CM512 injection for adults with chronic spontaneous urticaria

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With CSU

This study will test whether injections of CM512 reduce hives and itching in adults with chronic spontaneous urticaria who still have symptoms despite second-generation H1‑antihistamines.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (industry)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07166211 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with chronic spontaneous urticaria for at least 6 months who have moderate to severe symptoms (UAS7 ≥16 and ISS7 ≥8) despite stable second‑generation H1‑antihistamines are ideal candidates.

Not a fit: People who are pregnant, have had prior systemic allergic reactions to biologic products, have previously received CM512, lack adequate washout from recent therapies, or have milder disease (UAS7 <16) are unlikely to benefit from this study.

Why it matters

Potential benefit: If CM512 works, it could reduce hives and itching and offer a new treatment option for people whose CSU is not controlled by antihistamines.

How similar studies have performed: Other biologic treatments for CSU, such as omalizumab, have shown success, but CM512 appears to be a novel agent with limited existing clinical data.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• 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

Conditions: Chronic Spontaneous Urticaria