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

Status: Terminated
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ Hemoglobin: ≥ 11 g/dl

⁃ Platelets: ≥ 100,000/mm3

⁃ Leucocytes: ≥ 3,000/mm3

⁃ Neutrophils: ≥ 2,000/mm3

• Willing and able to participate and adhere to the trial visits schedule.

Locations
Other Locations
Germany
Charité - University Clinic Berlin
Berlin
University Hospital Dresden
Dresden
University Clinic Schleswig-Holstein
Lübeck
University of Marburg
Marburg
University of Munster
Münster
Time Frame
Start Date: 2024-03-18
Completion Date: 2025-07-31
Participants
Target number of participants: 27
Treatments
Experimental: 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)
Related Therapeutic Areas
Sponsors
Leads: Jasper Therapeutics, Inc.

This content was sourced from clinicaltrials.gov