Hereditary AngioedemaPhase 3NCT05505916
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
A Phase 3 study testing KVD900 600 mg and KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 71 sites in 23 countries.
Trial summary
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD900 600 mg and KVD900 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 71 sitesin 23 countries
- Study dates
- 24 Oct 2022to 27 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of HAE type I or II at any time in the medical history
- Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit).
- Male or female patients 12 years of age and older.
- Patients must meet the contraception requirements.
- Patients must be able to swallow trial tablets whole.
Show all 9Show fewer
- Patients, as 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 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.
Who cannot join
- Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
- Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
- 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 attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit.
- Use of Angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Enrollment Visit.
Show all 19Show fewer
- Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Enrollment Visit.
- Inadequate organ function, including but not limited to:
- Alanine aminotransferase (ALT) >2x Upper Limit 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 to any of the excipients.
- 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 the Enrollment Visit.
- Any pregnant or breastfeeding patient.
Trial locations and contacts
71 sites in 23 countries.
71 sites in 23 countries
United States20 sites
KalVista Investigative Site
Centennial, Colorado, 80112
KalVista Investigative Site
Charlotte, North Carolina, 28277
KalVista Investigative Site
Chevy Chase, Maryland, 20815
KalVista Investigative Site
Cincinnati, Ohio, 45236
KalVista Investigative Site
Colorado Springs, Colorado, 80907
KalVista Investigative Site
Dallas, Texas, 75231
KalVista Investigative Site
Evansville, Indiana, 47715
KalVista Investigative Site
Hershey, Pennsylvania, 17033
KalVista Investgative Site
Layton, Utah, 84041
KalVista Investigative Site
Little Rock, Arkansas, 72205
KalVista Investigative Site
Louisville, Kentucky, 40215
KalVista Investigative Site
Overland Park, Kansas, 66211
KalVista Investigative Site
Plymouth, Minnesota, 55446
KalVista Investigative Site
San Diego, California, 92122
KalVista Investigative Site
San Diego, California, 92123
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, 63141
KalVista Investigative Site
Toledo, Ohio, 43617
Japan9 sites
KalVista Investigative Site
Chiba, 260-8677
KalVista Investigative Site
Hiroshima, 730-8518
KalVista Investigative Site
Kawagoe-shi, 350-8550
KalVista Investigative Site
Maebashi, 371-8511
KalVista Investigative Site
Sapporo, Hokkaido, 002-8072
KalVista Investigative Site
Soka-shi, 340-0041
KalVista Investigative Site
Takatsuki-shi, 569-8686
KalVista Investgative Site
Tokyo, 142-8666
KalVista Investigative Site
Yokohama, 236-0004
United Kingdom7 sites
KalVista Investigative Site
Birmingham, B9 5SS
KalVista Investigative Site
Cambridge, CB2 0QQ
KalVista Investigative Site
Cardiff, CF14 4XW
KalVista Investigative Site
Frimley, GU16 7UJ
KalVista Investigative Site
Leeds, LS9 7TF
KalVista Investigative Site
London, E1 2ES
KalVista Investigative Site
London, NW3 2QG
Germany4 sites
KalVista Investigative Site
Berlin, 12203
KalVista Investigative Site
Frankfurt, 60590
KalVista Investigative Site
Mainz, 55131
KalVista Investigative Site
Mörfelden-Walldorf, 64546
Israel4 sites
KalVista Investigative Site
Haifa, 31048
KalVista Investigative Site
Petach Tikvah, 4920235
KalVista Investigative Site
Ramat Gan, 52621
KalVista Investigative Site
Tel Aviv, 64239
Italy4 sites
KalVista Investigative Site
Padova, 35128
KalVista Investigative Site
Palermo, 90146
KalVista Investigative Site
Roma, 00133
KalVista Investigative Site
San Donato Milanese, 20097
France3 sites
KalVista Investigative Site
Grenoble, 38043
KalVista Investigative Site
Lille, 59037
KalVista Investigative Site
Paris, 75012
Spain3 sites
KalVista Investigative Site
Barcelona, 08035
KalVista Investigative Site
Barcelona, 08907
KalVista Investigative Site
Madrid, 28046
Greece2 sites
KalVista Investigative Site
Athens, 11521
KalVista Investigative Site
Athens, 11527
Poland2 sites
KalVista Investigative Site
Krakow, 31-503
KalVista Investigative Site
Lodz, 92-213
About this study
Official title: An Open-label Extension Trial to Evaluate the Long-term Safety 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
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD900 600 mg, KVD900 300 mg
- Keywords
- KONFIDENT-S, Sebetralstat
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD900 600 mgDrug
KVD900 Tablet 600 mg (2 x 300 mg)
KVD900 300 mgDrug
KVD900 Tablet 300 mg
| Study group | Role | What they receive |
|---|---|---|
| KVD900 600 mg | Experimental | Not described Receives: Drug: KVD900 600 mg |
| KVD900 300 mg | Experimental | Not described Receives: Drug: KVD900 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Measured: AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient.
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Measured: Throughout the duration of the trial.
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Measured: Throughout the duration of the trial.
Secondary outcomes (3)
Patient Global Impression of Change (PGI-C).
time to beginning of symptom relief defined as at least '' a little better'' (2 time points in a row)
Measured: within 12 hours of initial dose of IMP administration.
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
Measured: within 12 hours of initial dose of IMP administration.
PGI-S: time to HAE attack resolution
PGI-S: time to HAE attack resolution, defines as ''none''
Measured: within 24 hours of initial dose of IMP administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start24 Oct 2022
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 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, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505916
- Sponsor's protocol ID
- KVD900-302
- Status last verified
- May 2026
- First submitted
- 11 Aug 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared until all global regulatory filings are complete.
Publications
Kinaciyan T, Aygoren-Pursun E, Martinez-Saguer I, Soteres DF, Honda D, Manning ME, Wedner HJ, Fukunaga A, Kanarek HJ, Ohmura K, Melamed I, El-Shanawany T, Bouillet L, Lumry WR, Riedl MA, Koleilat M, Geng B, Ohsawa I, Bara N, Rehman S, Bernstein JA, Busse PJ, Cancian M, Cohn DM, Craig TJ, Farkas H, Kiani-Alikhan S, Li HH, Raasch JP, Tachdjian R, Audhya PK, Bajcic P, Chuang YH, Iverson M, Smith MD, Yea CM, Zanichelli A. Sebetralstat for breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis in KONFIDENT-S. J Allergy Clin Immunol Glob. 2026 Jun 12;5(5):100750. doi: 10.1016/j.jacig.2026.100750. eCollection 2026 Sep.
PubMed 42436759Bernstein JA, Aygoren-Pursun E, Cancian M, Cohn DM, Craig T, Grivcheva-Panovska V, Jordan A, Lumry WR, Martinez-Saguer I, Melamed I, Ohmura K, Peter J, Riedl MA, Soteres DF, Staubach P, Stobiecki M, Chuang YH, Smith MD, Yea CM, Audhya PK, Zanichelli A, Farkas H. Sebetralstat for On-Demand Treatment of Mucosal Hereditary Angioedema Attacks in KONFIDENT-S. Clin Transl Allergy. 2025 Nov;15(11):e70118. doi: 10.1002/clt2.70118.
PubMed 41252457Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29.
PubMed 40886933
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Trial to Evaluate the Long-term Safety 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
- ClinicalTrials.gov ID
- NCT05505916
- Acronym / sponsor ID
- KVD900-302
- Conditions
- Hereditary Angioedema
- Keywords
- KONFIDENT-S, Sebetralstat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KVD900 600 mg | Experimental | Drug: KVD900 600 mg |
| KVD900 300 mg | Experimental | Drug: KVD900 300 mg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of HAE type I or II at any time in the medical history
- Patient has had at least 2 documented HAE attacks within 3 months prior to the Enrollment Visit.
- If a patient is receiving long-term prophylactic treatment with one of the protocol-allowed therapies, they must have been on a stable dose and regimen for at least 3 months prior to the Enrollment Visit (except for danazol, which requires a stable dose and regimen for at least 6 months prior to the Enrollment Visit).
- Male or female patients 12 years of age and older.
- Patients must meet the contraception requirements.
Key exclusion criteria (19 listed)
- Discontinued from the KVD900-301 trial for reasons of noncompliance, withdrawal of consent, or safety.
- Presence of any safety concerns that would preclude participation in the open-label trial as determined by the investigator.
