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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Jasper Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

14 Mar 2025 → ongoing

Decision date (initial)

2025-02-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Jasper Therapeutics Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Efficacy

To evaluate the safety and tolerability of briquilimab

Secondary objectives 1

1. To evaluate the clinical activity of briquilimab

Conditions and MedDRA coding

Chronic Urticaria

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participants must provide informed written consent.
2. 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.
3. 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.
4. 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
5. Participants must be 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 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 5

1. 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.
2. 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.
3. Women who are pregnant or nursing or intend to become pregnant during the course of the trial, are not eligible for this study.
4. 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.
5. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Jasper Therapeutics Inc.

Sponsor organisation

Jasper Therapeutics Inc.

Address

2200 Bridge Parkway Suite 102

City

Redwood City

Postcode

94065-1186

Country

United States

Scientific contact point

Organisation

Jasper Therapeutics Inc.

Contact name

Edwin Tucker (Chief Medical Officer)

Public contact point

Organisation

Jasper Therapeutics Inc.

Contact name

Patricia Carlos

Third parties 7

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications