A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines and/or Omalizumab, or Who Cannot Tolerate Omalizumab

Jasper Therapeutics, Inc.32 sites in 2 countries88 target enrollmentNovember 29, 2023

ConditionsChronic Spontaneous Urticaria

InterventionsBriquilimab Placebo

Overview

Phase: Phase 1
Intervention: Briquilimab
Conditions: Chronic Spontaneous Urticaria
Sponsor: Jasper Therapeutics, Inc.
Enrollment: 88
Locations: 32
Primary Endpoint: Evaluate the safety and tolerability of briquilimab
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.

Registry

clinicaltrials.gov

Start Date

November 29, 2023

End Date

October 31, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Jasper Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent after the nature of the trial has been fully explained and before performing any trial related assessments
•Males and females, ≥18 years old
•i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7: Diagnosis of symptomatic CSU despite treatment as defined by:
•Diagnosis of CSU for ≥ 6 months
•The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)
•The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite treatment with omalizumab or intolerance to omalizumab (as reported by the participant)
•UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day-1 of Screening
•ii. For Cohorts 8 and 9: Diagnosis of symptomatic CSU despite treatment as defined by:
•Diagnosis of CSU for ≥ 6 months (as per local and international guidance)
•The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)

Exclusion Criteria

•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
•Other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
•Any other active skin disease associated with chronic itching that might confound the trial evaluations and results, in the opinion of the Investigator (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
•History of anaphylaxis
•Any H2 antihistamine, leukotriene receptor antagonist or tricyclic antidepressant use within 3 days prior to Screening
•Experimental monoclonal antibody therapy (e.g., dupilumab, ligelizumab, etc.) within 6 months or Janus kinase (JAK) inhibitors within 5 half-lives prior to first IP dosing
•Immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to first IP dosing
•Electrocardiogram (ECG) findings at Screening that are considered clinically significant
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x Upper limit of normal (ULN) at Screening

Arms & Interventions

Briquilimab

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.

Intervention: Briquilimab

Placebo

Placebo Comparator

Intervention: Placebo

Outcomes

Primary Outcomes

Evaluate the safety and tolerability of briquilimab

Time Frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 48 weeks)

Incidence and severity of treatment emergent AEs/SAEs

Secondary Outcomes

Area under the time-concentration curve from time zero to the last quantifiable concentration (AUClast)(Up to 12 weeks)
Evaluate the preliminary efficacy of briquilimab-- UAS7 Score(Change from baseline to Week 12 and all assessment time points through Week 48)
Maximum serum concentration (Cmax)(Up to 12 weeks)
Time of maximum serum concentration (Tmax)(Up to 12 weeks)
Evaluate the preliminary efficacy of briquilimab - Urticaria Control Test (UCT)(Change from baseline to Week 12 and all assessment time points through Week 48)
Minimum plasma concentration (Cmin)(Up to 12 weeks)