NCT06116565

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2025

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

October 30, 2023

Last Update Submit

August 19, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of adverse events (AEs).

    up to Week 60

Secondary Outcomes (15)

  • Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit

    up to Week 60

  • Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit

    up to Week 60

  • Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit

    up to Week 60

  • Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit

    up to Week 60

  • Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

    up to Week 60

  • +10 more secondary outcomes

Study Arms (1)

CM310

EXPERIMENTAL
Biological: CM310

Interventions

CM310BIOLOGICAL

CM310, subcutaneous injection

CM310

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

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

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

October 30, 2023

First Posted

November 3, 2023

Study Start

December 21, 2023

Primary Completion

November 26, 2025

Study Completion

November 26, 2025

Last Updated

August 20, 2026

Record last verified: 2026-08

Locations

CN(1)