Moderate-to-severe Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis
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.
Interventions
BIOLOGICALCM310
IL-4Rα monoclonal antibody
BIOLOGICALPlacebo
Placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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. * Other.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI-75 | at Week 16 | Proportion of subjects with EASI-75 (≥75 percent improvement from baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of IGA from baseline of ≥ 2 points | at week 16 | Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points. |
| The Eczema Area and Severity Index (EASI)-90 | at week 16 | Proportion of subjects with EASI-90 (≥90 percent improvement from baseline) |
| The Eczema Area and Severity Index (EASI)-50 | at week 16 | Proportion of subjects with EASI-50 (≥50 percent improvement from baseline) |
| Improvement of Numerical Rating Scale (NRS) | at week 16 | Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch). |
| Body Surface Area (BSA) | Baseline to Week 24 | Change from baseline in percent of BSA |
| Investigator's Global Assessment (IGA) 0/1 | at week 16 | Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points. |
| Safety parameters | Baseline to Week 24 | Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
| Pharmacokinetics parameters | Baseline to Week 24 | trough concentration and exposure of CM310 |
| Pharmacodynamics | Baseline to Week 24 | Serum Thymus and activation regulated chemokine (TARC) |
| immunogenicity | Baseline to Week 24 | Detection of anti-drug antibody (ADA) |
| Dermatology Life Quality Index (DLQI) | Baseline to Week 24 | Change from baseline in DLQI |
Countries
China
Outcome results
None listed