Secukinumab for Treatment of Atopic Dermatitis

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT02594098
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
  • Placebo — DRUG
    At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.

Study Details

Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families. In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.

Key Dates

Start date
Nov 30, 2015
Status verified
May 2019
Primary completion
Jan 30, 2018
Completion
Jan 30, 2018

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
  • Placebo Comparator: Placebo
    Placebo via subcutaneous injection using 2 prefilled syringes

Primary Outcome Measure

Fold-Change in Epidermal Thickness of Lesional Skin [ Time Frame: at Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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