A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
NCT ID: NCT01986933
Last Updated: 2022-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
264 participants
INTERVENTIONAL
2013-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group1
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
nemolizumab (CIM331)
Group2
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
nemolizumab (CIM331)
Group3
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
nemolizumab (CIM331)
Group4
Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
nemolizumab (CIM331)
Group5
Part A: Placebo Part B: nemolizumab (CIM331)
nemolizumab (CIM331)
Placebo
Interventions
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nemolizumab (CIM331)
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Ryosuke Mihara
Role: STUDY_DIRECTOR
Chugai Pharmaceutical
Locations
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Anniston, Alabama, United States
San Diego, California, United States
Miami, Florida, United States
Alpharetta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Bay City, Michigan, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
College Station, Texas, United States
Norfolk, Virginia, United States
Countries
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References
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Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.
Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.
Other Identifiers
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CIM003JG
Identifier Type: -
Identifier Source: org_study_id
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