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NCT Number: NCT07166211

Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)

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.

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Key information

Conditions

Chronic Spontaneous Urticaria (CSU) Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM512 injection

Biological

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Change from the baseline in 7-day urticaria activity score (UAS7) at 16 weeks of treatment (W16)

    Time frame: Up to 16 weeks

    UAS7 is a verified and recognized Patient Reported Outcomes(PRO) scale for evaluating the activity of CSU, consisting of 7-day hives-severity score and 7-day itch-severity score (ISS7), ranging from 0 to 42 points. UAS7 score < 7 indicates low urticaria activity, UAS7 score > 28 suggests high urticaria activity and severe condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

86+028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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