An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)

Hidradenitis suppurativa (HS) is an inflammatory skin disease characterised by
recurrent, painful abscesses and fistulous tracts. Patients with HS objectively
have one of the lowest quality of life measures of any dermatologic disease.
Lesions characteristically occur in the axillary, groin, infra mammary, and/or
anogenital regions of the body. HS lesions may progress to form sinus tracts
and expansive abscesses. Sequelae include significant pain, scarring, and
psychological distress. The average age of onset is during the early 20s. The
global prevalence of HS is reported between 0.0003% and 4.1%. Underdiagnosis or
improper diagnosis is common. Overall, HS prevalence varies significantly based
on study
methodology; however, the disease appears to be more common than was previously
considered.
Treatment often begins with topical or oral antibiotics. When topical
medications and oral antibiotics fail, or the disease has progressed, biologics
are recommended. Adalimumab is the only approved biologic, with the response
rate of 42%-59% versus placebo response of 26% - 28%, with a schedule of weekly
subcutaneous (s.c.) dosing.
When the medical management is ineffective, surgery is the option. Some of the
most burdensome HS symptoms from patient perspective are pain, drainage and
explosive openings, itch, skin tightness (scarring), odour, fatigue and
flu-like symptoms. Patients reported to be unsatisfied with the level of
control offered by currently available treatment options and unmet needs from
the patient perspective include the need for new medical treatments with
favourable efficacy and tolerability profiles. In qualitative evidence, the
most important treatment goals from the patient perspective were pain, drainage
(including explosive openings) and fatigue.

The primary objective of this trial is to assess the long-term safety of
spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and
are qualified for entry into this trial. The secondary objectives are to
evaluate efficacy at a lower dose than tested in PoCC trial.

Open label, single-arm, multi-regimen, 2-year extension study in adult patients
with HS who have completed their treatment in the 1368-0052
PoCC trial, with a total treatment duration of 2 years.
Approximately 45 patients will be randomized.

Spesolimab (BI 655130) or matching placebo at visit 1. Thereafter, patients are
only treated with spesolimab.

Patients from the placebo arm of the 1368-0052 trial will be given an initial
1200 mg i.v. loading dose of spesolimab, followed by 600 mg spesolimab s.c.
every two weeks. Patients from the active arm of the 1368-0052 trial will be
given a loading dose of placebo followed by 600 mg spesolimab s.c. every two
weeks.

Total duration of intervention: 104 weeks.

Burden/ possible risk:
- Patient may experience side effects or adverse events of the study drug
- Patient may experience discomfort due to the procedures and measurements
during the study
- Additional procedures and measurements will be performed (outside SoC), as
described in the protocol (v1.0 / 16 Dec 2020)
- Participating in the study will take extra time
- Patient will be asked to fill out questionnaires and complete diaries
- Patient needs to adhere to the study schedule

Possible benefit:
- Spesolimab may improve the symptoms associated with HS
- Participation in the study helps researchers gain a better understanding of
HS.