A Study of CM310 in Subjects With Chronic Pruritus | NCT05452343

Studies
A Study of CM310 in Subjects With Chronic Pruritus

NCT05452343

Sponsor

Keymed Biosciences Co.Ltd

Status

Unknown status

Last Update Posted

Jul 11, 2022Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Chronic Pruritus of Unknown Origin

Interventions

CM310

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2022Estimated

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Mar 1, 2024Estimated

First Submitted Date

Jul 6, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CM310	Experimental	600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks	Biological: CM310
Placebo	Placebo Comparator	once every two weeks	Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks	CM310 Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided