A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change

in Disease Symptoms

 

ID # NCT04430855

Recruitment Status: recruiting as of August 2020

Estimated completion date: March 20, 2022

Sponsors and Collaborators: AbbVie

Information provided by (Responsible Party): AbbVie

Brief Summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa (HS) in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.

Upadacitinib is an investigational drug being developed for the treatment of HS. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly (by chance) put into 1 of 2 groups, called treatment arms. They are randomized in a 2 to 1 ratio meaning more participants have a chance to receive upadacitinib compared to placebo. Adult participants with a diagnosis of hidradenitis suppurativa will be enrolled. Around 60 participants will be enrolled in the study in approximately 28 sites globally.

Participants will undergo approximately 35-days of screening followed by oral tablet upadacitinib or placebo once daily for 48 weeks and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks.

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend visits every other week, once a month, or once every 2 months during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Please link for complete details https://clinicaltrials.gov/ct2/show/NCT04430855

Locations: multiple locations please refer to link above for further information.

Contact: Abbvie Call Center 847-283-8955 abbviveclinicaltrials.com

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