To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.

Key facts

Study ID

NCT02683928

Run by

Ichnos Sciences SA

People needed

64

Starts

2016-03-01

Expected to finish

2017-06-01

Last updated by the study team

2020-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years or older
• Atopic dermatitis involvement that of at least 10% body surface area

You may not qualify if…

• Treatment with systemic corticosteroids within 4 weeks before randomization, and topical steroids, tacrolimus and/or pimecrolimus within 1 week before the randomization (except emollients, and mild steroids (class 6 or 7)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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