BBT001 in adults with chronic spontaneous urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2a randomized, blinded, placebo-controlled study evaluating multiple ascending doses of BBT001 in adults with chronic spontaneous urticaria. Participants are assigned to receive either BBT001 at 450 mg or 900 mg or placebo, with cohorts including biologic-naïve and biologic-experienced individuals. The study assesses safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity, with optional cohorts to expand dosing and experience. Enrolled sites are in China and include major hospitals in Wuhu, Beijing, and Guangzhou. Primary goals focus on safety and early signals of efficacy to guide further development.

Why it matters

Who can join: the full rules

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 .

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Where it's running

• Peking University People's Hospital, Beijing
  Beijing, Beijing Municipality, China Recruiting
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Not yet recruiting
• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Dermatology Hospital of Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The First Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting
• Jingzhou Central Hospital
  Jinzhou, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Tracy Ji, Study Director
• Email: tracy.ji@bambusatx.com
• Phone: +86 18001322760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.