Clinical trial NCT06736262: A Phase 2, Open-Label, Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Participants From Jasper-Sponsored Chronic Urticaria Trials
Official title: Open-Label Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Chronic Urticaria
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Urticaria Chronic
Keywords: Itch
Lead sponsor: Jasper Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.

Detailed description: This is a Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial, specifically the BEACON (JSP-CP-011) and SPOTLIGHT (JSP CP-010) trials (referred to as "parent studies") and future CU trials sponsored by Jasper Therapeutics.

Eligibility criteria: Inclusion Criteria:

1. Provides informed written consent.
2. Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
3. Disease specific eligibility:

   1. 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.
   2. 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.
4. The laboratory parameters to be within the acceptable range as follows:

   1. Hemoglobin: ≥ 10 g/dL
   2. Platelets: ≥ 100,000/mm3
   3. Neutrophils: ≥ 1,500/mm3
   4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 × the upper limit of normal (ULN)
   5. Serum total bilirubin \< 2 × ULN, unless attributable to Gilbert's syndrome
   6. Estimated creatinine clearance (eCrCl) by the Cockcroft-Gault equation (using total body weight) ≥ 30 mL/min
5. Participants willing to abstain from blood donations while being on the trial (Screening to end of trial \[EOT\]).
6. 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
7. Female participants of childbearing potential who are heterosexually active (defined in Section 5.2.1.1) must use highly effective contraceptive methods (Section 5.2.1) 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 oophorectomy, or bilateral tubal ligation) or be in a menopausal state (at least 1 year without menses).

Exclusion Criteria:

1. Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial.
2. 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)
3. Women who are pregnant or nursing or intend to become pregnant during the course of the trial
4. 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. 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.
5. 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of briquilimab
timeFrame: From signing the informed consent form through study completion (an average of one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site 118
state: Alabama
city: Little Rock
country: United States
facility: Investigative Site 108
state: Arkansas
city: San Diego
country: United States
facility: Investigative Site 105
state: California
city: Tampa
country: United States
facility: Investigative Site 116
state: Florida
city: Boise
country: United States
facility: Investigative Site 109
state: Idaho
city: Normal
country: United States
facility: Investigative Site 124
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Site 110
state: Indiana
city: Lafayette
country: United States
facility: Investigative Site 123
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site 101
state: Maryland
city: White Marsh
country: United States
facility: Investigative Site 121
state: Maryland
city: Cincinnati
country: United States
facility: Investigative Site 103
state: Ohio
city: Murray
country: United States
facility: Investigative Site 111
state: Utah
city: München
country: Germany
facility: Investigative Site 210
state: Bavaria
city: Marburg
country: Germany
facility: Investigative Site 202
state: Hesse
city: Münster
country: Germany
facility: Investigative Site 204
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: Investigative Site 209
state: Saxony
city: Lübeck
country: Germany
facility: Investigative Site 206
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Investigative Site 201
Study officials:
affiliation: Jasper Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: