Overview
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-10-31
2023-10-31
Target enrollment:
0
0
Participant gender:
All
All
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 PatientsPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
KalVista Pharmaceuticals, Ltd.
Criteria
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 these medicines
indicated for HAE: intravenous (iv) or sc plasma-derived C1 inhibitor (C1-INH), and/or
lanadelumab, 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 has had at least 2 documented HAE attacks within 3 months prior to
randomization.
- 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 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.
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors and inducers during
participation in the trial, starting within 5 half-lives of the Screening Visit.
- Inadequate organ function, including but not limited to:
1. Alanine aminotransferase (ALT) >2x upper limit of 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
- 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, 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.