A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- AbbVie
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.
Details
| Condition | Hidradenitis Suppurativa |
|---|---|
| Age | 18-100 years |
| Treatment | Upadacitinib, Placebo Upadacitinib |
| Clinical Study Identifier | NCT04430855 |
| Sponsor | AbbVie |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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