RECRUITING

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

Conditions

Chronic Spontaneous Urticaria Urticaria Skin Diseases, Vascular Skin Diseases Immune System Diseases Chronic Urticaria Pathologic Processes Chronic Disease Itch Hives Wheals

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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, Or Who Cannot Tolerate Omalizumab

Quick Facts

Study Start:2023-11-29

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06162728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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 Days -10 through Day -3 of Screening (not more than 2 missing entries during that period, re-screening may be considered with Medical Monitor approval) 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	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

Inclusion Criteria

Exclusion 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. 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 Days -10 through Day -3 of Screening (not more than 2 missing entries during that period, re-screening may be considered with Medical Monitor approval)
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

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

Contacts and Locations

Study Contact

Edwin Tucker, MD

CONTACT

6505491400

etucker@jaspertherapeutics.com

Study Locations (Sites)

Site 118

Birmingham, Alabama, 35244

United States

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, 72205

United States

Site 117

Fremont, California, 94538

United States

Site 105

San Diego, California, 92123

United States

Site 113

Miami, Florida, 33165

United States

Site 116

Tampa, Florida, 33613

United States

Site 109

Boise, Idaho, 83706

United States

Site 124

Springfield, Illinois, 61761

United States

Site 110

Indianapolis, Indiana, 46250

United States

Site 122

Overland Park, Kansas, 66210

United States

Site 125

Baton Rouge, Louisiana, 70808

United States

Site 123

Lafayette, Louisiana, 70508

United States

Site 101

Baltimore, Maryland, 21224

United States

Site 104

Chevy Chase, Maryland, 20815

United States

Site 121

White Marsh, Maryland, 21162

United States

Site 107

Saint Louis, Missouri, 63141

United States

Site 103

Cincinnati, Ohio, 45236

United States

Site 114

Philadelphia, Pennsylvania, 19103

United States

Site 102

North Charleston, South Carolina, 29420

United States

Site 112

Dallas, Texas, 75230

United States

Site 111

Murray, Utah, 84107

United States

Site 115

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Jasper Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-11-29

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

Urticaria
Skin Diseases, Vascular
Skin Diseases
Immune System Diseases
Chronic Urticaria
Pathologic Processes
Chronic Disease
Itch
Hives
Wheals

Additional Relevant MeSH Terms

Chronic Spontaneous Urticaria