Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01468233
Phase
PHASE3
Status
Completed

Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Adalimumab pre-filled syringe, administered by subcutaneous injection
  • placebo — BIOLOGICAL
    Placebo pre-filled syringe, administered by subcutaneous injection

Study Details

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

Key Dates

Start date
Nov 30, 2011
Status verified
Jul 2021
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo for 12 weeks.
  • Experimental: Adalimumab Every Week (EW)
    Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
  • Placebo Comparator: Placebo/Placebo
    Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
  • Experimental: Adalimumab Every Week (EW)/Placebo
    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
  • Experimental: Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)
    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
  • Experimental: Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ]

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