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 in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.

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

Alberta

Manitoba

More information about this study

clinicaltrials.gov