Briquilimab for Hives

Enrolling by invitation at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jasper Therapeutics, Inc.

Must not be taking: Antihistamines, Leukotrienes

Disqualifiers: Pregnancy, Urticarial vasculitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of briquilimab (also known as JSP191 or AMG-191) for individuals with persistent hives. It specifically targets those who previously tried briquilimab in a study without severe allergic reactions. The trial seeks participants who recently completed a Jasper-sponsored study on hives and continue to experience significant symptoms, such as frequent hives or skin reactions to cold. Participants must agree to refrain from donating blood during the trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that briquilimab is likely to be safe for humans?

Previous studies have shown that briquilimab is well tolerated. Researchers reported no serious side effects, and even minor side effects were rare. Research indicates that patients experienced either no side effects or only mild ones. This suggests briquilimab could be a safe option for treating hives. Ongoing studies will continue to assess its long-term safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for hives, which often includes antihistamines and corticosteroids to manage symptoms, Briquilimab offers a fresh approach by using a new mechanism of action. Briquilimab is administered via a subcutaneous injection and works by targeting specific pathways involved in the allergic response, potentially providing more direct and effective control of hives. Researchers are excited about Briquilimab because it might offer a faster and more sustained relief compared to traditional treatments, improving the quality of life for patients with chronic hives.

What evidence suggests that briquilimab might be an effective treatment for hives?

Research has shown that briquilimab, which participants in this trial will receive, may effectively treat hives. In one study, 14 out of 15 people saw improvement, and in a group taking a 120mg dose, 10 out of 12 experienced complete relief. Another study found that with a 180mg dose, all 12 participants achieved strong symptom control. Additionally, single doses of 240mg and 360mg resulted in 89% of participants experiencing complete relief. These findings suggest briquilimab could help manage hives. ^{2 3 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Jasper Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals who have previously participated in Jasper-sponsored Chronic Urticaria (CU) trials. It's designed to assess the long-term safety and effectiveness of a medication called Briquilimab for those with chronic hives or urticaria.

Inclusion Criteria

Provides informed written consent

Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event

Participants with CIndU (cold contact urticaria [ColdU] or symptomatic dermographism) have a UCT of 12 or less following the completion of at least 8 weeks of safety follow up in the parent study OR anyone who completed their parent study regardless of UCT score

Exclusion Criteria

Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial

Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or briquilimab administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the participant inappropriate for entry into the trial

I am not pregnant, nursing, or planning to become pregnant during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive briquilimab via SQ injection to evaluate long-term safety and clinical activity

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Briquilimab

Trial Overview

The study is testing Briquilimab, an investigational drug, to see how safe it is over a longer period and how well it works in managing symptoms of chronic urticaria when used continuously.

How Is the Trial Designed?

Group I: Briquilimab Experimental Treatment 1 Intervention

Briquilimab via SQ injection

Briquilimab is already approved in European Union for the following indications:

Approved in European Union as Briquilimab for:

• Orphan designation for conditioning treatment prior to hematopoietic stem cell transplant in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD)

Who Is Running the Clinical Trial?

Jasper Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

310+

Citations

1.

ir.jaspertherapeutics.com

ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-reports-positive-data-spotlight-study

News Release Details

14 of 15 participants enrolled achieved a clinical response. 10 of 12 participants in the 120mg cohort achieved a complete response.

2.

ir.jaspertx.com

ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-reports-positive-data-180mg-cohort-spotlight

Jasper Therapeutics Reports Positive Data from 180mg ...

Briquilimab (subcutaneous) administration resulted in deep disease control at 180mg, with 12 of 12 participants (100%) enrolled in the cohort achieving a ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06162728

Study Details | NCT06162728 | Dose Escalation Trial of ...

The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous ...

4.

jacionline.org

jacionline.org/article/S0091-6749(24)02285-1/fulltext

Initial results from BEACON, a phase 1b/2a dose ...

This is an ongoing 3-part study designed to assess the safety, tolerability and preliminary efficacy of subcutaneously administered briquilimab.

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/briquilimab-shows-promising-results-in-chronic-urticaria-studies/

Briquilimab Shows Promising Results in Chronic Urticaria ...

Single doses of 240mg and 360mg of briquilimab showed high efficacy, with 89% of participants achieving a complete response. However, results ...

6.

ir.jaspertx.com

ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-reports-clinical-data-update-briquilimab

Jasper Therapeutics Reports Clinical Data Update from ...

The primary endpoints are safety and tolerability of briquilimab and secondary endpoints are focused on clinical activity and PK/PD, including ...

7.

healio.com

healio.com/news/allergy-asthma/20241213/patients-with-chronic-inducible-urticaria-see-complete-response-to-briquilimab-at-6-weeks

Patients with chronic inducible urticaria see complete ...

Patients with chronic inducible urticaria experienced partial or complete response to briquilimab in 6 weeks with a favorable safety and tolerability profile.