Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
NCT ID: NCT07166211
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2025-09-15
2027-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
CM512 injection
subcutaneous injection
Group 2
placebo
subcutaneous injection
Interventions
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CM512 injection
subcutaneous injection
placebo
subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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 3 days before screening, 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Litao Zhang
Role: PRINCIPAL_INVESTIGATOR
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Zuotao Zhao
Role: STUDY_CHAIR
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Locations
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Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Other Identifiers
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CM512-112101
Identifier Type: -
Identifier Source: org_study_id
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