Status:
NOT_YET_RECRUITING
Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Chronic Spontaneous Urticaria (CSU)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- Voluntarily sign the Informed Consent Form.
- Age ≥ 18 years old and ≤ 75 years old.
- Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 months.
- Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period.
- A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 3 days before screening, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period.
- Within 7 days before randomization, UAS7≥16 and ISS7 ≥8.
Exclusion
- Not enough washing-out period for previous therapy.
- Planned major surgical procedure during the patient's participation in this study.
- Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients).
- CM512 has been used before.
- Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception.
- With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 14 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07166211
Start Date
September 15 2025
End Date
January 14 2027
Last Update
September 16 2025
Active Locations (1)
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1
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Tianjin, Tianjin Municipality, China