This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese
subjects with moderate to severe hidradenitis suppurativa (HS).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02904902
Ages eligible for Study
18 Years to 99 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT02904902
Nagoya City University Hospital
Nagoya-shi, Aichi, Japan, 467-8602
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan, 080-0013
University of the Ryukyus Hosp
Nakagami-gun, Okinawa, Japan, 903-0215
NHO Osaka National Hosp
Osaka-shi, Osaka, Japan, 540-0006
Tokai University Hachioji Hosp
Hachioji, Tokyo, Japan, 〒192-0032
Tokyo Medical University Hosp
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Trial results for NCT02904902
Participant Flow: Overall Study
14 / 15
Completed / Started
Serious Adverse Events
5 / 30
Affected / At Risk
Other Adverse Events
15 / 15
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT02904902. The sponsor of the trial is AbbVie and it is looking for 15 volunteers for the current phase.
Official trial 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
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