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New hope for kids with rare swelling disorder: sebetralstat shows promise

NCT ID NCT06467084

Symptom relief Sponsor: KalVista Pharmaceuticals, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tested a drug called sebetralstat in 36 children aged 2 to 11 with hereditary angioedema (HAE) types I or II, a condition that causes sudden, painful swelling. The goal was to see if the drug is safe and how well it works to relieve attacks. The trial was open-label, meaning everyone knew they were getting the drug, and it has already been completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sebetralstat (KVD900)
What this could lead to
If it works, this could provide a fast-acting treatment option for children with hereditary angioedema to relieve swelling attacks.
What could go wrong
This was a small, open-label study with no placebo group, so results may be less reliable. Side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

36 people

The number who actually took part.

Started

Aug 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients 2 to 11 years of age. 2. Confirmed diagnosis of HAE Type I or II. 3. For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening. 4. Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary. 5. Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements. 6. Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable). Exclusion Criteria: 1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria. 2. A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator. 3. Patient weighs \<9.5 kg. 4. Use of angiotensin-converting enzyme inhibitors after the Screening Visit. 5. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit. 6. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers. 7. 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. 8. Known hypersensitivity to sebetralstat or to any of the excipients. 9. Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2 hereditary angioedema with C1Inh deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema

Contacts and locations

Locations

  • KalVista Investigative Site

    Birmingham, Alabama, 35209, United States

  • KalVista Investigative Site

    Scottsdale, Arizona, 85251, United States

  • KalVista Investigative Site

    San Diego, California, 92123, United States

  • KalVista Investigative Site

    Santa Monica, California, 90404, United States

  • KalVista Investigative Site

    Evansville, Indiana, 47715, United States

  • KalVista Investigative Site

    Wheaton, Maryland, 20902, United States

  • KalVista Investigative Site

    St Louis, Missouri, 63141, United States

  • KalVista Investigative Site

    Toledo, Ohio, 43560, United States

  • KalVista Investigative Site

    Hershey, Pennsylvania, 17011, United States

  • KalVista Investigative Site

    Dallas, Texas, 75231, United States

  • KalVista Investigative Site

    Edmonton, Alberta, T6G 2B7, Canada

  • KalVista Investigative Site

    Lille, 59000, France

  • KalVista Investigative Site

    Marseille, 13005, France

  • KalVista Investigative Site

    Paris, 75012, France

  • KalVista Investigative Site

    Frankfurt am Main, 60590, Germany

  • KalVista Investigative Site

    Frankfurt am Main, 60596, Germany

  • KalVista Investigative Site

    Haifa, 31048, Israel

  • KalVista Investigative Site

    Petah Tikva, 4920235, Israel

  • KalVista Investigative Site

    Tel Aviv, 6423906, Israel

  • KalVista Investigative Site

    Milan, 20097, Italy

  • KalVista Investigative Site

    Padova, 35128, Italy

  • KalVista Investigative Site

    Rome, 00133, Italy

  • KalVista Investigative Site

    Kawagoe, 350-8550, Japan

  • KalVista Investigative Site

    Tokyo, 113-8431, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.