To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
NCT ID: NCT02683928
Last Updated: 2020-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2016-03-31
2017-06-30
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
QUADRUPLE
Study Groups
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GBR 830
Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart.
GBR 830
Placebo
Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart.
Placebo
Interventions
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GBR 830
Placebo
Eligibility Criteria
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Inclusion Criteria
* Atopic dermatitis involvement that of at least 10% body surface area
Exclusion Criteria
* Any cell-depleting agents including but not limited to rituximab: within 6 months prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before the baseline visit.
* Patient with history of serious local infection and systemic infection Patient with history or current evidence of diseases such as tuberculosis, malignant disease, other inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.
18 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals S.A.
INDUSTRY
Ichnos Sciences SA
INDUSTRY
Responsible Party
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Principal Investigators
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Gerhard Wolff, MD
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals
Locations
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Glenmark Investigational Site 14
Rogers, Arkansas, United States
Glenmark Investigational Site 5
Los Angeles, California, United States
Glenmark Investigational Site 3
San Diego, California, United States
Glenmark Investigational Site 15
Tampa, Florida, United States
Glenmark Investigational Site 11
St Louis, Missouri, United States
Glenmark Investigational Site 16
Berlin, New Jersey, United States
Glenmark Investigational Site 1
New York, New York, United States
Glenmark Investigational Site 9
Raleigh, North Carolina, United States
Glenmark Investigational Site 13
Fairborn, Ohio, United States
Glenmark Investigational Site 2
Dallas, Texas, United States
Glenmark Investigational Site 17
Katy, Texas, United States
Glenmark Investigational Site 12
Webster, Texas, United States
Glenmark Investigational Site 8
Markham, Ontario, Canada
Glenmark Investigational Site 7
Peterborough, Ontario, Canada
Glenmark Investigational Site 6
Richmond Hill, Ontario, Canada
Glenmark Investigational Site 10
Waterloo, Ontario, Canada
Glenmark Investigational Site 4
Montreal, Quebec, Canada
Countries
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References
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Guttman-Yassky E, Pavel AB, Zhou L, Estrada YD, Zhang N, Xu H, Peng X, Wen HC, Govas P, Gudi G, Ca V, Fang H, Salhi Y, Back J, Reddy V, Bissonnette R, Maari C, Grossman F, Wolff G. GBR 830, an anti-OX40, improves skin gene signatures and clinical scores in patients with atopic dermatitis. J Allergy Clin Immunol. 2019 Aug;144(2):482-493.e7. doi: 10.1016/j.jaci.2018.11.053. Epub 2019 Feb 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GBR 830-201
Identifier Type: -
Identifier Source: org_study_id
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