Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Chronic Spontaneous Urticaria
Led by Keymed Biosciences Co.Ltd · Updated on 2026-04-09
48
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate CM512 injection in adults with Chronic Spontaneous Urticaria (CSU). The study aims to assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in people who have had CSU for at least six months and continue to experience symptoms despite antihistamine treatment. Participants will receive either CM512 injection or a placebo via subcutaneous injection. All participants must be on a stable dose of second-generation H1-Antihistamines before and during the study. The treatment period lasts up to 16 weeks, during which researchers will monitor changes in urticaria activity scores to evaluate treatment effects. During the study, participants will undergo regular assessments of their urticaria activity using a 7-day score (UAS7). Safety and other response measures will be monitored, including any allergic reactions or side effects. The total participation involves screening, treatment, and follow-up visits over the treatment duration to carefully observe the impact of CM512 compared to placebo.
CONDITIONS
Brief 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 63 18 years old and 64 75 years old.
- Patients with a diagnosis of Chronic Spontaneous Urticaria (CSU) for at least 6 months before screening.
- Pruritus and wheals present for more than 6 weeks before screening despite regular H1-Antihistamines treatment.
- Stable dose of second-generation H1-Antihistamines used continuously for at least 7 days before randomization and willingness to continue stable use during the study.
- Within 7 days before randomization, UAS7 score 63 16 and ISS7 score 63 8.
You will not qualify if you...
- Not enough washing-out period for previous therapy.
- Planned major surgical procedure during participation.
- History of systemic allergic or immediate allergic reaction to any biological product.
- Previous use of CM512.
- Women who are pregnant, breastfeeding, planning to have children during the study, or not agreeing to contraception.
- Any medical or non-medical conditions deemed unsuitable for participation by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 16 weeks
Participants receive subcutaneous injections of CM512 or placebo while continuing stable use of H1-Antihistamines.
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
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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