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

AbbVie15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

adalimumabDRUG

Subcutaneous Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (8)

Nagoya City University Hospital /ID# 151495

Nagoya, Aichi-ken, Japan

Kurume University Hospital /ID# 152579

Kurume-shi, Fukuoka, Japan

Takagi Dermatological Clinic /ID# 151906

Obihiro, Hokkaido, Japan

University of the Ryukyus Hosp /ID# 152268

Nakagami-gun, Okinawa, Japan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.