Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: CM310

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Shanghai, China
    • Shanghai skin disease hospital
  • Hunan
    • Changsha, Hunan, China
      • Second Xiangya Hospital of Central South University
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi Second Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM310 75mg arm; 75mg for 3 doses, every 2 weeks, SC	Drug: CM310; IL-4Rα monoclonal antibody
Experimental: CM310 150mg arm; 150mg for 3 doses, every 2 weeks, SC	Drug: CM310; IL-4Rα monoclonal antibody
Experimental: CM310 300mg arm; 300mg for 3 doses, every 2 weeks, SC	Drug: CM310; IL-4Rα monoclonal antibody
Experimental: CM310 600(1st)+300mg(2nd,3rd) arm; 600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC	Drug: CM310; IL-4Rα monoclonal antibody
Placebo Comparator: placebo arm; placebo for 3 doses, every 2 weeks, SC	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)	Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: Peak concentration (Cmax)	Peak concentration (Cmax)	Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)	Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)	Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Baseline to Week 12
Pharmacokinetics parameter: Clearance rate (CL/F)	Clearance rate (CL/F)	Baseline to Week 12
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)	Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)	Baseline to Week 12
Pharmacodynamics parameters: Blood eosinophil count (EOS)	Blood eosinophil count (EOS)	Baseline to Week 12
Pharmacodynamics parameters: Total IgE level	Total IgE level	Baseline to Week 12
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)	Proportion of Participants with anti-drug antibody (ADA)	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1	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	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points	Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points	Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-50	Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-75	Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)	Baseline to Week 12
Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline	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)	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CM310AD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No