A 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

NCT06353971 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: JSP-CP-0102023-507534-24
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Inducible Urticaria

Keywords

Urticaria; Skin Diseases, Vascular; Skin Diseases; Immune System Diseases; Chronic Urticaria; Itch; Hives; Wheals

Outcome Measures

Primary Outcomes (1)

• 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.

  Incidence and severity of treatment emergent AEs/SAEs

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

Secondary Outcomes (1)

• Preliminary efficacy of briquilimab

  Change from Baseline to all assessment time points through Week 36

Study Arms (1)

Briquilimab

EXPERIMENTAL

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)

Drug: Briquilimab

Interventions

Briquilimab DRUG

Subcutaneous Injection

Also known as: JSP191

Briquilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x Upper limit of normal (ULN) at Screening
• Serum total bilirubin \>1.5 x ULN, unless attributable to Gilbert's syndrome
• Estimated creatinine clearance (eCrCl) by Cockcroft-Gault equation using total body weight \< 60 mL/min
• Known HIV-, hepatitis B-, hepatitis C infection, or acute/long-COVID
• Major abdominal or thoracic surgery within 8 weeks prior to Screening or planned surgery during trial participation
• Male participants (who are not vasectomized) who are not willing to use highly effective contraceptive methods (when having sexual intercourse with a female partner of childbearing potential (Section 9.2) and who are not willing to abstain from sperm donation during the trial and for at least 150 days after last IP dosing. A male participant is considered vasectomized if he had a vasectomy at least 4 months prior to Screening and if he has received post-surgical medical assessment of the surgical success of the vasectomy.

Sponsors & Collaborators

• Jasper Therapeutics, Inc.: lead

Study Sites (5)

Charité - University Clinic Berlin

Berlin, 12203, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

University Clinic Schleswig-Holstein

Lübeck, 23538, Germany

Location

University of Marburg

Marburg, 35043, Germany

Location

University of Munster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Chronic Inducible Urticaria; Urticaria; Skin Diseases, Vascular; Skin Diseases; Immune System Diseases; Chronic Urticaria; Pruritus

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, single ascending dose, Phase 1b/2a trial. Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose. Cohort 3 will be treated with a single 180mg dose.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: March 18, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)