Moderate-to-severe Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Interventions
DRUGCM310
IL-4Rα monoclonal antibody
DRUGPlacebo
Placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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 |
|---|---|---|
| Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing) | Baseline to Week 12 | Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) | Baseline to Week 12 | Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) |
| Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t) | Baseline to Week 12 | Area under the plasma concentration-time curve from 0 to t (AUC0-t) |
| Pharmacokinetics parameter: Clearance rate (CL/F) | Baseline to Week 12 | Clearance rate (CL/F) |
| Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC) | Baseline to Week 12 | Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS) |
| Pharmacodynamics parameters: Blood eosinophil count (EOS) | Baseline to Week 12 | Blood eosinophil count (EOS) |
| Pharmacodynamics parameters: Total IgE level | Baseline to Week 12 | Total IgE level |
| Pharmacokinetics parameter: Peak concentration (Cmax) | Baseline to Week 12 | Peak concentration (Cmax) |
| Preliminary efficacy: Proportion of subjects with IGA 0 or 1 | Baseline to Week 12 | Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1 |
| Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points | Baseline to Week 12 | Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points |
| Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points | Baseline to Week 12 | Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points |
| Preliminary efficacy: Proportion of subjects with EASI-50 | Baseline to Week 12 | Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline) |
| Preliminary efficacy: Proportion of subjects with EASI-75 | Baseline to Week 12 | Proportion of subjects with EASI-75 (≥75 percent improvement from baseline) |
| Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline | Baseline to Week 12 | Proportion of subjects with improvement (reduction) of pruritus Numerical Rating Scale(NRS) from baseline; The range of NRS is from 0 (no itch)-10 (worst imaginable itch) |
| Immunogenicity: Proportion of subjects with anti-drug antibody (ADA) | Baseline to Week 12 | Proportion of Participants with anti-drug antibody (ADA) |
Countries
China
Outcome results
None listed