CM512 injection for 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 randomized, double-blind, placebo-controlled phase II trial designed to test the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in adults with chronic spontaneous urticaria. Eligible participants are adults aged 18–75 with at least 6 months of CSU and active symptoms despite stable second‑generation H1‑antihistamine therapy, including UAS7 ≥16 and ISS7 ≥8. Participants will be randomized to receive CM512 injection or placebo while continuing stable background antihistamine therapy, and outcomes will include symptom scores, safety measures, PK/PD sampling, and antibody testing. Major exclusions include prior CM512 exposure, prior severe allergic reactions to biologic products, insufficient washout of other therapies, planned major surgery, and pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 7 days before randomization, 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 Criteria:

* 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.

Where it's running

• Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Litao Zhang — Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
• Study coordinator: Qian Jia
• Email: clinicaltrial@keymedbio.com
• Phone: 86+028-88610620

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.