires a stable dose and regimen for 6 months prior to the Screening Visit). Patient must be willing to remain on a stable dose and regimen for the duration of the trial.
- Patient's last dose of attenuated androgens other than danazol was at least 28 days prior to randomization.
- Patient:
- has had at least 2 documented HAE attacks within 3 months prior to screening or randomization; or
- is a completer of the KVD824-201 trial within 3 months prior to randomization and meets all other entry criteria to enroll in KVD900-301
- Patients must meet the contraception requirements.
- Patients must be able to swallow trial tablets whole.
- Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the electronic diary (eDiary).
- Investigator believes that the patient is willing and able to adhere to all protocol requirements.
- 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
- 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.
- 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.
- Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
- Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
- Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
- Inadequate organ function, including but not limited to:
- Alanine aminotransferase (ALT) \>2x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) \>2x ULN
- Bilirubin direct \>1.25x ULN
- International normalized ratio (INR) \>1.2
- Clinically significant hepatic impairment defined as a Child-Pugh B or C
- 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.
- History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
- Known hypersensitivity to KVD900 or placebo or to any of the excipients.
- Prior participation in trial KVD900-201.
- Participation in any gene therapy treatment or trial for HAE.
- Participation in any interventional investigational clinical trial (with the exception of KVD824-201), including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to screening.
- Any pregnant or breastfeeding patient.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05259917
Start Date
February 22 2022
End Date
December 31 2023
Last Update
May 2 2025
Active Locations (66)
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1
KalVista Investigative Site
Birmingham, Alabama, United States, 35209
2
KalVista Investigative Site
Scottsdale, Arizona, United States, 85251
3
KalVista Investigative Site
Little Rock, Arkansas, United States, 72205
4
KalVista Investigative Site
San Diego, California, United States, 92122