Urticaria ChronicPhase 2NCT06736262
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
A Phase 2 study testing Briquilimab in people with Urticaria Chronic, run by Jasper Therapeutics, Inc. at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urticaria Chronic
- What is being tested?
- Briquilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 26 Nov 2024to 21 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides informed written consent.
- Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
- Disease specific eligibility:
- 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.
- 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.
- The laboratory parameters to be within the acceptable range as follows:
Show all 15Show fewer
- Hemoglobin: ≥ 10 g/dL
- Platelets: ≥ 100,000/mm3
- Neutrophils: ≥ 1,500/mm3
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × the upper limit of normal (ULN)
- Serum total bilirubin < 2 × ULN, unless attributable to Gilbert's syndrome
- Estimated creatinine clearance (eCrCl) by the Cockcroft-Gault equation (using total body weight) ≥ 30 mL/min
- Participants willing to abstain from blood donations while being on the trial (Screening to end of trial [EOT]).
- 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
- 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).
Who cannot join
- Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial.
- 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)
- Women who are pregnant or nursing or intend to become pregnant during the course of the trial
- 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.
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States13 sites
Investigative Site 101
Baltimore, Maryland, 21224
Investigative Site 118
Birmingham, Alabama, 35244
Investigative Site 109
Boise, Idaho, 83706
Investigative Site 103
Cincinnati, Ohio, 45236
Investigative Site 110
Indianapolis, Indiana, 46250
Investigative Site 123
Lafayette, Louisiana, 70508
Investigative Site 108
Little Rock, Arkansas, 72205
Investigative Site 111
Murray, Utah, 84107
Investigative Site 124
Normal, Illinois, 61761
Investigative Site 105
San Diego, California, 92123
Investigative Site 115
Seattle, Washington, 98101
Investigative Site 116
Tampa, Florida, 33613
Investigative Site 121
White Marsh, Maryland, 21162
Germany6 sites
Investigative Site 201
Berlin, 12203
Investigative Site 209
Dresden, Saxony, 01307
Investigative Site 206
Lübeck, Schleswig-Holstein, 23538
Investigative Site 202
Marburg, Hesse, 35043
Investigative Site 210
München, Bavaria, 80802
Investigative Site 204
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Open-Label Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Chronic Urticaria
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.
Read the 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.
- Conditions
- Urticaria Chronic
- Being tested
- Briquilimab
- Keywords
- Itch
- Medical subject headings
- Chronic Urticaria, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BriquilimabDrug
No additional details needed
| Study group | Role | What they receive |
|---|---|---|
| Briquilimab | Experimental | Briquilimab via SQ injection Receives: Drug: Briquilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of briquilimab
Incidence and severity of AEs including SAEs, TEAEs and AEIs.
Measured: From signing the informed consent form through study completion (an average of one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start26 Nov 2024
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Why it stopped: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Jasper Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736262
- Sponsor's protocol ID
- JSP-CP-014
- Other IDs
- 2024-517830-17-00
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Chronic Urticaria
- ClinicalTrials.gov ID
- NCT06736262
- Acronym / sponsor ID
- JSP-CP-014
- Conditions
- Urticaria Chronic
- Keywords
- Itch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Jasper Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Briquilimab | Experimental | Drug: BriquilimabBriquilimab via SQ injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provides informed written consent.
- Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
- Disease specific eligibility:
- The laboratory parameters to be within the acceptable range as follows:
- Participants willing to abstain from blood donations while being on the trial (Screening to end of trial [EOT]).
Key exclusion criteria (5 listed)
- Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial.
- 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)
- Women who are pregnant or nursing or intend to become pregnant during the course of the trial
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BriquilimabNo additional details needed | Drug | Briquilimab |
Primary outcome
To evaluate the safety and tolerability of briquilimab
Time frame: From signing the informed consent form through study completion (an average of one year)
Incidence and severity of AEs including SAEs, TEAEs and AEIs.
Results and safety
The study was stopped early (reason given: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Jasper Therapeutics
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Briquilimab in people with Urticaria Chronic, run by Jasper Therapeutics, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of briquilimab (time frame: From signing the informed consent form through study completion (an average of one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.