- 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 attenuated androgens other than danazol (e.g., stanozolol, oxandrolone, methyltestosterone, testosterone), or anti-fibrinolytics (e.g., tranexamicacid) within 28 days prior to the Enrollment Visit.
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 |
|---|---|---|
| KVD900 600 mgKVD900 Tablet 600 mg (2 x 300 mg) | Drug | KVD900 600 mg |
| KVD900 300 mgKVD900 Tablet 300 mg | Drug | KVD900 300 mg |
Primary outcome
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation.
Time frame: AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient.
Number and percentage of patients with normal or abnormal laboratory results at each scheduled visit.
Time frame: Throughout the duration of the trial.
Number and percentage of patients with normal or abnormal vital sign results at each scheduled visit
Time frame: Throughout the duration of the trial.
3 secondary outcomes
Patient Global Impression of Change (PGI-C).
Time frame: within 12 hours of initial dose of IMP administration.
Patient Global Impression of Severity (PGI-S): time to first incidence of 2 time points in a row decrease from baseline
Time frame: within 12 hours of initial dose of IMP administration.
PGI-S: time to HAE attack resolution
Time frame: within 24 hours of initial dose of IMP administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42436759Kinaciyan T, Aygoren-Pursun E, Martinez-Saguer I, Soteres DF, Honda D, Manning ME, Wedner HJ, Fukunaga A, Kanarek HJ, Ohmura K, Melamed I, El-Shanawany T, Bouillet L, Lumry WR, Riedl MA, Koleilat M, Geng B, Ohsawa I, Bara N, Rehman S, Bernstein JA, Busse PJ, Cancian M, Cohn DM, Craig TJ, Farkas H, Kiani-Alikhan S, Li HH, Raasch JP, Tachdjian R, Audhya PK, Bajcic P, Chuang YH, Iverson M, Smith MD, Yea CM, Zanichelli A. Sebetralstat for breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis in KONFIDENT-S. J Allergy Clin Immunol Glob. 2026 Jun 12;5(5):100750. doi: 10.1016/j.jacig.2026.100750. eCollection 2026 Sep.
- Derived from this study: PubMed 41252457Bernstein JA, Aygoren-Pursun E, Cancian M, Cohn DM, Craig T, Grivcheva-Panovska V, Jordan A, Lumry WR, Martinez-Saguer I, Melamed I, Ohmura K, Peter J, Riedl MA, Soteres DF, Staubach P, Stobiecki M, Chuang YH, Smith MD, Yea CM, Audhya PK, Zanichelli A, Farkas H. Sebetralstat for On-Demand Treatment of Mucosal Hereditary Angioedema Attacks in KONFIDENT-S. Clin Transl Allergy. 2025 Nov;15(11):e70118. doi: 10.1002/clt2.70118.
- Derived from this study: PubMed 40886933Farkas H, Anderson J, Bouillet L, Caballero T, Cancian M, Craig T, Fukunaga A, Grivcheva-Panovska V, Guilarte M, Honda D, Kanarek H, Kiani-Alikhan S, Kinaciyan T, Leguevaques D, Longhurst HJ, Magerl M, Manning ME, Martinez-Saguer I, Melamed I, O'Connor ME, Peter J, Savic S, Soteres DF, Staevska M, Staubach P, Stobiecki M, Tachdjian R, Valerieva A, Yong PFK, Hao J, Iverson M, Smith MD, Yea CM, Audhya PK, Aygoren-Pursun E, Bernstein JA, Cohn DM, Lumry WR, Riedl MA, Zanichelli A, Maurer M. Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3094-3103.e5. doi: 10.1016/j.jaip.2025.08.020. Epub 2025 Aug 29.
- Individual participant dataSharing planned: No. Data will not be shared until all global regulatory filings are complete.
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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, Ltd.
71 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KVD900 600 mg and KVD900 300 mg in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 71 sites in 23 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Japan, United Kingdom, Germany, Israel and 18 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequencies and percentages of patients with AEs, AEs within 2 days of IMP administration, serious AE's and AEs causing premature discontinuation. (time frame: AEs will be recorded from the first dose of IMP in the KVD900-302 trial up to and including the end of study (EOS) visit, a maximum of 2 years for each patient.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505916, which also lists 3 linked publications.
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 5 Jun 2026.