Trial Outcomes & Findings for Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa (NCT NCT02904902)
NCT ID: NCT02904902
Last Updated: 2020-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
Week 12
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Adalimumab
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 6.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Modified Sartorius Scale
|
137.3 units on a scale
STANDARD_DEVIATION 59.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Adalimumab
n=15 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.
Outcome measures
| Measure |
Adalimumab
n=15 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
|
73.3 percentage of participants
Interval 44.9 to 92.2
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 2Population: 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.
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."
Outcome measures
| Measure |
Adalimumab
n=9 Participants
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.
|
|---|---|
|
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
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
SECONDARY outcome
Timeframe: Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12Population: 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.
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.
Outcome measures
| Measure |
Adalimumab
n=15 Participants
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.
|
|---|---|
|
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Week 2
|
-16.7 units on a scale
Standard Deviation 15.06
|
|
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Week 4
|
-38.7 units on a scale
Standard Deviation 31.46
|
|
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Week 8
|
-49.9 units on a scale
Standard Deviation 48.10
|
|
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Week 12
|
-61.4 units on a scale
Standard Deviation 45.05
|
Adverse Events
Adalimumab
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=15 participants at risk
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.
|
|---|---|
|
Infections and infestations
Cellulitis
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Subcutaneous abscess
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
Other adverse events
| Measure |
Adalimumab
n=15 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Eye disorders
Asthenopia
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Dental caries
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Gastric polyps
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Gastrointestinal disorders
Toothache
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
General disorders
Injection site induration
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
General disorders
Swelling
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
General disorders
Xerosis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Erythrasma
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Herpes simplex
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Influenza
|
40.0%
6/15 • Number of events 6 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
5/15 • Number of events 10 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Paronychia
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Periodontitis
|
26.7%
4/15 • Number of events 4 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Postoperative wound infection
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Pulpitis dental
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Subcutaneous abscess
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Tinea infection
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Investigations
Lymphocyte count increased
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Investigations
Weight increased
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 4 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
6.7%
1/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Surgical and medical procedures
Wisdom teeth removal
|
6.7%
1/15 • Number of events 1 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 2 • From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER