Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)

Keymed Biosciences

Status and phase

Not yet enrolling

Phase 2

Conditions

Chronic Spontaneous Urticaria (CSU)

Treatments

Drug: placebo

Biological: CM512 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07166211

CM512-112101

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 3 days before screening, 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.