NCT05452343

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Pruritus of Unknown Origin

Interventions

Type	Name	Description
BIOLOGICAL	CM310	600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks

Timeline

• Start date: 2022-08-30
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-07-11
• Last updated: 2022-07-11