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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

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 attacks in adolescent and adult Patients

Key facts

Study ID: NCT05259917
Run by: KalVista Pharmaceuticals, Ltd.
People needed: 136
Starts: 2022-02-22
Expected to finish: 2023-12-31
Last updated by the study team: 2025-05-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

KalVista Investigative Site — Scottsdale, Arizona, United States
KalVista Investigative Site — Little Rock, Arkansas, United States
KalVista Investigative Site — San Diego, California, United States
KalVista Investigative Site — San Diego, California, United States
KalVista Investigative Site — Santa Monica, California, United States
KalVista Investigative Site — Centennial, Colorado, United States
KalVista Investigative Site — Colorado Springs, Colorado, United States
KalVista Investigative Site — Tampa, Florida, United States
KalVista Investigative Site — Chicago, Illinois, United States
KalVista Investigative Site — Overland Park, Kansas, United States
KalVista Investigative Site — Louisville, Kentucky, United States
KalVista Investigative Site — Chevy Chase, Maryland, United States
KalVista Investigative Site — Plymouth, Minnesota, United States
KalVista Investigative Site — St Louis, Missouri, United States
KalVista Investigative Site — New York, New York, United States
KalVista Investigative Site — Charlotte, North Carolina, United States
KalVista Investigative Site — Toledo, Ohio, United States
KalVista Investigative Site — Hershey, Pennsylvania, United States
KalVista Investigative Site — Dallas, Texas, United States
KalVista Investigative Site — Layton, Utah, United States
KalVista Investigative Site — Spokane, Washington, United States
KalVista Investigative Site — Campbelltown, New South Wales, Australia
KalVista Investigative Site — Sofia, Bulgaria
KalVista Investigative Site — Toronto, Ontario, Canada
KalVista Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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