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Monoclonal Antibodies

Briquilimab for Chronic Hives (BEACON Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Jasper Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite treatment with omalizumab or intolerance to omalizumab

Presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines

Must not have

Women who are pregnant or nursing or intend to become pregnant during the course of the trial

Dominant comorbid chronic urticaria with a clearly defined predominant or sole trigger (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 12 and all assessment time points through week 48

Summary

This trial will check the safety and effectiveness of a new drug for treating chronic hives in adults. It will also look at its pharmacological properties.

Who is the study for?

Adults over 18 with chronic spontaneous urticaria (CSU) who still have symptoms despite taking H1 antihistamines and omalizumab can join. They must not be pregnant, nursing, or planning pregnancy; should not have other active diseases mimicking CSU; no recent use of certain medications like JAK inhibitors; and willing to use contraception if applicable.

What is being tested?

The trial is testing Briquilimab's safety, how the body processes it, and its initial effectiveness in treating CSU compared to a placebo. It starts with an open-label phase where everyone gets Briquilimab, followed by a randomized double-blind phase where participants get either Briquilimab or a placebo without knowing which one.

What are the potential side effects?

Possible side effects of Briquilimab are not detailed here but may include reactions similar to other monoclonal antibodies such as infusion-related reactions, fatigue, headaches, potential allergic responses or impacts on immune function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had itch and hives for 8 weeks or more, even with omalizumab treatment or cannot tolerate it.

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I have had itch and hives for 8 weeks or more, even while taking antihistamines.

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I have had symptoms of chronic hives for 6 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have chronic hives triggered by specific conditions like temperature or pressure.

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I haven't taken any immunosuppressive drugs in the last 4 weeks or more.

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My kidney function, measured by creatinine clearance, is below 60 mL/min.

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I have HIV, hepatitis B or C, or am experiencing long-term effects of COVID.

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I haven't had major surgery in the last 8 weeks and don't plan any during the trial.

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I am not willing to use effective birth control during and for 150 days after the trial.

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I don't have any health or mental conditions that could affect the trial.

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I agree not to donate blood while participating in the trial.

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I am not allergic to the study drug or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 12 and all assessment time points through week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 12 and all assessment time points through week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 12 and all assessment time points through week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the safety and tolerability of briquilimab

Secondary study objectives

Area under the time-concentration curve from time zero to the last quantifiable concentration (AUClast)

Evaluate the preliminary efficacy of briquilimab - Urticaria Control Test (UCT)

Evaluate the preliminary efficacy of briquilimab-- UAS7 Score

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BriquilimabExperimental Treatment1 Intervention

This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.

Group II: PlaceboPlacebo Group1 Intervention

Placebo Comparator

0 / 13Eligibility criteria met