A Study of CM310 in Subjects With Chronic Pruritus

Keymed Biosciences Co.Ltd50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Pruritus of Unknown Origin

Interventions

CM310BIOLOGICAL

600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)

Change from baseline in the worst itching numerical rating scale at week 16

Time frame: at week 16

Secondary Outcomes

Safety parameters

Incidence of treatment-emergent adverse events (TEAEs).

Time frame: Baseline up to Week 24

Data from ClinicalTrials.gov

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