A Study of CM310 in Subjects With Chronic Pruritus

NCT ID: NCT05452343

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2024-03-01

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.

Conditions

Chronic Pruritus of Unknown Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CM310

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

Group Type: EXPERIMENTAL

CM310

Intervention Type: BIOLOGICAL

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

Placebo

once every two weeks

Group Type: PLACEBO_COMPARATOR

CM310

Intervention Type: BIOLOGICAL

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

Interventions

CM310

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CM310_IIS_CP02

Identifier Type: -

Identifier Source: org_study_id