Actively Recruiting
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
Led by Keymed Biosciences Co.Ltd · Updated on 2026-04-09
48
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
CONDITIONS
Official Title
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the Informed Consent Form.
- Age 18 years or older and 75 years or younger.
- Diagnosis of chronic spontaneous urticaria for at least 6 months before screening.
- Experiencing itching and wheals for more than 6 weeks despite regular H1-antihistamines treatment.
- Using a stable dose of second-generation H1-antihistamines continuously for at least 7 days before randomization and willing to continue during the study.
- Urticaria Activity Score over 7 days (UAS7) of 16 or higher and Investigator's Static Global Assessment (ISS7) of 8 or higher within 7 days before randomization.
You will not qualify if you...
- Insufficient washout period for previous therapy.
- Planned major surgery during participation.
- History of systemic or immediate allergic reaction to any biological product.
- Prior use of CM512.
- Pregnant or breastfeeding women, those planning to have children during the study, or not agreeing to contraception.
- Any medical or non-medical condition deemed unsuitable by investigators for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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