A Study of CM310 in Subjects With Moderate-to-Severe Atop... | NCT06116565

Studies
A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT06116565

Sponsor

Keymed Biosciences Co.Ltd

Status

Unknown status

Last Update Posted

Nov 3, 2023Actual

Enrollment

300Estimated

Phase

Phase 2

Conditions

Atopic Dermatitis

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

Oct 2023

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

Mar 30, 2024Estimated

Primary Completion Date

Mar 30, 2026Estimated

Completion Date

Mar 30, 2026Estimated

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Oct 30, 2023

First Posted Date

Nov 3, 2023Actual

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

Oct 30, 2023

Last Update Posted Date

Nov 3, 2023Actual

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, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

Detailed Description

The study consists of an screening period, treatment period, and safety follow-up period.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CM310	Experimental		Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	CM310, subcutaneous injection	CM310

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events (AEs)	Incidence of adverse events (AEs).	up to Week 60

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
Age ≥ 18 and ≤ 75 years old.
With Atopic Dermatitis.

Exclusion Criteria:

Not enough washing-out period for previous therapy.
Concurrent disease/status which may potentially affect the efficacy/safety judgement.
Major surgeries are planned during the study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided