Clinical trial NCT02904902: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: efficacy
safety
adalimumab
japanese participants
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 0 (Baseline), Week 2
measure: Change From Baseline to Week 12 in Modified Sartorius Scale Score
timeFrame: Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital /ID# 151495
state: Aichi
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 152579
state: Fukuoka
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic /ID# 151906
state: Hokkaido
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hosp /ID# 152268
state: Okinawa
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hosp /ID# 152452
state: Osaka
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hosp /ID# 151338
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 154171
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital /ID# 151350
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: