The Study of CM310 in Patients With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2023-02-03

Brief Summary

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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).

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Detailed Description

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The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Conditions

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Moderate-to-severe Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM310

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.

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

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.

Interventions

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CM310

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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IL-4Rα monoclonal antibody

Eligibility Criteria

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Inclusion Criteria

1. Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:

1. Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
2. 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 .
2. Provide signed informed consent

Exclusion Criteria

1. 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.
2. Not enough washing-out period for previous therapy.
3. Pregnancy.
4. Other

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No