Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
- Registration Number
- NCT04893941
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- Pregnancy.
- Other.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CM310 75mg arm CM310 75mg for 3 doses, every 2 weeks, SC CM310 150mg arm CM310 150mg for 3 doses, every 2 weeks, SC placebo arm Placebo placebo for 3 doses, every 2 weeks, SC CM310 300mg arm CM310 300mg for 3 doses, every 2 weeks, SC CM310 600(1st)+300mg(2nd,3rd) arm CM310 600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
Pharmacodynamics parameters: Total IgE level Baseline to Week 12 Total IgE level
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)
Preliminary efficacy: Proportion of subjects with EASI-75 Baseline to Week 12 Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Pharmacokinetics parameter: Peak concentration (Cmax) Baseline to Week 12 Peak concentration (Cmax)
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: Clearance rate (CL/F) Baseline to Week 12 Clearance rate (CL/F)
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA) Baseline to Week 12 Proportion of Participants with anti-drug antibody (ADA)
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 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)
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 EASI-50 Baseline to Week 12 Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)
Trial Locations
- Locations (7)
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Peking University Third Hospital
🇨🇳Beijing, China
Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Peking University People's Hospital
🇨🇳Beijing, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
Wuxi Second Hospital
🇨🇳Wuxi, Jiangsu, China