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A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986933
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: nemolizumab (CIM331) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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)
Drug: nemolizumab (CIM331)
Other: Placebo



Primary Outcome Measures :
  1. Percent improvement from baseline in pruritus Visual Analogue Scale (VAS) [ Time Frame: baseline to week12 ]
    Percent improvement from baseline in pruritus VAS at week12


Secondary Outcome Measures :
  1. Improvement from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: baseline to week12 (Part A), up to week64 (Part B) ]
  2. Improvement from baseline in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: baseline to week12 (Part A), up to week64 (Part B) ]
  3. Improvement from baseline in static Investigator's Global Assessment (sIGA) [ Time Frame: baseline to week12 (Part A), up to week64 (Part B) ]
  4. Improvement from baseline in Body Surface Area (BSA) of AD involvement [ Time Frame: baseline to week12 (Part A), up to week64 (Part B) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986933


Locations
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United States, Alabama
Anniston, Alabama, United States, 36207
United States, California
San Diego, California, United States, 92122
United States, Florida
Miami, Florida, United States, 33142
United States, Georgia
Alpharetta, Georgia, United States, 30022
United States, Illinois
Arlington Heights, Illinois, United States, 60005
Chicago, Illinois, United States, 60612
United States, Indiana
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Louisville, Kentucky, United States, 40202
Louisville, Kentucky, United States, 40217
United States, Michigan
Bay City, Michigan, United States, 48706
United States, New York
New York, New York, United States, 10016
United States, North Carolina
Charlotte, North Carolina, United States, 28226
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Charleston, South Carolina, United States, 29407
Charleston, South Carolina, United States, 29425
United States, Texas
College Station, Texas, United States, 77845
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
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Study Director: Ryosuke Mihara Chugai Pharmaceutical
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT01986933    
Other Study ID Numbers: CIM003JG
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases