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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pruritus of Unknown Origin
• Intervention / Treatment: Biological: CM310

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM310; 600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks	Biological: CM310; 600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks
Placebo Comparator: Placebo; once every two weeks	Biological: CM310; 600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters	Incidence of treatment-emergent adverse events (TEAEs).	Baseline up to Week 24

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: CM310_IIS_CP02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No