NCT04430855

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

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.

Interventional study

Status:
Completed
Conditions:
Hidradenitis Suppurativa (HS)
Enrollment:
68 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-040
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.

- Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline, presence of HS
lesions in at least 2 distinct anatomical areas, and draining fistula count of <=20 at
Baseline.

- History of inadequate response or an intolerance to adequate trial of oral antibiotics
for treatment of HS.

- Required to use a daily antiseptic wash on HS lesions.

Exclusion Criteria:

- History of active skin disease (other than HS) that could interfere with assessment of
HS, including skin infections requiring systemic treatment within 4 weeks of the
Baseline visit.

All the cities where the clinical studies are located

London - N6H 5L5
Markham - L3P 1X2

Alberta

Manitoba

More information about this study

clinicaltrials.gov