A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels 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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    114
  • sponsor
    KalVista Pharmaceuticals, Ltd.
Updated on 21 September 2022
angioedema
c1 inhibitor (human)

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 attacks in adolescent and adult Patients

Details
Condition Hereditary Angioedema
Treatment Placebo, KVD900 600 mg, KVD900 300 mg
Clinical Study IdentifierNCT05259917
SponsorKalVista Pharmaceuticals, Ltd.
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 and be willing to remain on a stable dose and regimen for the duration of the trial
Patient's last dose of attenuated androgens was at least 28 days prior to randomization
Patient
Patients must meet the contraception requirements
has had at least 2 documented HAE attacks within 3 months; or
Patients must be able to swallow trial tablets whole
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, 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 Criteria

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
Inadequate organ function, including but not limited to
Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
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
Any pregnant or breastfeeding patient
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
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