Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)
ConditionChronic Spontaneous Urticaria (CSU)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CM512 injection
- placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov