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Clinical Trials/NCT04805411
NCT04805411
Completed
Phase 2

A Randomized, Double Blind, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Keymed Biosciences Co.Ltd25 sites in 1 country120 target enrollmentFebruary 24, 2021
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ConditionsModerate-to-severe Atopic Dermatitis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Moderate-to-severe Atopic Dermatitis
Sponsor
Keymed Biosciences Co.Ltd
Enrollment
120
Locations
25
Primary Endpoint
EASI-75
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Detailed Description

Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.

Registry
clinicaltrials.gov
Start Date
February 24, 2021
End Date
November 8, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Keymed Biosciences Co.Ltd
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
  • •Inadequate response to topical medications.

Exclusion Criteria

  • •Not enough washing-out period for previous therapy.
  • •Concurrent disease/status which may potentially affect the efficacy/safety judgement.
  • •Organ dysfunction.
  • •pregnancy.

Outcomes

Primary Outcomes

EASI-75

Time Frame: at Week 16

Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)

Secondary Outcomes

  • immunogenicity(Baseline to Week 24)
  • Investigator's Global Assessment (IGA) 0/1(at week 16)
  • The Eczema Area and Severity Index (EASI)-50(at week 16)
  • Pharmacokinetics parameters(Baseline to Week 24)
  • Improvement of Numerical Rating Scale (NRS)(at week 16)
  • Body Surface Area (BSA)(Baseline to Week 24)
  • Safety parameters(Baseline to Week 24)
  • reduction of IGA from baseline of ≥ 2 points(at week 16)
  • Pharmacodynamics(Baseline to Week 24)
  • The Eczema Area and Severity Index (EASI)-90(at week 16)
  • Dermatology Life Quality Index (DLQI)(Baseline to Week 24)

Study Sites (25)

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