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

NCT07166211 | Recruiting Phase 2

• 1 other identifier: CM512-112101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 subjects with CSU.

Conditions

Chronic Spontaneous Urticaria (CSU)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 16 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Biological: CM512 injection

Group 2

PLACEBO COMPARATOR

Drug: placebo

Interventions

CM512 injection BIOLOGICAL

subcutaneous injection

Group 1

placebo DRUG

subcutaneous injection

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Litao Zhang

  Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital

  PRINCIPAL INVESTIGATOR

• Zuotao Zhao

  Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital

  STUDY CHAIR

Central Study Contacts

Qian Jia

CONTACT

86+028-88610620; clinicaltrial@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): January 14, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)