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Testing Briquilimab for Chronic Spontaneous Urticaria

A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients with Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment with H1 Antihistamines And/or Omalizumab, or Who Cannot Tolerate Omalizumab

Phase1; Phase2 Interventional Jasper Therapeutics, Inc. · NCT06162728

This study is testing a new treatment called briquilimab to see if it can help adults with chronic spontaneous urticaria who haven't found relief with standard medications.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorJasper Therapeutics, Inc. Industry-sponsored
Drugs / interventionsomalizumab, dupilumab, ligelizumab, methotrexate, cyclophosphamide, briquilimab
Locations32 sites (Birmingham, Alabama and 31 other locations)
Trial IDNCT06162728 on ClinicalTrials.gov

What this trial studies

This clinical trial is a three-part dose escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of briquilimab in adult patients suffering from chronic spontaneous urticaria (CSU) who have not responded adequately to standard treatments. The first part of the trial is open label, while the second and third parts are randomized, double-blinded, and placebo-controlled. The study will also investigate the pharmacokinetic properties of briquilimab and its effects on mast cells and allergic skin reactivity. Participants will be closely monitored for their symptoms and response to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic spontaneous urticaria for at least six months, experiencing persistent symptoms despite treatment with H1-antihistamines and omalizumab.

Not a fit: Patients who have not been diagnosed with chronic spontaneous urticaria or those who have not tried H1-antihistamines or omalizumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with chronic spontaneous urticaria who do not respond to existing therapies.

How similar studies have performed: Other studies have shown promise in treating chronic spontaneous urticaria with novel therapies, but the specific approach of briquilimab is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Written informed consent after the nature of the trial has been fully explained and before performing any trial related assessments
2. Males and females, ≥18 years old
3. i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7: Diagnosis of symptomatic CSU despite treatment as defined by:

   1. Diagnosis of CSU for ≥ 6 months
   2. The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)
   3. The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite treatment with omalizumab or intolerance to omalizumab (as reported by the participant)
   4. UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day-1 of Screening

   ii. For Cohorts 8 and 9: Diagnosis of symptomatic CSU despite treatment as defined by:
   1. Diagnosis of CSU for ≥ 6 months (as per local and international guidance)
   2. The presence of itch and hives for ≥ 8 consecutive weeks at any time prior to Screening despite current use of H1-antihistamines (as reported by the participant)
   3. Participants may be omalizumab naïve or have been previously exposed to omalizumab independent of treatment duration or response
   4. UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day -1 of Screening
4. Use of H1-antihistamines on stable dose up to four-fold of the approved dose since Screening and not expected to change during first 12 weeks of the trial
5. Blood counts at Screening with:

   1. Hemoglobin: ≥ 11 g/dl
   2. Platelets: ≥ 100,000/mm3
   3. Leucocytes: ≥ 3,000/mm3
   4. Neutrophils: ≥ 2,000/mm3
6. Willing and able to complete a daily diary for the duration of the trial and adhere to the trial visit schedule

Exclusion Criteria:

1. Women who are pregnant or nursing or intend to become pregnant during the course of the trial
2. Dominant comorbid chronic urticaria with a clearly defined predominant or sole trigger (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria
3. 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)
4. 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.)
5. History of anaphylaxis
6. Any H2 antihistamine, leukotriene receptor antagonist or tricyclic antidepressant use within 3 days prior to Screening
7. Experimental monoclonal antibody therapy (e.g., dupilumab, ligelizumab, etc.) within 6 months or Janus kinase (JAK) inhibitors within 5 half-lives prior to first IP dosing
8. 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 first IP dosing
9. Electrocardiogram (ECG) findings at Screening that are considered clinically significant
10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x Upper limit of normal (ULN) at Screening
11. Serum total bilirubin \>1.5 x ULN, unless attributable to Gilbert's syndrome
12. Estimated creatinine clearance (eCrCl) by Cockcroft-Gault equation using total body weight \< 60 mL/min
13. Known HIV+, active hepatitis B or hepatitis C infection, or acute/long-COVID
14. Major abdominal or thoracic surgery within 8 weeks prior to Screening or planned surgery during trial participation
15. 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 8.2) 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.
16. Female participants of childbearing potential not willing to use highly effective contraceptive methods (Section 8.2) during the trial and for at least 150 days after last IP dosing. Women of nonchildbearing 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).
17. Participation in another research trial involving the use of an IP within the last 30 days (or 5 halflives of IP, whichever is longer) prior to Screening
18. Any known contraindications or hypersensitivity to any component of the IP, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines or leukotrienes
19. 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
20. Participants not willing to abstain from blood donations while being on the trial (until EOT Visit)
21. 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

Where this trial is running

Birmingham, Alabama and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Spontaneous UrticariaUrticariaSkin Diseases, VascularSkin DiseasesImmune System DiseasesChronic UrticariaPathologic ProcessesChronic Disease
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.