Effect of briquilimab in patients with patches of itching skin because of chronic spontaneous urticaria (CSU) despite treatment with antihistamines

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Jasper Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

20 Mar 2024 → ongoing

Decision date (initial)

2023-12-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Jasper Therapeutics Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacokinetic

Evaluate the safety and tolerability of briquilimab

Secondary objectives 2

1. Evaluate the preliminary efficacy of briquilimab
2. Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profile of briquilimab

Conditions and MedDRA coding

Chronic Spontaneous Urticaria

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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 and above
3. i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7:Diagnosis of symptomatic CSU despite treatment as defined by: a) Diagnosis of CSU for ≥ 6 months; b) 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); c) 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); d) 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)ii. For Cohorts 8 and 9: Diagnosis of symptomatic CSU despite treatment as defined by: a. Diagnosis of CSU for ≥ 6 months (as per local and international guidance)b. 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) c. Participants may be omalizumab naïve or have been previously exposed to omalizumab independent of treatment duration or response, and require an 8-week washout period prior to the first dose of IP. The 8-week washout is not required for participants who are refractory to omalizumab. Note: Omalizumab-refractory participants are defined as those treated with standard doses of omalizumab (i.e., 300 mg omalizumab every 4 weeks) for at least 3 consecutive months and who had no improvement in CSU, and remained symptomatic resulting in omalizumab discontinuation, as confirmed by investigator assessment. d. UAS7 of ≥ 16 and ISS7 of ≥ 8 on 7 consecutive days between Day -10 through Day -1 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: a) Hemoglobin: ≥ 11 g/dl; b) Platelets: ≥ 100,000/mm3; c) Leucocytes: ≥ 3,000/mm3; d) 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 21

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) 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 during the trial and for at least 150 days after last IP dosing. 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).
17. 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
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence and severity of treatment emergent AEs/SAEs
2. Laboratory assessments ECG, vital signs

Secondary endpoints 6

1. Urticaria Activity Score over 7 days (UAS7); Hive Severity Score over 7 days (HSS7); Itch Severity Score over 7 days (ISS7); Urticaria Control Test (UCT)
2. Complete response rate: Proportion of participants who are urticaria free based on UAS7 = 0.
3. Well-controlled rate: Proportion of participants who are well controlled based on UAS7 ≤ 6 or UCT ≥ 12
4. Time to complete response or well-controlled disease
5. Time to relapse
6. Serum PK concentration of briquilimab over time. Modeled serum PK parameters of briquilimab including but not limited to Cmax, Cmin and AUC as appropriate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Jasper Therapeutics Inc.

Sponsor organisation

Jasper Therapeutics Inc.

Address

2200 Bridge Parkway Suite 102

City

Redwood City

Postcode

94065-1186

Country

United States

Scientific contact point

Organisation

Jasper Therapeutics Inc.

Contact name

Jasper Therapeutics Inc.

Public contact point

Organisation

Jasper Therapeutics Inc.

Contact name

Jasper Therapeutics Inc.

Third parties 16

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications