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

Ichnos Sciences

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: Placebo; Biological: GBR 830

Study type: Interventional

Funder types: Industry

Identifiers

NCT02683928

GBR 830-201

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

GBR 830

Experimental group

Description:

Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart.

Treatment:

Biological: GBR 830

Placebo

Placebo Comparator group

Description:

Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart.

Treatment:

Biological: Placebo