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A Phase 2, Open-Label, Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Participants From Jasper-Sponsored Chronic Urticaria Trials | Clinical Trials | Clareo Health

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A Phase 2, Open-Label, Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Participants From Jasper-Sponsored Chronic Urticaria Trials

Open-Label Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Chronic Urticaria

NCT06736262•Jasper Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a 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, specifically the BEACON (JSP-CP-011) and SPOTLIGHT (JSP CP-010) trials (referred to as "parent studies") and future CU trials sponsored by Jasper Therapeutics.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provides informed written consent.
•2. Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
•3. Disease specific eligibility:
•1. Participants with CSU have a UAS7 of 16 or greater 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 UAS7 score.
•2. 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.
•4. The laboratory parameters to be within the acceptable range as follows:
•1. Hemoglobin: ≥ 10 g/dL
•2. Platelets: ≥ 100,000/mm3
•3. Neutrophils: ≥ 1,500/mm3
•4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 × the upper limit of normal (ULN)
+5 more criteria

Exclusion Criteria

•1. Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial.
•2. Other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, systemic or cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
•3. Women who are pregnant or nursing or intend to become pregnant during the course of the trial
•4. Any known contraindications or hypersensitivity to any component of briquilimab, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines or leukotrienes. Those who have previously experienced an IP-related anaphylactic event, IP-related SAE, or IP-related AE that led to treatment discontinuation in a prior Jasper-sponsored urticaria clinical trial, which in the opinion of the Investigator or medical monitor, may indicate that continued treatment could present an unreasonable risk to the participant are also excluded.
•5. 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.

Locations (19)

Investigative Site 118

Birmingham, Alabama, United States

Investigative Site 108

Little Rock, Arkansas, United States

Investigative Site 105

San Diego, California, United States

Investigative Site 116

Tampa, Florida, United States

Investigative Site 109

Boise, Idaho, United States

Investigative Site 124

Normal, Illinois, United States

Investigative Site 110

Indianapolis, Indiana, United States

Investigative Site 123

Lafayette, Louisiana, United States

Investigative Site 101

Baltimore, Maryland, United States

Investigative Site 121

White Marsh, Maryland, United States

Key Dates

Start Date

November 26, 2024

Primary Completion Date

August 13, 2026

Completion Date

September 30, 2026

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

Urticaria Chronic

Interventions

Briquilimab

DRUG