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

February 21, 2022 updated by: Keymed Biosciences Co.Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CM326 55 mg, once every two weeks (Q2W)
55mg for 6 doses, every 2 weeks, subcutaneous (SC)
Biological: CM326
CM326 injection
Experimental: CM326 110 mg, once every two weeks (Q2W)
110mg for 6 doses, every 2 weeks, subcutaneous (SC)
Biological: CM326
CM326 injection
Experimental: CM326 110 mg, once every four weeks (Q4W)
110mg for 3 doses, every 4 weeks, subcutaneous (SC)
Biological: CM326
CM326 injection
Experimental: CM326 220 mg, once every two weeks (Q2W)
220mg for 6 doses, every 2 weeks, subcutaneous (SC)
Biological: CM326
CM326 injection
Experimental: CM326 220 mg, once every four weeks (Q4W)
220mg for 3 doses, every 4 weeks, subcutaneous (SC)
Biological: CM326
CM326 injection
Placebo Comparator: Placebo
Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC)
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AE)
Time Frame: Up to week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Up to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Time Frame: Up to Week 24
Time to reach peak concentration (Tmax)
Up to Week 24
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Time Frame: Up to Week 24
Peak Plasma concentration (Cmax)
Up to Week 24
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
Time Frame: Up to Week 24
Area under the plasma concentration-time curve (AUC)
Up to Week 24
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Time Frame: Up to Week 24
Clearance rate (CL/F)
Up to Week 24
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
Time Frame: Up to Week 24
Elimination half life (T1/2z)
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in eosinophil count after CM326 administration
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
Time Frame: Up to Week 24
Changes from baseline in serum periostin concentration after CM326 administration
Up to Week 24
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time Frame: Up to Week 24
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Up to Week 24
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
Time Frame: Up to Week 24
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Up to Week 24
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
Time Frame: Up to Week 24
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit
Time Frame: Up to Week 24
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
Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit
Time Frame: Up to Week 24
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
Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit
Time Frame: Up to Week 24
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
Up to Week 24
Change from baseline in Eczema Area and Severity Index (EASI) score at each visit
Time Frame: Up to Week 24
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
Up to Week 24
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
Time Frame: Up to Week 24
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Up to Week 24
Percent change from baseline in Numerical Rating Scale (NRS)
Time Frame: Up to Week 24
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Up to Week 24
Body surface area (BSA) of involvement of atopic dermatitis
Time Frame: Up to Week 24
Change from baseline in percent of BSA
Up to Week 24
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
Time Frame: Up to Week 24
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
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Keymed Biosciences Co.Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM326AD001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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