BRIQUILIMAB for Chronic urticaria

Inclusion criteria

• {"criterion_text":"- Participants must provide informed written consent.\n- Participants must previously have participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event.\n- Disease specific eligibility: a. Participants with CSU have a UAS7 of 16 or greater following the completion of at least 8 weeks of safety follow up in the parent study OR anyone who completed their parent study regardless of UAS7 score. b. Participants with CIndU (cold contact urticaria [ColdU] or symptomatic dermographism) have a UCT of 12 or less following the completion of at least 8 weeks of safety follow up in the parent study OR anyone who completed their parent study regardless of UCT score.\n- The laboratory parameters to be within the acceptable range as follows: a. Hemoglobin: ≥ 10 g/dL b. Platelets: ≥ 100,000/mm3 c. Neutrophils: ≥ 1,500/mm3 d. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × the upper limit of normal (ULN) e. Serum total bilirubin < 2 × ULN, unless attributable to Gilbert’s syndrome f. Estimated creatinine clearance (eCrCl) by the Cockcroft-Gault equation (using total body weight) ≥ 30 mL/min\n- Participants must be willing to abstain from blood donations while being on the trial (Screening to end of trial [EOT]).\n- Male participants (who are not vasectomized) who are heterosexually active must use highly effective contraceptive methods and must abstain from sperm donation during the trial and for at least 8 months after the last dose of briquilimab. 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.\n- Female participants of childbearing potential who are heterosexually active (defined in Section 5.2.1.1 of the protocol) must use highly effective contraceptive methods (Section 5.2.1 of the protocol) during the trial and for at least 90 days after the last dose of briquilimab. Female participants of non-childbearing potential must be surgically sterile (i.e., had undergone complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation) or be in a menopausal state (at least 1 year without menses)."}

Exclusion criteria

• {"criterion_text":"- Partcipants who participated in or who are currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial, are not eligible for this study.\n- Participants with other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, systemic or cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency), are not eligible for this study.\n- Women who are pregnant or nursing or intend to become pregnant during the course of the trial, are not eligible for this study.\n- Participants with any known contraindications or hypersensitivity to any component of briquilimab, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines or leukotrienes are not eligible for this study. Those who have previously experienced an IP-related anaphylactic event, IP-related SAE, or IP-related AE that led to treatment discontinuation in a prior Jasper-sponsored urticaria clinical trial, which in the opinion of the Investigator or medical monitor, may indicate that continued treatment could present an unreasonable risk to the participant are also excluded.\n- Participants with any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or briquilimab administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the participant inappropriate for entry into the trial, are not eligible for this study."}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of adverse events (AEs) including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and adverse events of interest (AEIs). Physical examination findings and standard clinical laboratory parameters.","definition_or_measurement_approach":"Assessment of incidence and severity of AEs/SAEs/TEAEs/AEIs through reported adverse events, physical examination findings and standard clinical laboratory parameters as recorded in study assessments."}

Secondary endpoints

• {"endpoint_text":"- Chronic inducible urticaria {CIndU}: - Change from baseline in critical temperature threshold (CCT) and critical friction threshold (CFT) over time. - Change from Baseline in urticaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time.","definition_or_measurement_approach":"Measured as change from baseline over time in CCT and CFT, change from baseline in UCT, and percentage of participants achieving complete response or well-controlled disease (as defined by study-specific thresholds) over time."}
• {"endpoint_text":"- Chronic spontaneous urticaria {CSU}: - Change from baseline in urticaria activity score over 7 days (UAS7), hive severity score over 7 days (HSS7), itch severity score over 7 days (ISS7), and uricaria control test (UCT) over time. - Percentage of participants with complete response and well-controlled disease over time.","definition_or_measurement_approach":"Measured as change from baseline over time in UAS7, HSS7, ISS7 and UCT, and percentage of participants with complete response or well-controlled disease over time."}

Germany

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

340

Number Of Sites

7

Number Of Participants

45

Primary sponsor

Full Name

Jasper Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: 7

Name

PPD Global Central Labs

Responsibilities

sponsorDuties codes: 15 (Sample storage); 4

Name

Eresearchtechnology Inc.

Responsibilities

sponsorDuties codes: 7

Name

PPD Development LP

Responsibilities

sponsorDuties codes: 1, 10, 12, 13, 2, 3, 4, 5, 6, 7, 8

Name

Eurofins Pharma Bioanalytics Services US Inc.

Responsibilities

sponsorDuties codes: 4

Name

Sherpa Clinical Packaging LLC

Responsibilities

sponsorDuties codes: 14; 15 (Packing / Labelling / Storage site for drug product & Clinical Distribution)

Name

The Doctors Laboratory Limited

Responsibilities

sponsorDuties codes: 4

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 15 (Sample storage); 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1, 10, 12, 13, 2, 3, 4, 5, 6, 7, 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eurofins Pharma Bioanalytics Services US Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"sponsorDuties codes: 14; 15 (Packing / Labelling / Storage site for drug product & Clinical Distribution)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}