Angioedema, Hereditary, Types I and IIPhase 2KVD824-201NCT05055258
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
A Phase 2 study testing KVD824 in people with Angioedema, Hereditary, Types I and II, run by KalVista Pharmaceuticals, Ltd. at 33 sites in 13 countries.
Trial summary
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioedema, Hereditary, Types I and II
- What is being tested?
- KVD824
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 33 sitesin 13 countries
- Study dates
- 18 Nov 2021to 27 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age and older.
- Confirmed diagnosis of HAE type I or II at any time in the medical history:
- Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria) AND EITHER
- Diagnostic testing results obtained prior to randomization that confirm HAE Type I or II: C1-INH functional level <40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range. Testing may be obtained from central or local laboratories or obtained from documented historical testing results. Subjects may be restested at anytime prior to randomization if results are incongruent with clinical history or believed by the Investigator to be confounded by recent prophylactic or therapeutic C1 INH use, OR
- Documented genetic results that confirm known mutations for HAE Type I or II.
- Subject has access to and ability to use conventional treatment for HAE attacks.
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- Subject is willing to cease any current medications being taken for HAE prophylaxis and Investigator determines that doing so would not place the subject at any undue safety risk.
- Subject's last dose of attenuated androgens was at least 28 days prior to first dose of IMP.
- During the Run-in Period subject meets one of the following criteria:
- Two Investigator-confirmed attacks in the first 4-week period.
- Three Investigator-confirmed attacks in ≤8 weeks.
- Subjects who are fertile and heterosexually active must adhere to contraception requirements throughout the trial as follows:
- Female subjects must agree to use at least one highly effective contraception method from the Screening Visit until the end of the trial. Highly effective methods of contraception include: i) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral/injectable/implantable (hormonal contraception that contains estrogen including ethinylestradiol is excluded per Exclusion 4).
- Intrauterine device (IUD). iii) Intrauterine hormone-releasing system (IUS). iv) Bilateral tubal occlusion. v) Vasectomized partner (provided that the partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of surgical success).
- Male subjects with a female partner of childbearing potential must agree to use condoms for the entire Treatment Period AND for 90 days following the final dose of investigational medicinal product (IMP). Female partners are encouraged to use contraception as outlined in Inclusion 7a) from the Screening Visit until the end of the trial. Hormonal contraception that contains estrogen including ethinylestradiol is acceptable for the female partner.
- Subjects who are not fertile or not sexually active, as defined below, do not require contraception.
- Subjects who refrain from heterosexual intercourse during the trial if the reliability of the heterosexual abstinence has been evaluated in relation to the duration of the clinical trial and is the preferred and usual lifestyle of the subject.
- Male subjects who are surgically sterile (e.g. vasectomized with medical assessment of surgical success).
- Female subjects who are surgically sterile (e.g. status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post menopausal for at least 12 months.
- Subjects must be able to swallow trial tablets whole.
- Subjects assessed by the Investigator must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary.
- Investigator believes that the subject is willing and able to adhere to all protocol requirements.
- Subject provides signed informed consent and is willing and capable of complying with trial requirements and procedures.
Who cannot join
- 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 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) after the Screening Visit or within 7 days prior to randomization.
- Use of narrow therapeutic index drugs metabolized by CYP3A4 or CYP2C9 or transported by OAT1, OCT2, and OATP1B1, starting at screening, as determined by the Investigator.
- Use of strong CYP3A4 inhibitors and inducers during participation in the trial, starting at the Screening Visit.
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- Note: These medications include but are not limited to the following:
- Inhibitors: boceprevir, clarithromycin, cobicistat, dasabuvir, denoprevir, elvitegravir, idelalisib, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, and voriconazole.
- Inducers: apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort.
- 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.
- Estimated glomerular filtration rate (eGFR) <60 mL/min.
- Any clinically significant comorbidity or systemic dysfunction that in the opinion of the Investigator would jeopardize the safety of the subject 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 KVD824 or placebo or to any of the excipients.
- Any prior use of any gene therapy treatment 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 subject.
Trial locations and contacts
33 sites in 13 countries.
