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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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
5 months until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 30, 2023

Last Update Submit

October 30, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of adverse events (AEs).

    up to Week 60

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

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

March 30, 2024

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

November 3, 2023

Record last verified: 2023-10