A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable

Sponsor
Eli Lilly and Company
Study ID
NCT03428100
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.
  • Topical corticosteroid — DRUG
    Administered as standard-of-care.

Study Details

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.

Key Dates

Start date
May 15, 2018
Status verified
Apr 2024
Primary completion
Nov 25, 2019
Completion
Apr 20, 2023

Study Design

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

Arms

  • Experimental: 4 mg Baricitinib
    4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: 2 mg Baricitinib
    2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: 1 mg Baricitinib
    1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Placebo Comparator: Placebo
    Placebo administered orally once daily in combination with topical corticosteroids. Additional Placebo administered orally to maintain the blind.
  • Experimental: Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
    4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE Substudy 4 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)
    4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE Substudy 2 mg Baricitinib to 2 mg Baricitinib (Responders/Partial Responders)
    2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE Substudy 2 mg Baricitinib to 1 mg Baricitinib (Responders/Partial Responders)
    2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
    4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
    2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
    1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Placebo Comparator: LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
    Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
  • Experimental: LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
  • Experimental: LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
    Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

Primary Outcome Measure

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib) [ Time Frame: Week 16 ]

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