A Study of CM310 in Subjects With Chronic Pruritus

Sponsor

Keymed Biosciences Co.Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05452343

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pruritus of Unknown Origin	Biological: CM310	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Safety parameters [Baseline up to Week 24]
Incidence of treatment-emergent adverse events (TEAEs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Keymed Biosciences Co.Ltd

ClinicalTrials.gov Identifier:

NCT05452343

Other Study ID Numbers:

CM310_IIS_CP02

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pruritus

Study Results

No Results Posted as of Jul 11, 2022