Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

Sponsor
AbbVie
Study ID
NCT02904902
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

Key Dates

Start date
Sep 6, 2016
Status verified
Apr 2020
Primary completion
Sep 1, 2017
Completion
May 30, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab
    Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4. After Week 52, Participants who consent to receive the 80 mg eow dose, will switch from 40 mg ew to 80 mg eow at Week 0x (80 mg eow period until the end of the study).

Primary Outcome Measure

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

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