Clinical trial NCT04893707: The Study of CM310 in Patients With Atopic Dermatitis
Official title: An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 2 Years
Secondary outcomes:
measure: Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)
timeFrame: Up to 2 Years
measure: 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
timeFrame: Up to 2 Years
measure: Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit
timeFrame: Up to 2 Years
measure: 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
timeFrame: Up to 2 Years
measure: 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
timeFrame: Up to 2 Years
measure: Change from baseline in EASI score at each visit
timeFrame: Up to 2 Years
measure: Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
timeFrame: Up to 2 Years
measure: Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
timeFrame: Up to 2 Years
measure: Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline
timeFrame: Up to 2 Years
measure: Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline
timeFrame: Up to 2 Years
measure: Percent change from baseline in NRS
timeFrame: Up to 2 Years
measure: Body Surface Area (BSA)
timeFrame: Up to 2 Years
measure: Time to first remission (achieving IGA = 0 or 1)
timeFrame: Up to 2 Years
measure: Time to first relapse (eg, IGA >2) after remission or to not achieving remission
timeFrame: Up to 2 Years
measure: Time to first EASI-50/75/90
timeFrame: Up to 2 Years
measure: Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment
timeFrame: Up to 2 Years
measure: Number of days on topical medication (per patient-year)
timeFrame: Up to 2 Years
measure: Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)
timeFrame: Up to 2 Years
measure: immunogenicity
timeFrame: Up to 2 Years
measure: Pharmacokinetics parameters
timeFrame: Up to 2 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
References: