Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
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|ClinicalTrials.gov Identifier: NCT02904902|
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : February 27, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: adalimumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 6, 2016|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||May 30, 2019|
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).
Other Name: Humira
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ]HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
- Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12 [ Time Frame: Week 12 ]The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.
- Percentage 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 Numeric Rating Scale (NRS) >=3 [ Time Frame: Week 0 (Baseline), Week 2 ]The participant's Global Assessment of Skin Pain NRS was used to assess the worst skin pain due to HS. Scores 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 From Baseline to Week 12 in Modified Sartorius Scale Score [ Time Frame: Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, 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). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); 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 score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904902
|Nagoya City University Hospital /ID# 151495|
|Nagoya-shi, Aichi, Japan, 467-8602|
|Kurume University Hospital /ID# 152579|
|Kurume-shi, Fukuoka, Japan, 830-0011|
|Takagi Dermatological Clinic /ID# 151906|
|Obihiro, Hokkaido, Japan, 080-0013|
|University of the Ryukyus Hosp /ID# 152268|
|Nakagami-gun, Okinawa, Japan, 903-0215|
|NHO Osaka National Hosp /ID# 152452|
|Osaka-shi, Osaka, Japan, 540-0006|
|Tokai University Hachioji Hosp /ID# 151338|
|Hachioji, Tokyo, Japan, 〒192-0032|
|Tokyo Medical University Hospital /ID# 154171|
|Shinjuku-ku, Tokyo, Japan, 160-0023|
|Fukuoka University Hospital /ID# 151350|
|Fukuoka, Japan, 814-0180|
|Study Director:||AbbVie Inc.||AbbVie|