A Phase 2 interventional study of CM512 injection and placebo in Chronic Spontaneous Urticaria (CSU), sponsored by Keymed Biosciences Co.Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Keymed Biosciences Co.Ltd · Phase 2, Interventional, and Treatment
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.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's planned enrollment of 48 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Keymed Biosciences Co.Ltd is the lead sponsor of 68 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: CM512 injection
Drug: placebo
subcutaneous injection
subcutaneous injection
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.
Time frame: Up to 16 weeks
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.
Of 31 phase 2 interventional studies under Chronic Urticaria, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: CM512