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The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

Primary Purpose

Moderate-to-severe Atopic Dermatitis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CM326
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:

  • With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
  • Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
  • Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
  • Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
  • The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
  • Provide signed informed consent

Exclusion Criteria:

  • Not enough washing-out period for previous therapy.
  • Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
  • Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
  • Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Sites / Locations

  • Peking University People's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CM326 55 mg, once every two weeks (Q2W)

CM326 110 mg, once every two weeks (Q2W)

CM326 110 mg, once every four weeks (Q4W)

CM326 220 mg, once every two weeks (Q2W)

CM326 220 mg, once every four weeks (Q4W)

Placebo

Arm Description

55mg for 6 doses, every 2 weeks, subcutaneous (SC)

110mg for 6 doses, every 2 weeks, subcutaneous (SC)

110mg for 3 doses, every 4 weeks, subcutaneous (SC)

220mg for 6 doses, every 2 weeks, subcutaneous (SC)

220mg for 3 doses, every 4 weeks, subcutaneous (SC)

Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC)

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AE)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Secondary Outcome Measures

Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Time to reach peak concentration (Tmax)
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Peak Plasma concentration (Cmax)
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Clearance rate (CL/F)
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
Elimination half life (T1/2z)
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
Changes from baseline in eosinophil count after CM326 administration
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
Changes from baseline in serum periostin concentration after CM326 administration
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Change from baseline in Eczema Area and Severity Index (EASI) score at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Percent change from baseline in Numerical Rating Scale (NRS)
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life

Full Information

First Posted
December 13, 2021
Last Updated
February 21, 2022
Sponsor
Keymed Biosciences Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05186922
Brief Title
The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis
Official Title
A Randomized, Double Blind, Placebo-Controlled, Multiple Dose Escalation, Phase 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

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
Data Monitoring Committee
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 CM326 in moderate-severe AD subjects.
Detailed Description
The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-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
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CM326 55 mg, once every two weeks (Q2W)
Arm Type
Experimental
Arm Description
55mg for 6 doses, every 2 weeks, subcutaneous (SC)
Arm Title
CM326 110 mg, once every two weeks (Q2W)
Arm Type
Experimental
Arm Description
110mg for 6 doses, every 2 weeks, subcutaneous (SC)
Arm Title
CM326 110 mg, once every four weeks (Q4W)
Arm Type
Experimental
Arm Description
110mg for 3 doses, every 4 weeks, subcutaneous (SC)
Arm Title
CM326 220 mg, once every two weeks (Q2W)
Arm Type
Experimental
Arm Description
220mg for 6 doses, every 2 weeks, subcutaneous (SC)
Arm Title
CM326 220 mg, once every four weeks (Q4W)
Arm Type
Experimental
Arm Description
220mg for 3 doses, every 4 weeks, subcutaneous (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC)
Intervention Type
Biological
Intervention Name(s)
CM326
Intervention Description
CM326 injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AE)
Description
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time Frame
Up to week 24
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Description
Time to reach peak concentration (Tmax)
Time Frame
Up to Week 24
Title
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Description
Peak Plasma concentration (Cmax)
Time Frame
Up to Week 24
Title
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
Up to Week 24
Title
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Description
Clearance rate (CL/F)
Time Frame
Up to Week 24
Title
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
Description
Elimination half life (T1/2z)
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Description
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
Description
Changes from baseline in eosinophil count after CM326 administration
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Description
Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Description
Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Description
Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Time Frame
Up to Week 24
Title
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
Description
Changes from baseline in serum periostin concentration after CM326 administration
Time Frame
Up to Week 24
Title
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Description
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time Frame
Up to Week 24
Title
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
Description
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Time Frame
Up to Week 24
Title
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
Description
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Time Frame
Up to Week 24
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to Week 24
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to Week 24
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to Week 24
Title
Change from baseline in Eczema Area and Severity Index (EASI) score at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to Week 24
Title
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
Description
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time Frame
Up to Week 24
Title
Percent change from baseline in Numerical Rating Scale (NRS)
Description
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time Frame
Up to Week 24
Title
Body surface area (BSA) of involvement of atopic dermatitis
Description
Change from baseline in percent of BSA
Time Frame
Up to Week 24
Title
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
Description
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life
Time Frame
Up to Week 24

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: With confirmed Atopic Dermatitis (AD) at least 12 months before the screening Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline Investigator's Global Assessment (IGA) score ≥3 at screening and baseline Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline The weekly mean score of daily peaks in pruritus NRS at baseline ≥4 Provide signed informed consent Exclusion Criteria: Not enough washing-out period for previous therapy. Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc. Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN). Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Jia
Phone
+862888610620
Email
qianjia@keymedbio.com
Facility Information:
Facility Name
Peking University People's hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang

12. IPD Sharing Statement

Learn more about this trial

The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

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