The Study of CM326 in Adult Subjects With Atopic Dermatitis | NCT05671445

Studies
The Study of CM326 in Adult Subjects With Atopic Dermatitis

NCT05671445

Sponsor

Keymed Biosciences Co.Ltd

Status

Unknown status

Last Update Posted

Aug 1, 2023Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

CM326

Countries

China

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2023Actual

Primary Completion Date

Mar 28, 2024Estimated

Completion Date

Mar 28, 2025Estimated

First Submitted Date

Dec 26, 2022

First Submission Date that Met QC Criteria

Dec 31, 2022

First Posted Date

Jan 4, 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

Jul 28, 2023

Last Update Posted Date

Aug 1, 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 open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

Detailed Description

The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week 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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CM326	Experimental	CM326 injection, subcutaneous (SC)	Biological: CM326

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM326	Biological	CM326 injection	CM326

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent Adverse events related to CM326	at week 52

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

With confirmed Atopic Dermatitis (AD) at the screening.
Have the ability to understand the nature of the study and voluntarily sign the informed consent.
Be able to communicate well with investigators and follow up protocol requirements.
The subjects agreed to use highly effective contraceptive measures during the study.

Exclusion Criteria:

Not enough washing-out period for previous therapy.
Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
Major surgery is planned during the study period.
Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Jia	Contact	+862888610620		qianjia@keymedbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's hospital	Recruiting	Beijing			China

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