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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05452343

Enrollment

Registered

2022-07-11

Start date

2022-08-30

Completion date

2024-03-01

Last updated

2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pruritus of Unknown Origin

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.

Interventions

BIOLOGICALCM310

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026