A Phase 2 interventional study of KVD900 and Placebo in Hereditary Angioedema, sponsored by KalVista Pharmaceuticals, Ltd.. Completed at 25 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by KalVista Pharmaceuticals, Ltd. (part of Chiesi Farmaceutici S.p.A.) · Phase 2, Interventional, and Treatment
Among 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. — 1 open to participants now, 1 under way, none of them phase 3. Angioedemas, Hereditary · KalVista Pharmaceuticals, Ltd..
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., this one is one of 2 that started in 2019, is the only one in phase 2, and was the 1st registered.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
Browse Angioedemas, Hereditary studies →1 of the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. is open now, in 1 country. Recruiting first, the newest first:
KalVista Pharmaceuticals, Ltd. · Sites in United States
By country, each count listing its studies:
Of the 13 Angioedemas, Hereditary studies recruiting now, 9 (69%) set no upper age limit and 4 (31%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2019.
This study's enrollment of 84 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Median enrollment 84 across the 9 interventional studies, 88 across the 1 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
KalVista Pharmaceuticals, Ltd. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
1 of the studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07654829KalVista Pharmaceuticals, Ltd.Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) | 2027-11-29 |
Among the 12 studies in Angioedemas, Hereditary by KalVista Pharmaceuticals, Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received a single dose of 600 mg KVD900.
Drug: KVD900
Subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack.
Drug: KVD900 · Other: Placebo
Subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.
Drug: KVD900 · Other: Placebo
KVD900 tablet 600 mg
KVD900-matched Placebo Tablet
Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set)
The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Proportion of HAE Attacks That Worsen in Severity by One Level or More on the PGI-S or Require Conventional Attack Treatment Within 12 Hours of Study Drug (Full Analysis Set)
The proportion of participant's HAE attacks to either worsen in attack severity on the PGI-S by one level or more or conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) use are listed with censored observations flagged. Frequencies (n, %) of subjects experiencing a worsening on the PGI-S by one level or more or using conventional attack treatment and the number censored are presented. "Y" Row indicates "participants who experienced a worsening in severity, and the "N" Row indicates participants who did not.
Time frame: 12 hours
Time to Either Worsening in HAE Attack Severity by One Level or More on the PGI-S or to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set)
HAE attack severity assessed using the Patient Global Impression of Severity scale (PGI-S). Censoring occurs where a subject did not worsen in severity or use conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Time to Symptom Relief Defined as HAE Attack Rated as "A Little Better" or Higher on the PGI-C for Two Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set)
Change in HAE attack severity assessed using the Patient Global Impression of Change 7-point transition question (PGI-C). Censoring occurs where an attack rating of "a little better" or higher for two consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
Time to Symptom Relief Defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set)
The HAE attack symptoms were assessed on a 100 mm visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe). The Composite VAS score is defined as the mean score across all symptoms. Censoring occurs where a ≥50% reduction in Composite VAS Score for three consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur the event must have occurred \>12 hours following study drug.
Time frame: 12 hours
A total of 84 subjects were enrolled, of which 16 were screen failures. The majority of screen failures were due to inclusion criterion not met.
| Milestone | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 |
|---|---|---|
| Started | 34 | 34 |
| Completed | 25 | 28 |
| Not completed | 9 | 6 |
| Withdrew: Early discontinuation per protocol; sufficient number of subjects completed the study | 8 | 5 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
| Time (h) | 600 mg KVD900 | Placebo |
|---|---|---|
| Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | NA (NA to NA) | NA (NA to NA) |
The proportion of participant's HAE attacks to either worsen in attack severity on the PGI-S by one level or more or conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) use are listed with censored observations flagged. Frequencies (n, %) of subjects experiencing a worsening on the PGI-S by one level or more or using conventional attack treatment and the number censored are presented. "Y" Row indicates "participants who experienced a worsening in severity, and the "N" Row indicates participants who did not.
