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 |
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Recruitment Status :
Completed
First Posted : December 23, 2019
Last Update Posted : January 6, 2021
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Sponsor:
KalVista Pharmaceuticals, Ltd.
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.
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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 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
| Arm | Intervention/treatment |
|---|---|
| Experimental: KVD900 |
Drug: KVD900
KVD900 tablet |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo to KVD900 Tablet |
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 ]
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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
Information from the National Library of Medicine
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
| 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
| Study Director: | Study Director | KalVista Pharmaceuticals, Ltd. |
| 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 |
| 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 |