A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BBT001, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Adult Patients With Chronic Spontaneous Urticaria.
Overview
This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.
Detailed description
The study consists of below cohorts:
Cohort A1 (biologic-naïve): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A2 (biologic-experienced): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A3 (biologic-naïve) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4) Cohort A4 (biologic-experienced) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4)
Interventions
- Drug BBT001
BBT001 will be administered - Drug Placebo
Placebo will be administered
Primary outcome measures
- Number of participants with adverse events following multiple administration of BBT001 [Time frame: - Up to Day 183 post first dose administration]
- Number of participants with change in vital sign measurements following treatment administration. [Time frame: Up to Day 183 post first dose administratio]
- Number of participants with change in serum blood parameters. [Time frame: Up to Day 183 post first dose administration]
- Number of participants with change in physical examination following treatment administration [Time frame: Up to Day 183 post first dose administration]
- Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration. [Time frame: Up to Day 183 post first dose administration]
Secondary outcome measures (7)
- Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax) [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]]
- Pharmacokinetics parameters- Area under the curve (AUC) [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
- Pharmacokinetics parameters- Volume of distribution (Vz) [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
- Pharmacokinetics parameters- maximum observed Concentration (Cmax) [Time frame: specified timepoints pre-dose and up to 183 days post first dose administration]
- Pharmacokinetics parameters- Total clearance (CL) [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
- Pharmacokinetics parameters- - Elimination Half-life (t1/2). [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
- The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). [Time frame: At specified timepoints pre-dose and up to 183 days post first dose administration]
Eligibility criteria
Inclusion Criteria: key inclusion criteria: 1)Male or female 18 to 75 years (inclusive) of age at time of consent. 2)Capped weight to be no more than 125 kg at screening.3)UAS7>=16; 4)Patients must have been on daily stable doses of H1-AH;5) Written informed consent obtained from the participant prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization.
Exclusion Criteria: key exclusion criteria: 1）Inducible urticaria ; 2） Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis ；3） Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes; 4)History of herpes simplex infection; 5 ）Serological abnormalities of infection at screening .
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 10 centers
- The Second Affiliated Hospital of Wannan Medical College — Wuhu
- Peking University People's Hospital, Beijing — Beijing
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
- Dermatology Hospital of Southern Medical University — Guangzhou
- The First Hospital of Hebei Medical University — Shijiazhuang
- Jingzhou Central Hospital — Jinzhou
- Wuxi Second People's Hospital, — Wuxi
- The Second Hospital of Shanxi Medical University — Taiyuan
- … and 2 more centers
Identifiers
NCT: NCT07717905 · BBT001-004