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Chronic Inducible UrticariaPhase 1/2SPOTLIGHTNCT06353971

A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines

A Phase 1/2 study testing Briquilimab in people with Chronic Inducible Urticaria, run by Jasper Therapeutics, Inc. at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Inducible Urticaria
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
27 participants
Where
5 sitesGermany
Study dates
18 Mar 2024to 31 Jul 2025
Phase
Phase 1/2
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

  • Written informed consent obtained from potential participants capable of providing 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
  • Diagnosis of ColdU or SD despite the use of H1-antihistamines as defined by all of the following:
  • Diagnosis of ColdU or SD for ≥ 3 months, symptoms must comprise both wheal and itch or painful sensation
  • Presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)
  • ColdU participants must have a positive cold stimulation tests above 4ºC using TempTest® (wheal and itch or painful sensation) on site during Screening to be eligible
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  • SD participants must have a positive FricTests® with ≥ 3 pins (wheal and itch) on site during Screening to be eligible
  • Use of H1-antihistamines on stable dose up to four-fold of the approved dose for at least 4 weeks prior to the Screening visit and not expected to change during first 12 weeks of the trial.
  • Participants with chronic spontaneous urticaria (CSU) are eligible if they present with symptoms consistent with ColdU or SD and ColdU or SD is the dominant type of chronic urticaria.
  • 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 participate and adhere to the trial visits schedule.

Who cannot join

  • Women who are pregnant or nursing or intend to become pregnant during the course of the trial
  • Participants weighing less than 40 kg or more than 125 kg at Screening
  • Dominant comorbid chronic urticaria with a clearly defined predominant or sole trigger (chronic inducible urticaria) other than ColdU or SD, including, heat-, solar-, pressure-,delayed pressure-, aquagenic-, cholinergic-, or contact urticaria as well as variants of cold induced urticaria or familial cold autoimmune syndrome except CSU (see inclusion criterion #5)
  • Other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
  • Any other active skin disease associated with chronic itching that might confound the trial evaluations and results in the opinion of the Investigator (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
  • History of severe anaphylaxis as defined by Sampson et al. (Section 25.1 ) within 5 years of Screening
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  • Any H2 antihistamine, leukotriene receptor antagonist or tricyclic antidepressant use within 3 days prior to Screening
  • Experimental monoclonal antibody therapy (e.g., dupilumab, ligelizumab, etc.) within 6 months or Janus kinase (JAK) inhibitors or experimental Bruton Tyrosine Kinase (BTK) inhibitors within 5 half-lives prior injection of IP
  • Immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to injection of IP
  • ECG findings at Screening that are considered clinically significant
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x Upper limit of normal (ULN) at Screening
  • Serum total bilirubin >1.5 x ULN, unless attributable to Gilbert's syndrome
  • Estimated creatinine clearance (eCrCl) by Cockcroft-Gault equation using total body weight < 60 mL/min
  • Known HIV-, hepatitis B-, hepatitis C infection, or acute/long-COVID
  • Major abdominal or thoracic surgery within 8 weeks prior to Screening or planned surgery during trial participation
  • Male participants (who are not vasectomized) who are not willing to use highly effective contraceptive methods (when having sexual intercourse with a female partner of childbearing potential (Section 9.2) and who are not willing to abstain from sperm donation during the trial and for at least 150 days after last IP dosing. 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 not willing to use highly effective contraceptive methods (Section 9.2) during the trial and for at least 150 days after IP dosing in case of early withdrawal. Women of non-childbearing potential, must be surgically sterile (i.e., had undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or be in menopausal state (at least 1 year without menses).
  • Participation in another research trial involving the use of an IP within the last 30 days (or 5 half-lives of IP, whichever is longer) prior to Screening
  • Any known contraindications or hypersensitivity to any component of IPs, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines, leukotrienes
  • Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or IP 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
  • Participants not willing to abstain from blood donations while being on the trial (Screening to EOT)
  • Close affiliation with the Investigator (e.g., a close relative, financially dependent on the trial site) or participant who is an employee of the Sponsor's company

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Charité - University Clinic Berlin

    Berlin, 12203

  • University Hospital Dresden

    Dresden, 01307

  • University Clinic Schleswig-Holstein

    Lübeck, 23538

  • University of Marburg

    Marburg, 35043

  • University of Munster

    Münster, 48149

Other trials in Germany

About this study

Official title: A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines

This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore three ascending dose levels which will be tested in three sequential cohorts.

Being tested
Briquilimab
Keywords
Urticaria, Skin Diseases, Vascular, Skin Diseases, Immune System Diseases, Chronic Urticaria, Itch, Hives, Wheals
Medical subject headings
Chronic Inducible Urticaria, Urticaria, Skin Diseases, Vascular, Skin Diseases, Immune System Diseases, Chronic Urticaria, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BriquilimabDrug

    Also called JSP191

    Subcutaneous Injection

Study groups in NCT06353971
Study groupRoleWhat they receive
BriquilimabExperimentalCohort 1: Participants will be treated at the trial site with 40 mg briquilimab (Subcutaneous Injection) Cohort 2: Participants will be treated at the trial site with 120 mg briquilimab (Subcutaneous Injection) Cohort 3: Participants will be treated at the trial site with 180 mg briqulimab (Subcutaneous Injection)
Receives: Drug: Briquilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines.

    Incidence and severity of treatment emergent AEs/SAEs

    Measured: From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36)

Secondary outcomes (1)

  1. Preliminary efficacy of briquilimab

    Provocation testing:

    ColdU: Critical temperature threshold (CCT) SD: Critical friction threshold (CFT)

    Measured: Change from Baseline to all assessment time points through Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start18 Mar 2024
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Why it stopped: Enrollment was completed and primary efficacy endpoint was completed. Study was terminated before safety follow up was completed due to changes in company priorities and not related to safety concerns

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is an open-label, single ascending dose, Phase 1b/2a trial. Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose. Cohort 3 will be treated with a single 180mg dose.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353971
Sponsor's protocol ID
JSP-CP-010
Other IDs
2023-507534-24, 2023
Acronym
SPOTLIGHT
Status last verified
Sep 2025
First submitted
3 Apr 2024
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Briquilimab in people with Chronic Inducible Urticaria, run by Jasper Therapeutics, Inc. at 5 sites in Germany.

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 22 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Enrollment was completed and primary efficacy endpoint was completed. Study was terminated before safety follow up was completed 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?

Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. (time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06353971.

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 8 Oct 2025.

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