33 sites in 13 countries
United States13 sites
KalVista Investigative Site
Birmingham, Alabama, 35294
KalVista Investigative Site
Boston, Massachusetts, 02114
KalVista Investigative Site
Centennial, Colorado, 80112
KalVista Investigative Site
Chevy Chase, Maryland, 20815
KalVista Investigative Site
Cincinnati, Ohio, 45231
KalVista Investigative Site
Dallas, Texas, 75390
KalVista Investigative Site
Hershey, Pennsylvania, 17033
KalVista Investigative Site
La Jolla, California, 92093
KalVista Investigative Site
Santa Monica, California, 90404
KalVista Investigative Site
Scottsdale, Arizona, 85251
KalVista Investigative Site
Spokane, Washington, 99204
KalVista Investigative Site
St Louis, Missouri, 63110
KalVista Investigative Site
Tampa, Florida, 33620
United Kingdom4 sites
KalVista Investigative Site
Birmingham
KalVista Investigative Site
Leeds
KalVista Investigative Site
London
KalVista Investigative Site
Newcastle upon Tyne
Germany3 sites
KalVista Investigative Site
Berlin
KalVista Investigative Site
Frankfurt am Main
KalVista Investigative Site
Mainz, Rhineland-Palatinate
Czechia2 sites
KalVista Investigative Site
Brno
KalVista Investigative Site
Prague
France2 sites
KalVista Investigative Site
Grenoble
KalVista Investigative Site
Paris
Italy2 sites
KalVista Investigative Site
Milan
KalVista Investigative Site
Padova
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
- Conditions
- Angioedema, Hereditary, Types I and II
- Being tested
- KVD824, Placebo to KVD824
- Keywords
- KVD824, KOMPLETE
- Medical subject headings
- Hereditary Angioedema Types I and II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD824Drug
KVD824 300 mg Modified-Release Tablets
Placebo to KVD824Drug
Placebo to KVD824 300 mg Modified-Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| 300 mg KVD824 | Experimental | 300 mg KVD824 twice a day for 12 weeks Receives: Drug: KVD824 |
| 600 mg KVD824 | Experimental | Two 300 mg KVD824 tablets twice a day for 12 weeks Receives: Drug: KVD824 |
| 900 mg KVD824 | Experimental | Three 300 mg KVD824 tablets twice a day for 12 weeks Receives: Drug: KVD824 |
| Placebo to KVD824 | Placebo comparator | One, two or three placebo tablets to be taken twice a day for 12 weeks Receives: Drug: Placebo to KVD824 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period
To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo.
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Secondary outcomes (5)
Proportion of Subjects Without Investigator-confirmed HAE Attacks During the Treatment Period.
Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS).
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Rate of Investigator-confirmed HAE Attacks That Require Conventional Treatment During the Treatment Period.
A summary of negative binomial regression on investigator-confirmed HAE attacks with conventional treatment is presented for the FAS.
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Angioedema Quality of Life Questionnaire (AE-QoL) Total Score During the Treatment Period (Change From Baseline)
AE-QoL is a quality of life questionnaire with a range of 0 (minimum) to 100 (maximum). A total score of 100 indicates worst possible impairment.
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Angioedema Control Test (AECT) Score During the Treatment Period (Change From Baseline).
AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.
AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.
Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start18 Nov 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Why it stopped: Terminated by Sponsor due to adverse events reported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Angioedema, Hereditary, Types I and IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, KalVista Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055258
- Sponsor's protocol ID
- KVD824-201
- Acronym
- KVD824-201
- Status last verified
- May 2026
- First submitted
- 14 Sep 2021
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
- ClinicalTrials.gov ID
- NCT05055258
- Acronym / sponsor ID
- KVD824-201 / KVD824-201
- Conditions
- Angioedema, Hereditary, Types I and II
- Keywords
- KVD824, KOMPLETE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by Sponsor due to adverse events reported
- Enrolment
- 33 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 300 mg KVD824 | Experimental | Drug: KVD824300 mg KVD824 twice a day for 12 weeks |
| 600 mg KVD824 | Experimental | Drug: KVD824Two 300 mg KVD824 tablets twice a day for 12 weeks |
| 900 mg KVD824 | Experimental | Drug: KVD824Three 300 mg KVD824 tablets twice a day for 12 weeks |
| Placebo to KVD824 | Placebo comparator | Drug: Placebo to KVD824One, two or three placebo tablets to be taken twice a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female subjects 18 years of age and older.
- Confirmed diagnosis of HAE type I or II at any time in the medical history:
- Subject has access to and ability to use conventional treatment for HAE attacks.
- Subject is willing to cease any current medications being taken for HAE prophylaxis and Investigator determines that doing so would not place the subject at any undue safety risk.
- Subject's last dose of attenuated androgens was at least 28 days prior to first dose of IMP.
Key exclusion criteria (22 listed)
- 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 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) after the Screening Visit or within 7 days prior to randomization.
- Use of narrow therapeutic index drugs metabolized by CYP3A4 or CYP2C9 or transported by OAT1, OCT2, and OATP1B1, starting at screening, as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KVD824KVD824 300 mg Modified-Release Tablets | Drug | 300 mg KVD824, 600 mg KVD824, 900 mg KVD824 |
| Placebo to KVD824Placebo to KVD824 300 mg Modified-Release Tablets | Drug | Placebo to KVD824 |
Primary outcome
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period
Time frame: 12 weeks
To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.
5 secondary outcomes
Proportion of Subjects Without Investigator-confirmed HAE Attacks During the Treatment Period.
Time frame: 12 weeks
Rate of Investigator-confirmed HAE Attacks That Require Conventional Treatment During the Treatment Period.
Time frame: 12 weeks
Angioedema Quality of Life Questionnaire (AE-QoL) Total Score During the Treatment Period (Change From Baseline)
Time frame: 12 weeks
Angioedema Control Test (AECT) Score During the Treatment Period (Change From Baseline).
Time frame: 12 weeks
Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Angioedema, Hereditary, Types I and II
Enrolling by invitationPhase 2/3
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema, Hereditary Angioedema Type I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
KalVista Pharmaceuticals
33 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KVD824 in people with Angioedema, Hereditary, Types I and II, run by KalVista Pharmaceuticals, Ltd. at 33 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, United Kingdom, Germany, Czechia, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.