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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Upadacitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04430855

M20-040

Details and patient eligibility

About

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.

Full description

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.

Participants will undergo approximately 35-days of screening followed by a 48-week treatment period and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks. The treatment period will consist of a 12-week placebo-controlled, double-blind period (Period 1) and a 36-week blinded extension period (Period 2).

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Upadacitinib 30 mg

Experimental group

Description:

Participants will receive 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).

Treatment:

Drug: Upadacitinib

Placebo followed by Upadacitinib 15 mg

Experimental group

Description:

Participants will receive matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).

Treatment:

Drug: Placebo

Drug: Upadacitinib