A Study of CM310 in Subjects With Chronic Pruritus

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Pruritus of Unknown Origin

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05452343

CM310_IIS_CP02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

CM310

Experimental group

Description:

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

Treatment:

Biological: CM310

Placebo

Placebo Comparator group

Description:

once every two weeks

Treatment:

Biological: CM310