A Study of CM310 in Subjects With Chronic Pruritus
Phase 2
- Conditions
- Chronic Pruritus of Unknown Origin
- Interventions
- Biological: CM310
- Registration Number
- NCT05452343
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CM310 CM310 600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks Placebo CM310 once every two weeks
- Primary Outcome Measures
Name Time Method Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS) at week 16 Change from baseline in the worst itching numerical rating scale at week 16
- Secondary Outcome Measures
Name Time Method Safety parameters Baseline up to Week 24 Incidence of treatment-emergent adverse events (TEAEs).