| Participants | 600 mg KVD900 | Placebo |
|---|---|---|
| Y | 11 | 24 |
| N | 42 | 29 |
HAE attack severity assessed using the Patient Global Impression of Severity scale (PGI-S). Censoring occurs where a subject did not worsen in severity or use conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
| Time (h) | 600 mg KVD900 | Placebo |
|---|---|---|
| Time to Either Worsening in HAE Attack Severity by One Level or More on the PGI-S or to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | NA (NA to NA) | NA (6.0 to NA) |
Change in HAE attack severity assessed using the Patient Global Impression of Change 7-point transition question (PGI-C). Censoring occurs where an attack rating of "a little better" or higher for two consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
| Time (h) | 600 mg KVD90 | Placebo |
|---|---|---|
| Time to Symptom Relief Defined as HAE Attack Rated as "A Little Better" or Higher on the PGI-C for Two Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | 1.6 (1.5 to 3.0) | 9.0 (4.0 to NA) |
The HAE attack symptoms were assessed on a 100 mm visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe). The Composite VAS score is defined as the mean score across all symptoms. Censoring occurs where a ≥50% reduction in Composite VAS Score for three consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur the event must have occurred \>12 hours following study drug.
| Time (h) | 600 mg KVD900 | Placebo |
|---|---|---|
| Time to Symptom Relief Defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | 6.0 (3.0 to 9.0) | NA (NA to NA) |
Collected over Adverse events were collected over the maximum duration of randomized subject participation from screening until final visit (up to 19 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: 600 mg KVD900 | 0/68 (0%) | 0/68 (0%) | 7/68 (10.3%) |
| Part 2: 600 mg KVD900 | 0/58 (0%) | 0/58 (0%) | 8/58 (13.8%) |
| Part 2: Placebo | 0/55 (0%) | 0/55 (0%) | 5/55 (9.1%) |
| Event | Part 1: 600 mg KVD900 | Part 2: 600 mg KVD900 | Part 2: Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 2/68 | 3/58 | 1/55 |
| NasopharyngitisInfections and infestations | 1/68 | 0/58 | 2/55 |
| NauseaGastrointestinal disorders | 1/68 | 2/58 | 0/55 |
| FlushingVascular disorders | 2/68 | 0/58 | 0/55 |
| Abdominal pain upperGastrointestinal disorders | 0/68 | 1/58 | 1/55 |
| Anal incontinenceGastrointestinal disorders | 0/68 | 0/58 | 1/55 |
| VomitingGastrointestinal disorders | 0/68 | 1/58 | 1/55 |
| VertigoEar and labyrinth disorders | 0/68 | 1/58 | 0/55 |
| Dry mouthGastrointestinal disorders | 0/68 | 1/58 | 0/55 |
| CystitisInfections and infestations | 0/68 | 1/58 | 0/55 |
| Age, Continuous(years) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Mean | 41.0 ± 12.97 | 35.5 ± 13.12 | 38.3 ± 13.23 |
| Sex: Female, Male(Participants) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Female | 22 | 15 | 37 |
| Male | 12 | 19 | 31 |
| Ethnicity (NIH/OMB)(Participants) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 33 | 33 | 66 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 34 | 34 | 68 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Height(meters) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Mean | 1.711 ± 0.0837 | 1.730 ± 0.1039 | 1.720 ± 0.0941 |
| Weight(kg) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Mean | 79.89 ± 18.335 | 82.04 ± 18.865 | 80.97 ± 18.495 |
| BMI(kg/m^2) | 600 mg KVD900, Then Placebo | Placebo, Then 600 mg KVD900 | Total |
|---|---|---|---|
| Mean | 27.242 ± 5.7344 | 27.336 ± 5.2691 | 27.289 ± 5.4656 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2019 to primary completion in Dec 2020, 17 months.
Results were first posted in Feb 2023, 2 years 2 months after primary completion.
Of 17 phase 2 interventional studies under Angioedemas, Hereditary, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sebetralstat
KalVista Pharmaceuticals, Ltd. →