A Study of CM310 in Subjects With Chronic Pruritus

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Chronic Pruritus of Unknown Origin

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.

The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks).

50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.

Inclusion Criteria:

• Age ≥ 18 years old.
• With chronic pruritus of unknown origin.
• With the worst pruritus numerical rating scale (WI-NRS) ≥7.
• Contraception.

Exclusion Criteria:

• Heavy drinking in the 3 months prior to screening.
• With severe hepatic and renal impairment.
• Previous history of autosensitivity dermatitis.
• Allergic to CM310/placebo.
• Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.