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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02904902
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : February 27, 2019
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: adalimumab Phase 3

Detailed Description:
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 United States (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
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).
Drug: adalimumab
Subcutaneous Injection
Other Name: Humira

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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."

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant must have a diagnosis of HS;
  • Participant must have any HS symptom at least 6 months prior to Baseline;
  • HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
  • Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
  • Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.

Exclusion Criteria:

  • Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
  • Any other active skin lesion or condition that may interfere with assessment of HS;
  • Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
  • Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
  • Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
  • Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02904902

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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
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] July 7, 2016
Statistical Analysis Plan  [PDF] November 7, 2017

Additional Information:
AbbVie  This link exits the site

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Responsible Party: AbbVie Identifier: NCT02904902    
Other Study ID Numbers: M15-573
First Posted: September 19, 2016    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
japanese participants
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Anti-Inflammatory Agents
Antirheumatic Agents