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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CM512 injection
Biological/Vaccinesubcutaneous injection
placebo
Drugsubcutaneous injection
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 16 weeksSponsors and contacts
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Source ClinicalTrials.gov