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Trial record 26 of 90 for:    hidradenitis suppurativa

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
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Intervention Drug: adalimumab
Enrollment 15
Recruitment Details  
Pre-assignment Details Interim results (through Week 24) are presented.
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Period Title: Overall Study
Started 15
Completed 14 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
completed 24 weeks of treatment and continued on study
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
42.1  (6.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
15
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Modified Sartorius Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
137.3  (59.21)
[1]
Measure Description: The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas. The total Sartorius Scale is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug.
1.Primary Outcome
Title Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Non responder imputation.
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.7
(59.5 to 98.3)
2.Secondary Outcome
Title Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
Hide Description The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Non responder imputation.
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.3
(44.9 to 92.2)
3.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Participants with Baseline NRS - at worst >=3.
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(7.5 to 70.1)
4.Secondary Outcome
Title Change From Baseline to Week 12 in Modified Sartorius Scale Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Last observation carried forward.
Arm/Group Title Adalimumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -16.7  (15.06)
Week 4 -38.7  (31.46)
Week 8 -51.5  (45.69)
Week 12 -61.4  (45.05)
Time Frame From first dose of study drug through Week 24.
Adverse Event Reporting Description Treatment-emergent adverse events are defined as any event with an onset or worsening date that is after the first dose of study drug and with an onset date no more than 70 days after the last dose of study drug.
 
Arm/Group Title Adalimumab
Hide Arm/Group 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.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   2/15 (13.33%) 
Infections and infestations   
Cellulitis  1  2/15 (13.33%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%)
Total   10/15 (66.67%) 
Blood and lymphatic system disorders   
Neutropenia  1  1/15 (6.67%) 
Eye disorders   
Asthenopia  1  1/15 (6.67%) 
Gastrointestinal disorders   
Dental caries  1  2/15 (13.33%) 
Diarrhoea  1  1/15 (6.67%) 
Toothache  1  2/15 (13.33%) 
General disorders   
Pyrexia  1  1/15 (6.67%) 
Infections and infestations   
Erythrasma  1  1/15 (6.67%) 
Folliculitis  1  1/15 (6.67%) 
Nasopharyngitis  1  3/15 (20.00%) 
Sinusitis  1  1/15 (6.67%) 
Skin infection  1  1/15 (6.67%) 
Injury, poisoning and procedural complications   
Post-traumatic neck syndrome  1  1/15 (6.67%) 
Investigations   
Lymphocyte count increased  1  1/15 (6.67%) 
Nervous system disorders   
Headache  1  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Erythema  1  1/15 (6.67%) 
Pruritis  1  1/15 (6.67%) 
Skin exfoliation  1  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02904902     History of Changes
Other Study ID Numbers: M15-573
First Submitted: September 14, 2016
First Posted: September 19, 2016
Results First Submitted: August 9, 2018
Results First Posted: February 27, 2019
Last Update Posted: June 18, 2019