A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines

Jasper Therapeutics, Inc.5 sites in 1 country27 target enrollmentMarch 18, 2024

ConditionsChronic Inducible Urticaria

InterventionsBriquilimab

DrugsBriquilimab

Overview

Phase: Phase 1
Intervention: Briquilimab
Conditions: Chronic Inducible Urticaria
Sponsor: Jasper Therapeutics, Inc.
Enrollment: 27
Locations: 5
Primary Endpoint: Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines.
Status: Terminated
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore three ascending dose levels which will be tested in three sequential cohorts.

Registry

clinicaltrials.gov

Start Date

March 18, 2024

End Date

July 31, 2025

Last Updated

6 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 obtained from potential participants capable of providing 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
•Diagnosis of ColdU or SD despite the use of H1-antihistamines as defined by all of the following:
•Diagnosis of ColdU or SD for ≥ 3 months, symptoms must comprise both wheal and itch or painful sensation
•Presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)
•ColdU participants must have a positive cold stimulation tests above 4ºC using TempTest® (wheal and itch or painful sensation) on site during Screening to be eligible
•SD participants must have a positive FricTests® with ≥ 3 pins (wheal and itch) on site during Screening to be eligible
•Use of H1-antihistamines on stable dose up to four-fold of the approved dose for at least 4 weeks prior to the Screening visit and not expected to change during first 12 weeks of the trial.
•Participants with chronic spontaneous urticaria (CSU) are eligible if they present with symptoms consistent with ColdU or SD and ColdU or SD is the dominant type of chronic urticaria.
•Blood counts at Screening with:

Exclusion Criteria

•Women who are pregnant or nursing or intend to become pregnant during the course of the trial
•Participants weighing less than 40 kg or more than 125 kg at Screening
•Dominant comorbid chronic urticaria with a clearly defined predominant or sole trigger (chronic inducible urticaria) other than ColdU or SD, including, heat-, solar-, pressure-,delayed pressure-, aquagenic-, cholinergic-, or contact urticaria as well as variants of cold induced urticaria or familial cold autoimmune syndrome except CSU (see inclusion criterion #5)
•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 severe anaphylaxis as defined by Sampson et al. (Section 25.1 ) within 5 years of Screening
•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 or experimental Bruton Tyrosine Kinase (BTK) inhibitors within 5 half-lives prior injection of IP
•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 injection of IP
•ECG findings at Screening that are considered clinically significant

Arms & Interventions

Briquilimab

Cohort 1: Participants will be treated at the trial site with 40 mg briquilimab (Subcutaneous Injection) Cohort 2: Participants will be treated at the trial site with 120 mg briquilimab (Subcutaneous Injection) Cohort 3: Participants will be treated at the trial site with 180 mg briqulimab (Subcutaneous Injection)

Intervention: Briquilimab

Outcomes

Primary Outcomes

Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines.

Time Frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36)

Incidence and severity of treatment emergent AEs/SAEs