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Chronic Spontaneous UrticariaPhase 1/2BEACONNCT06162728

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

A Phase 1/2 study testing Briquilimab in people with Chronic Spontaneous Urticaria, run by Jasper Therapeutics, Inc. at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled. The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
Briquilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
23 sitesin 2 countries
Study dates
29 Nov 2023to 8 Jul 2026
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 after the nature of the trial has been fully explained and before performing any trial related assessments
  • Males and females, ≥18 years old
  • i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7: Diagnosis of symptomatic CSU despite treatment as defined by:
  • Diagnosis of CSU for ≥ 6 months
  • 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)
  • 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)
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  • UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day-1 of Screening
  • For Cohorts 8 and 9: Diagnosis of symptomatic CSU despite treatment as defined by:
  • Diagnosis of CSU for ≥ 6 months (as per local and international guidance)
  • 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)
  • Participants may be omalizumab naïve or have been previously exposed to omalizumab independent of treatment duration or response
  • UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day -1 of Screening
  • 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
  • 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 complete a daily diary for the duration of the trial and adhere to the trial visit schedule

Who cannot join

  • Women who are pregnant or nursing or intend to become pregnant during the course of the trial
  • 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
  • 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 anaphylaxis
  • Any H2 antihistamine, leukotriene receptor antagonist or tricyclic antidepressant use within 3 days prior to Screening
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  • 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
  • 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
  • Electrocardiogram (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+, active hepatitis B or 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 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.
  • 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).
  • 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
  • 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
  • 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 (until EOT Visit)
  • 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

23 sites in 2 countries.

23 sites in 2 countries

United States16 sites

  • Site 101

    Baltimore, Maryland, 21224

  • Site 118

    Birmingham, Alabama, 35244

  • Site 109

    Boise, Idaho, 83706

  • Site 104

    Chevy Chase, Maryland, 20815

  • Site 103

    Cincinnati, Ohio, 45236

  • Site 110

    Indianapolis, Indiana, 46250

  • Site 123

    Lafayette, Louisiana, 70508

  • Site 108

    Little Rock, Arkansas, 72205

  • Site 113

    Miami, Florida, 33165

  • Site 111

    Murray, Utah, 84107

  • Site 122

    Overland Park, Kansas, 66210

  • Site 105

    San Diego, California, 92123

  • Site 115

    Seattle, Washington, 98101

  • Site 124

    Springfield, Illinois, 61761

  • Site 116

    Tampa, Florida, 33613

  • Site 121

    White Marsh, Maryland, 21162

Other trials in United States

Germany7 sites

  • Site 201

    Berlin

  • Site 211

    Buxtehude

  • Site 209

    Dresden

  • Site 206

    Lübeck

  • Site 202

    Marburg

  • Site 210

    München

  • Site 204

    Münster

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 Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines and/or Omalizumab, or Who Cannot Tolerate Omalizumab

This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.

The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.

Being tested
Briquilimab, Placebo
Keywords
Urticaria, Skin Diseases, Vascular, Skin Diseases, Immune System Diseases, Chronic Urticaria, Pathologic Processes, Chronic Disease, Itch, Hives, Wheals
Medical subject headings
Chronic Urticaria, Urticaria, Skin Diseases, Vascular, Skin Diseases, Immune System Diseases, Pathologic Processes, Chronic Disease, 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 Administration

  • PlaceboOther

    Placebo Comparator

Study groups in NCT06162728
Study groupRoleWhat they receive
BriquilimabExperimentalThis trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
Receives: Drug: Briquilimab
PlaceboPlacebo comparatorPlacebo Comparator
Receives: Other: Placebo

What is being measured

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

  1. Evaluate the safety and tolerability of briquilimab

    Incidence and severity of treatment emergent AEs/SAEs

    Measured: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 48 weeks)

Secondary outcomes (6)

  1. Evaluate the preliminary efficacy of briquilimab-- UAS7 Score

    UAS7 is the sum of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS) for seven consecutive days. The possible range of the weekly UAS7 score is 0 - 42.

    Measured: Change from baseline to Week 12 and all assessment time points through Week 48

  2. Evaluate the preliminary efficacy of briquilimab - Urticaria Control Test (UCT)

    The UCT score is derived by adding up the scores from each of the four questions. A total score from 0 (no control) to 16 points (complete control) is derived, with a score of ≥ 12 indicating well-controlled disease.

    Measured: Change from baseline to Week 12 and all assessment time points through Week 48

  3. Maximum serum concentration (Cmax)

    Maximum serum concentration (Cmax) following a single dose of briquilimab.

    Measured: Up to 12 weeks

  4. Time of maximum serum concentration (Tmax)

    Time of maximum serum concentration (Tmax) following a single dose of briquilimab

    Measured: Up to 12 weeks

  5. Minimum plasma concentration (Cmin)

    Minimum serum concentration (Cmin) following a single dose of briquilimab

    Measured: Up to 12 weeks

  6. Area under the time-concentration curve from time zero to the last quantifiable concentration (AUClast)

    Area under the time-concentration curve from time zero to the last quantifiable concentration (AUClast) following a single dose of briquilimab

    Measured: Up to 12 weeks

Timeline

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

  1. First posted8 Dec 2023
  2. Study start29 Nov 2023
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

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
Randomised
Intervention model
Sequential
Model description
Part 1: Cohorts 1 and 2, 3+3 dose escalation design Cohorts 1 through 9 will be enrolled sequentially in a dose escalating fashion starting from the lowest dose proposed. The Treatment Period in Part 2 (Cohorts 3, 4, 5, 8, and 9) and Part 3 (Cohort 6 and 7) will be performed in a double-blind, placebo-controlled manner.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162728
Sponsor's protocol ID
JSP-CP-011
Other IDs
2023-505446-25, 2023
Acronym
BEACON
Status last verified
Aug 2026
First submitted
21 Nov 2023
Last updated
6 Aug 2026
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 Spontaneous Urticaria, run by Jasper Therapeutics, Inc. at 23 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 19 inclusion and 21 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: finished, 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 23 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate the safety and tolerability of briquilimab (time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 48 weeks)). 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 NCT06162728.

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.

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