NCT04893707

Brief Summary

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

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

May 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

May 15, 2021

Last Update Submit

November 6, 2024

Conditions

Moderate-to-severe Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Number of Treatment Emergent Adverse Events (TEAEs)

    The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs

    Up to 2 Years

Secondary Outcomes (20)

  • Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)

    Up to 2 Years

  • Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit

    Up to 2 Years

  • Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit

    Up to 2 Years

  • Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit

    Up to 2 Years

  • Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit

    Up to 2 Years

  • +15 more secondary outcomes

Study Arms (1)

CM310

EXPERIMENTAL

adults and teenagers (12 \~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 \~ 18 years) with weight ≥30 kg and \<60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Biological: CM310

Interventions

CM310BIOLOGICAL

adults and teenagers (12 \~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 \~ 18 years) with weight ≥30 kg and \<60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Also known as: IL-4Rα monoclonal antibody
CM310

Eligibility Criteria

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

You may qualify if:

  • Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
  • Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
  • Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
  • Provide signed informed consent

You may not qualify if:

  • Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab\*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310.
  • Not enough washing-out period for previous therapy.
  • Pregnancy.
  • Other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's hospital

Beijing, China

Location

Related Publications (1)

  • Zhao Y, Li JY, Yang B, Ding YF, Wu LM, Zhang LT, Wang JY, Lu QJ, Zhang CL, Zhang FR, Zhu XH, Li YM, Tao XH, Diao QC, Li LF, Lu JY, Man XY, Li FQ, Xia XJ, Song JR, Jia YM, Zhang LB, Chen B, Zhang JZ. Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial. BioDrugs. 2024 Sep;38(5):681-689. doi: 10.1007/s40259-024-00668-z. Epub 2024 Jul 31.

    PMID: 39080181DERIVED

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

May 15, 2021

First Posted

May 19, 2021

Study Start

June 7, 2021

Primary Completion

February 3, 2023

Study Completion

February 3, 2023

Last Updated

November 8, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)