Briquilimab for Hives

Recruiting at 17 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

90 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.

Research Team

Medical Director

Principal Investigator

Jasper Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+