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)
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|ClinicalTrials.gov Identifier: NCT05259917|
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : April 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hereditary Angioedema||Drug: Placebo Drug: KVD900 600 mg Drug: KVD900 300 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||February 23, 2022|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
|Placebo Comparator: Placebo||
Placebo to KVD900 Tablet
|Experimental: KVD900 600 mg||
Drug: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
|Experimental: KVD900 300 mg||
Drug: KVD900 300 mg
KVD900 Tablet 300 mg (1 x 300 mg)
- Time to beginning of symptom relief Patient Global Impression of Change (PGI-C) [ Time Frame: within 12 hours of the first investigational medicinal product (IMP) administration. ]Time to beginning of symptom relief defined as at least "a little better" (2 time points in a row)
- Time to first incidence of decrease from baseline Patient Global Impression of Severity (PGI-S) [ Time Frame: within 12 hours of the first IMP administration. ]
- Time to HAE attack resolution (PGI-S) [ Time Frame: within 24 hours of the first IMP administration. ]Time to HAE attack resolution defined as "none"
- Proportion of attacks with beginning of symptom relief (PGI-C) [ Time Frame: within 4 hours and within 12 hours of the first IMP administration. ]Proportion of attacks with beginning of symptom relief defined as at least "a little better" (2 time points in a row)
- Time to at least "better" (PGI-C) [ Time Frame: within 12 hours of the first IMP administration. ]
- Time to first incidence of decrease from baseline (PGI-S) [ Time Frame: within 24 hours of the first IMP administration. ]
- Time to at least a 50% decrease from baseline (3 time points in a row) Composite Visual Analogue Scale (VAS) [ Time Frame: within 12 hours and within 24 hours of the first IMP administration ]
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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|
- 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.
- has had at least 2 documented HAE attacks within 3 months; 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.
- 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.
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): NCT05259917
|Contact: KalVista Pharmaceuticals||1 (857) firstname.lastname@example.org|
|Study Director:||Study Director||KalVista Pharmaceuticals, Ltd.|
|Responsible Party:||KalVista Pharmaceuticals, Ltd.|
|Other Study ID Numbers:||
|First Posted:||March 2, 2022 Key Record Dates|
|Last Update Posted:||April 28, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Skin Diseases, Vascular
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes