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

Primary Purpose

Moderate-to-severe Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CM310
Placebo
Sponsored by
Keymed Biosciences Co.Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate-to-severe Atopic Dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Xiangya Hospital of Central South University
  • Wuxi Second Hospital
  • West China Hospital of Sichuan University
  • Hangzhou First People's Hospital
  • Peking University People's Hospital
  • Peking University Third Hospital
  • Shanghai Skin Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CM310 75mg arm

CM310 150mg arm

CM310 300mg arm

CM310 600(1st)+300mg(2nd,3rd) arm

placebo arm

Arm Description

75mg for 3 doses, every 2 weeks, SC

150mg for 3 doses, every 2 weeks, SC

300mg for 3 doses, every 2 weeks, SC

600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC

placebo for 3 doses, every 2 weeks, SC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pharmacokinetics parameter: Peak concentration (Cmax)
Peak concentration (Cmax)
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
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)
Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Pharmacokinetics parameter: Clearance rate (CL/F)
Clearance rate (CL/F)
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)
Pharmacodynamics parameters: Blood eosinophil count (EOS)
Blood eosinophil count (EOS)
Pharmacodynamics parameters: Total IgE level
Total IgE level
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
Proportion of Participants with anti-drug antibody (ADA)
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
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
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
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)
Preliminary efficacy: Proportion of subjects with EASI-75
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
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)

Full Information

First Posted
April 25, 2021
Last Updated
June 3, 2021
Sponsor
Keymed Biosciences Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04893941
Brief Title
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CM310 75mg arm
Arm Type
Experimental
Arm Description
75mg for 3 doses, every 2 weeks, SC
Arm Title
CM310 150mg arm
Arm Type
Experimental
Arm Description
150mg for 3 doses, every 2 weeks, SC
Arm Title
CM310 300mg arm
Arm Type
Experimental
Arm Description
300mg for 3 doses, every 2 weeks, SC
Arm Title
CM310 600(1st)+300mg(2nd,3rd) arm
Arm Type
Experimental
Arm Description
600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
placebo for 3 doses, every 2 weeks, SC
Intervention Type
Drug
Intervention Name(s)
CM310
Intervention Description
IL-4Rα monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
Description
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Pharmacokinetics parameter: Peak concentration (Cmax)
Description
Peak concentration (Cmax)
Time Frame
Baseline to Week 12
Title
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Description
Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Time Frame
Baseline to Week 12
Title
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Description
Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Time Frame
Baseline to Week 12
Title
Pharmacokinetics parameter: Clearance rate (CL/F)
Description
Clearance rate (CL/F)
Time Frame
Baseline to Week 12
Title
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
Description
Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)
Time Frame
Baseline to Week 12
Title
Pharmacodynamics parameters: Blood eosinophil count (EOS)
Description
Blood eosinophil count (EOS)
Time Frame
Baseline to Week 12
Title
Pharmacodynamics parameters: Total IgE level
Description
Total IgE level
Time Frame
Baseline to Week 12
Title
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
Description
Proportion of Participants with anti-drug antibody (ADA)
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with IGA 0 or 1
Description
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
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Description
Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Description
Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with EASI-50
Description
Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with EASI-75
Description
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Time Frame
Baseline to Week 12
Title
Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline
Description
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)
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. Other.
Facility Information:
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Wuxi Second Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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