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

NCT06162728 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: JSP-CP-0112023-505446-25
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 23

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.

Conditions

Chronic Spontaneous Urticaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of briquilimab

  Incidence and severity of treatment emergent AEs/SAEs

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

Secondary Outcomes (6)

• Evaluate the preliminary efficacy of briquilimab-- UAS7 Score

  Change from baseline to Week 12 and all assessment time points through Week 48

• Evaluate the preliminary efficacy of briquilimab - Urticaria Control Test (UCT)

  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

• Minimum plasma concentration (Cmin)

  Up to 12 weeks

Study Arms (2)

Briquilimab

EXPERIMENTAL

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.

Drug: Briquilimab

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Other: Placebo

Interventions

Briquilimab DRUG

Subcutaneous Administration

Also known as: JSP191

Briquilimab

Placebo OTHER

Placebo Comparator

Placebo

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 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)
• Participants may be omalizumab naïve or have been previously exposed to omalizumab independent of treatment duration or response
• UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day -1 of Screening
• Use of H1-antihistamines on stable dose up to four-fold of the approved dose since Screening and not expected to change during first 12 weeks of the trial
• Blood counts at Screening with:
• Hemoglobin: ≥ 11 g/dl

You may not qualify if:

• 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
• 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+, active hepatitis B or 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 8.2) 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 (23)

Site 118

Birmingham, Alabama, 35244, United States

Location

Site 108

Little Rock, Arkansas, 72205, United States

Location

Site 105

San Diego, California, 92123, United States

Location

Site 113

Miami, Florida, 33165, United States

Location

Site 116

Tampa, Florida, 33613, United States

Location

Site 109

Boise, Idaho, 83706, United States

Location

Site 124

Springfield, Illinois, 61761, United States

Location

Site 110

Indianapolis, Indiana, 46250, United States

Location

Site 122

Overland Park, Kansas, 66210, United States

Location

Site 123

Lafayette, Louisiana, 70508, United States

Location

Site 101

Baltimore, Maryland, 21224, United States

Location

Site 104

Chevy Chase, Maryland, 20815, United States

Location

Site 121

White Marsh, Maryland, 21162, United States

Location

Site 103

Cincinnati, Ohio, 45236, United States

Location

Site 111

Murray, Utah, 84107, United States

Location

Site 115

Seattle, Washington, 98101, United States

Location

Site 201

Berlin, Germany

Location

Site 211

Buxtehude, Germany

Location

Site 209

Dresden, Germany

Location

Site 206

Lübeck, Germany

Location

Site 202

Marburg, Germany

Location

Site 210

München, Germany

Location

Site 204

Münster, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Skin Diseases; Immune System Diseases; Pathologic Processes; Chronic Disease; Pruritus

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Jasper Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be performed as a three-part dose escalating clinical trial where Part 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Cohorts 1 and 2, 3+3 dose escalation design Cohorts 1 through 9 will be enrolled sequentially in a dose escalating fashion starting from the lowest dose proposed. The Treatment Period in Part 2 (Cohorts 3, 4, 5, 8, and 9) and Part 3 (Cohort 6 and 7) will be performed in a double-blind, placebo-controlled manner.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 8, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); DE (7)