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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa

Brief Summary: This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe Hidradenitis Suppurativa (HS).

Detailed Summary: Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in US and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.
Sponsor: AbbVie

Current Primary Outcome: Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: At Week 12 ]

HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to Baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of participants achieving AN count of 0, 1, or 2 at Week 12 [ Time Frame: At Week 12 ]
    The proportion of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with AN counts >=3 at Baseline
  • Proportion of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 2 among participants with Baseline NRS >=3 [ Time Frame: Week 0 (baseline) up to Week 12 ]
    The patient's Global Assessment of Skin Pain Numeric Rating Scale was used to assess the worst skin and average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours".
  • Change in modified Sartorius scale [ Time Frame: Week 0 (baseline) and Week 12 ]
    The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodule (2 points for each); abscesses (4 points); fistulas (4 points); scar (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points) The total Sartorius Scale is the sum of the 12 regional scores. Scale range will be 0 to infinite and larger scale represents higher severity of HS.


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: September 14, 2016
Date Started: September 2016
Date Completion: November 2019
Last Updated: April 13, 2017
Last Verified: April 2017