Back to resultsOpen-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring efficacy, safety, adalimumab, japanese participants
Eligibility Criteria
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.
Sites / Locations
- Nagoya City University Hospital /ID# 151495
- Kurume University Hospital /ID# 152579
- Takagi Dermatological Clinic /ID# 151906
- University of the Ryukyus Hosp /ID# 152268
- NHO Osaka National Hosp /ID# 152452
- Tokai University Hachioji Hosp /ID# 151338
- Tokyo Medical University Hospital /ID# 154171
- Fukuoka University Hospital /ID# 151350
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab
Arm Description
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).
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at 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
Percentage of Participants Achieving AN Count of 0, 1, or 2 at 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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02904902
Brief Title
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
efficacy, safety, adalimumab, japanese participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
Description
The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.
Time Frame
Week 12
Title
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
Description
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."
Time Frame
Week 0 (Baseline), Week 2
Title
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital /ID# 151495
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Kurume University Hospital /ID# 152579
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Takagi Dermatological Clinic /ID# 151906
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
University of the Ryukyus Hosp /ID# 152268
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
NHO Osaka National Hosp /ID# 152452
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Tokai University Hachioji Hosp /ID# 151338
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
〒192-0032
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 154171
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 151350
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_M15-573.pdf
Description
clinical study report synopsis
Learn more about this trial
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
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