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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505446-25-00

Acronym

JSP-CP-011

Enrollment

Registered

2023-12-19

Start date

2024-03-20

Completion date

Unknown

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria

Brief summary

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

Detailed description

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), Complete response rate: Proportion of participants who are urticaria free based on UAS7 = 0., Well-controlled rate: Proportion of participants who are well controlled based on UAS7 ≤ 6 or UCT ≥ 12, Time to complete response or well-controlled disease, Time to relapse, Serum PK concentration of briquilimab over time. Modeled serum PK parameters of briquilimab including but not limited to Cmax, Cmin and AUC as appropriate

Interventions

DRUGEPINEPHRINE

DRUGBriquilimab

DRUGPlacebo (10 mM sodium acetate

DRUG9.0% (w/v) sucrose

DRUG0.02% (w/v) polysorbate 20

DRUGpH 5.2)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of treatment emergent AEs/SAEs, Laboratory assessments ECG, vital signs	—

Secondary

Measure	Time frame
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), Complete response rate: Proportion of participants who are urticaria free based on UAS7 = 0., Well-controlled rate: Proportion of participants who are well controlled based on UAS7 ≤ 6 or UCT ≥ 12, Time to complete response or well-controlled disease, Time to relapse, Serum PK concentration of briquilimab over time. Modeled serum PK parameters of briquilimab including but not limited to Cmax, Cmin and AUC as appropriate	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026