A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

January 18, 2022 updated by: Chugai Pharmaceutical

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Study Overview

Status

Status

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

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.

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 (Actual)

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.
264

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

Contacts and Locations

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

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
    • California
      • San Diego, California, United States, 92122
    • Florida
      • Miami, Florida, United States, 33142
    • Georgia
      • Alpharetta, Georgia, United States, 30022
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46256
    • Kentucky
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40217
    • Michigan
      • Bay City, Michigan, United States, 48706
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Oregon
      • Portland, Oregon, United States, 97239
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 29407
    • Texas
      • College Station, Texas, United States, 77845
    • Virginia
      • Norfolk, Virginia, United States, 23507

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 and ≤65 years of age at the time of consent.
  • Patients with Atopic Dermatitis
  • Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
  • Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
  • static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion Criteria:

  • Serological evidence of hepatitis B virus or hepatitis C virus infection
  • Known human immunodeficiency virus infection
  • Ongoing treatment with specific or non-specific hyposensitization therapy for AD
  • Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
  • History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
  • Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
  • Pregnant or lactating women.

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: PARALLEL
  • Masking: DOUBLE

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: Group1
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Drug: nemolizumab (CIM331)
EXPERIMENTAL: Group2
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Drug: nemolizumab (CIM331)
EXPERIMENTAL: Group3
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Drug: nemolizumab (CIM331)
EXPERIMENTAL: Group4
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
Drug: nemolizumab (CIM331)
EXPERIMENTAL: Group5
Part A: Placebo Part B: nemolizumab (CIM331)
Other: Placebo
Drug: nemolizumab (CIM331)

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
Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
Time Frame: baseline to Week 12

Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).

When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12

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
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
Time Frame: baseline to Week 12 (Part A)

EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).

When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A)
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Time Frame: baseline to Week 12 (Part A), up to Week 64 (Part B)

EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).

When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
Time Frame: baseline to Week 12 (Part A)

SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]).

When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A)
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Time Frame: baseline to Week 12 (Part A), up to Week 64 (Part B)

SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]).

When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
Time Frame: baseline to Week 12 (Part A)

The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.

When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A)
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Time Frame: baseline to Week 12 (Part A), up to Week 64 (Part B)

The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.

When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
baseline to Week 12 (Part A), up to Week 64 (Part B)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
Time Frame: baseline to Week 12 (Part A)

The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.

When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
baseline to Week 12 (Part A)
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Time Frame: baseline to Week 12 (Part A), up to Week 64 (Part B)

The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.

When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
baseline to Week 12 (Part A), up to Week 64 (Part B)

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.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ryosuke Mihara, Chugai Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
November 1, 2013

Primary Completion (ACTUAL)

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.
April 1, 2015

Study Completion (ACTUAL)

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.
June 1, 2016

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).
October 31, 2013

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.
November 12, 2013

First Posted (ESTIMATE)

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.
November 19, 2013

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.
January 25, 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.
January 18, 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.
January 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.
  • CIM003JG

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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