Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

Part of paid clinical trials in Beverly Hills, California.

Sponsor
AbbVie
Study ID
NCT02808975
Phase
PHASE4
Status
Completed

Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Subcutaneous injections administered as described in arm description
  • Adalimumab — DRUG
    Subcutaneous injections administered as described in arm description

Study Details

The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

Key Dates

Start date
Jul 18, 2016
Status verified
May 2020
Primary completion
May 16, 2019
Completion
Oct 16, 2019

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week
  • Active Comparator: Adalimumab
    Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: At Week 12 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Wallace Medical Group, Inc. /ID# 171289Beverly HillsCalifornia90211-
Encino Research Center / T. Jo /ID# 171347EncinoCalifornia91436-
University of California Irvine /ID# 170054IrvineCalifornia92697-1385-
Tulane Univ /ID# 168441New OrleansLouisiana70112-
Beth Israel Deaconess Medical Center /ID# 168438BostonMassachusetts02215-5400-
University of Michigan Hospitals /ID# 200667Ann ArborMichigan48109-
Univ NC Chapel Hill /ID# 168446Chapel HillNorth Carolina27514-4220-
Penn State Hershey Medical Ctr /ID# 168447HersheyPennsylvania17033-
Rhode Island Hospital /ID# 168439ProvidenceRhode Island02903-

Find similar trials in Beverly Hills, CA

By research site
Wallace Medical Group, Inc.· Beverly Hills, CAEncino Research Center / T. Jo· Encino, CAUniversity of California Irvine· Irvine, CATulane Univ· New Orleans, LABeth Israel Deaconess Medical Center· Boston, MAUniversity of Michigan Hospitals· Ann Arbor, MI

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