Chronic Spontaneous Urticaria (CSU)
Conditions
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.
Interventions
BIOLOGICALCM512 injection
subcutaneous injection
DRUGplacebo
subcutaneous injection
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline in 7-day urticaria activity score (UAS7) at 16 weeks of treatment (W16) | Up to 16 weeks | 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. |
Countries
China
Contacts
CONTACTQian Jia
PRINCIPAL_INVESTIGATORLitao Zhang
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
STUDY_CHAIRZuotao Zhao
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Outcome results
None listed