A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II

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ClinicalTrials.gov Identifier: NCT04208412

Recruitment Status : Completed

First Posted : December 23, 2019

Last Update Posted : January 6, 2021

Sponsor:

Information provided by (Responsible Party):

KalVista Pharmaceuticals, Ltd.

Study Description

Brief Summary:

This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.

Condition or disease	Intervention/treatment	Phase
Hereditary Angioedema	Drug: KVD900 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	68 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
Actual Study Start Date :	July 2, 2019
Actual Primary Completion Date :	December 8, 2020
Actual Study Completion Date :	December 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hereditary angioedema

Genetic and Rare Diseases Information Center resources: Hereditary Angioedema Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: KVD900	Drug: KVD900 KVD900 tablet
Placebo Comparator: Placebo	Drug: Placebo Placebo to KVD900 Tablet

Outcome Measures

Primary Outcome Measures :

Time to use of conventional attack treatment [ Time Frame: 12 hours ]

Secondary Outcome Measures :

Proportion of hereditary angioedema (HAE) attacks that (1) worsen by one level or more from baseline or (2) use conventional attack treatment within 12 hours of study drug on the Patient Global Impression of Severity (PGI-S) [ Time Frame: 12 hours ]
Time to (1) worsening by one level or more from baseline, or (2) use of conventional attack treatment, whichever comes first within 12 hours of study drug on the Patient Global Impression of Severity (PGI-S) [ Time Frame: 12 hours ]
Time to symptom relief within 12 hours of study drug on the Patient Global Impression of Change (PGI-C) [ Time Frame: 12 hours ]
Visual Analogue Scale (VAS): Time to symptom relief within 12 hours of study drug [ Time Frame: 12 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female adult subjects 18 years of age and older.
Confirmed diagnosis of HAE type I or II at anytime in the medical history
At least 3 documented HAE attacks in the past 93 days, as supported by medical history.
Access to and ability to use conventional attack treatment for attacks of HAE
Adequate organ functions
Females of childbearing potential must agree to use highly effective birth control from the Screening visit until the end of the trial follow-up procedures.
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months, do not require contraception during the study
Males with female partners of childbearing potential must agree to be abstinent or else use a highly effective method of birth control as defined in inclusion 6 from the Screening visit until the end of the trial follow-up procedures
Provide signed informed consent and are willing and capable of complying with study requirements and procedures

Exclusion Criteria:

Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor (C1-INH) deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria
Current use of C1INH, androgens, or tranexamic acid for HAE prophylaxis
Use of angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 93 days prior to initial study treatment.
Use of androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) or antifibrinolytics within 30 days prior to initial study treatment.
Use of lanadelumab within 10 weeks prior to initial study treatment.
Use of strong CYP3A4/CYP2C9 inhibitors and inducers during participation in the trial
Clinically significant abnormal ECG at Visit 1 and pre-dose at Visit 2. This includes, but is not limited to, a QT interval by Fredericia, QTcF > 470 msec (for women) or > 450 msec (for men), a PR > 220 msec or ventricular and/or atrial premature contractions that are more frequent than occasional and/or occur as couplets or higher in grouping
Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
Any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disease or disorder which, in the opinion of the Investigator, would jeopardize the safety of the subject by taking part in the trial
History of substance abuse or dependence that would interfere with the completion of the study, as determined by the Investigator
Known lactose allergy or intolerance
Known hypersensitivity to KVD900 or placebo or to any of the excipients
Participation in an interventional investigational clinical study within 93 days or within 5 half-lives of the last dosing of investigational drug (whichever is longer) prior to initial study treatment
Any pregnant or breast-feeding subject

Contacts and Locations

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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): NCT04208412

Locations

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United States, Arizona
KalVista Investigative Site
Scottsdale, Arizona, United States, 85251
United States, Colorado
KalVista Investigative Site
Centennial, Colorado, United States, 80112
United States, Maryland
KalVista Investigative Site
Chevy Chase, Maryland, United States, 20815
United States, Ohio
KalVista Investigative Site
Cincinnati, Ohio, United States, 45231
United States, Texas
KalVista Investigative Site
Dallas, Texas, United States, 75231
United States, Washington
KalVista Investigative Site
Spokane, Washington, United States, 99204
Austria
KalVista Investigative Site
Wien, Austria
Czechia
KalVista Investigative Site
Brno, Czechia
KalVista Investigative Site
Hradec Králové, Czechia
KalVista Investigative Site
Pilsen, Czechia
Germany
KalVista Investigative Site
Berlin, Germany
KalVista Investigative Site
Frankfurt, Germany
KalVista Investigative Site
Morfelden-Walldorf, Germany
Hungary
KalVista Investigative Site
Budapest, Hungary
Italy
KalVista Investigative Site
Milano-2, Italy
KalVista Investigative Site
Milano, Italy, 1
KalVista Investigative Site
Padova, Italy
Netherlands
KalVista Investigative Site
Amsterdam, Netherlands
North Macedonia
KalVista Investigative Site
Skopje, North Macedonia
Poland
KalVista Investigative Site
Kraków, Poland
KalVista Investigative Site
Warsaw, Poland
United Kingdom
KalVista Investigative Site
Camberley, United Kingdom
KalVista Investigative Site
Cambridge, United Kingdom
KalVista Investigative Site
London, United Kingdom
KalVista Investigative Site
Newcastle, United Kingdom

Sponsors and Collaborators

KalVista Pharmaceuticals, Ltd.

Investigators

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Study Director:	Study Director	KalVista Pharmaceuticals, Ltd.

More Information

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Responsible Party:	KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:	NCT04208412
Other Study ID Numbers:	KVD900-201
First Posted:	December 23, 2019 Key Record Dates
Last Update Posted:	January 6, 2021
Last Verified:	January 2021

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Angioedema Angioedemas, Hereditary Hereditary Angioedema Types I and II Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases	Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Hereditary Complement Deficiency Diseases Primary Immunodeficiency Diseases Genetic Diseases, Inborn Immunologic Deficiency Syndromes

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