NCT07166211 Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
| NCT ID | NCT07166211 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Chronic Spontaneous Urticaria (CSU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-11-27 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Litao Zhang
PRINCIPAL INVESTIGATOR
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Frequently Asked Questions
Who can join the NCT07166211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Spontaneous Urticaria (CSU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07166211 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07166211 currently recruiting?
Yes, NCT07166211 is actively recruiting participants. Contact the research team at clinicaltrial@keymedbio.com for enrollment information.
Where is the NCT07166211 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07166211 clinical trial?
NCT07166211 is sponsored by Keymed Biosciences Co.Ltd. The principal investigator is Litao Zhang at Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital. The trial plans to enroll 48 participants.