Last updated 10 days ago
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
1328 patients around the world
Available in Puerto Rico, Spain, Chile, Brazil, United States
AbbVie
5Research sites
1328Patients around the world
This study is for people with
Hidradenitis suppurativa
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.Participant must have a total AN count of ≥ 5 at Baseline.HS lesions must be present in at least 2 distinct anatomic areas at Baseline.At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.Draining fistula count of ≤ 20 at Baseline.
- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
Sites
Hospital Moinhos de Vento
Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Recruiting
CDEC - Centro de Desenvolvimento em Estudos Clínicos Brasil
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Clínica Dermacross S.A. - Vitacura - Santiago
Recruiting
StudyStep-Up HS
SponsorAbbVie
Conditions
Hidradenitis suppurativa
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05889182
