Hidradenitis Suppurativa
Conditions
Keywords
efficacy, safety, adalimumab, japanese participants
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.
Interventions
DRUGadalimumab
Subcutaneous Injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12 | 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 | 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 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 6.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Modified Sartorius Scale | 137.3 units on a scale STANDARD_DEVIATION 59.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 5 / 15 |
Outcome results
Primary
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.
Time frame: Week 12
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | 86.7 percentage of participants |
Secondary
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.
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline to Week 12 in Modified Sartorius Scale Score | Week 2 | -16.7 units on a scale | Standard Deviation 15.06 |
| Adalimumab | Change From Baseline to Week 12 in Modified Sartorius Scale Score | Week 4 | -38.7 units on a scale | Standard Deviation 31.46 |
| Adalimumab | Change From Baseline to Week 12 in Modified Sartorius Scale Score | Week 8 | -49.9 units on a scale | Standard Deviation 48.1 |
| Adalimumab | Change From Baseline to Week 12 in Modified Sartorius Scale Score | Week 12 | -61.4 units on a scale | Standard Deviation 45.05 |
Secondary
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.
Time frame: Week 12
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12 | 73.3 percentage of participants |
Secondary
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.
Time frame: Week 0 (Baseline), Week 2
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab | 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 |