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Monoclonal Antibodies

Briquilimab for Chronic Urticaria (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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

BEACON Trial 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.Check my eligibility

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.See study design

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.

BEACON Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

BEACON Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the safety and tolerability of briquilimab

Secondary outcome measures

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

BEACON 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jasper Therapeutics, Inc.Lead Sponsor

4 Previous Clinical Trials

128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov's data reflects that this trial is actively recruiting as of now, with its initial posting date being November 29th 2023 and the latest update on December 7th 2023. 44 patients must be enrolled from 1 medical centre in total."

Answered by AI

Does this investigation currently accept participants?

"The clinical trial appears to be recruiting according to the information provided on clinicialtrials.gov. This experiment was initially posted on November 29th 2023, and was most recently amended December 7th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

2023. "Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162728.

All > Chronic Spontaneous Urticaria > Meridian