NCT05671445

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

August 1, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

December 26, 2022

Last Update Submit

July 28, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events

    Incidence of treatment-emergent Adverse events related to CM326

    at week 52

Study Arms (1)

CM326

EXPERIMENTAL

CM326 injection, subcutaneous (SC)

Biological: CM326

Interventions

CM326BIOLOGICAL

CM326 injection

CM326

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Qian Jia

CONTACT

+862888610620qianjia@keymedbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 4, 2023

Study Start

February 9, 2023

Primary Completion

March 28, 2024

Study Completion

March 28, 2025

Last Updated

August 1, 2023

Record last verified: 2023-03

Locations

CN(1)