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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

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

• 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

⁃ Platelets: ≥ 100,000/mm3

⁃ Leucocytes: ≥ 3,000/mm3

⁃ Neutrophils: ≥ 2,000/mm3

• Willing and able to complete a daily diary for the duration of the trial and adhere to the trial visit schedule

Locations
United States
Alabama
Site 118
RECRUITING
Birmingham
Arkansas
Little Rock Allergy & Asthma Clinical Research Center
RECRUITING
Little Rock
California
Site 117
WITHDRAWN
Fremont
Site 105
RECRUITING
San Diego
Florida
Site 113
RECRUITING
Miami
Site 116
RECRUITING
Tampa
Idaho
Site 109
RECRUITING
Boise
Illinois
Site 124
RECRUITING
Springfield
Indiana
Site 110
RECRUITING
Indianapolis
Kansas
Site 122
RECRUITING
Overland Park
Louisiana
Site 125
WITHDRAWN
Baton Rouge
Site 123
RECRUITING
Lafayette
Maryland
Site 101
RECRUITING
Baltimore
Site 104
RECRUITING
Chevy Chase
Site 121
RECRUITING
White Marsh
Missouri
Site 107
WITHDRAWN
St Louis
Ohio
Site 103
RECRUITING
Cincinnati
Pennsylvania
Site 114
WITHDRAWN
Philadelphia
South Carolina
Site 102
WITHDRAWN
North Charleston
Texas
Site 112
WITHDRAWN
Dallas
Utah
Site 111
RECRUITING
Murray
Washington
Site 115
RECRUITING
Seattle
Other Locations
Germany
Site 201
RECRUITING
Berlin
Site 203
RECRUITING
Bonn
Site 211
RECRUITING
Buxtehude
Site 209
RECRUITING
Dresden
Site 208
RECRUITING
Frankfurt
Site 207
RECRUITING
Hanover
Site 206
RECRUITING
Lübeck
Site 202
RECRUITING
Marburg
Site 210
RECRUITING
München
Site 204
RECRUITING
Münster
Contact Information
Primary
Medical Director
clinicaltrials@jaspertx.com
6505491400
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 80
Treatments
Experimental: 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.
Placebo_comparator: Placebo
Placebo Comparator
Sponsors
Leads: Jasper Therapeutics, Inc.

This content was sourced from clinicaltrials.gov