A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled,
Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab
(JNJ-77474462) for the Treatment of Subjects with Moderate to Severe Hidradenitis
Suppurativa.

Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology
that affects 1% to 4%
of the general population. HS typically manifests as recurrent, inflamed,
tender, SC nodules that are generally restricted to the
axillary, inguinal, and anogenital regions. While some nodules resolve
spontaneously, others progress to form sterile abscesses, which then rupture
into the skin, leading to the formation of fistulas and sinus tracts that can
spontaneously release purulent drainage. Over time, chronic inflammation
can lead to irreversible scarring and fibrosis, which in severe cases can
result in contractures and limitations in limb mobility, especially in the
axilla.

The purpose of this study is to compare the good and bad effects of bermekimab
to the good and bad effects of adalimumab and/or placebo. Adalimumab is a drug
already used to treat moderate to severe hidradenitis suppurativa (HS).

This is a Phase 2a/2b, multicenter interventional treatment study in
participants with moderate to severe HS. This study will be conducted in two
parts and will enroll a target of at least 290 participants. After
approximately 150 participants are enrolled in Part 1 of the study, enrollment
will be paused to evaluate the data. After this evaluation, enrollment will
resume, and approximately 140 participants will be enrolled into Part 2. All
participants will be dosed weekly (q1w). Three doses of active treatment will
be studied: Dose A, Dose B and Dose C.

Part 1: Part 1 will enroll approximately 150 participants. Participants will be
randomized to placebo (n = 50), active comparator (n = 50), or active treatment
*dose A* (n=50). At week 16 participants randomized to placebo will cross over
to receive active treatment *dose A* for 16 weeks. Participants with active
comparator will receive this treatment for 31 weeks. At week 16 participants
randomized to active treatment *dose A* will continue active treatment *dose A*
for an additional 16 weeks. All subjects will be followed for an additional 5
weeks of safety follow-up.

Part 2: Part 2 will be initiated after week 16 of Part 1 interim analysis is
completed. Approximately 140 patients will be enrolled in Part 2. Participants
will be randomized to receive placebo (n=20), active comparator (n=20), active
treatment *dose A* (n=20), active treatment *dose B* (n=40), or active
treatment *dose C* (n = 40). At week 16 participants randomized to placebo will
cross over to receive active treatment *dose A* for 16 weeks. Participants with
active comparator will receive this treatment for 31 weeks. At week 16,
participants randomized to active treatment *dose A*, *dose B* or *dose C* will
continue their respected dose regimens for an additional 16 weeks. All
participants will be followed for an additional 5 weeks of safety follow-up.

Potentially unknown discomfort, adverse events and risks are linked to the use
of the investigational product. It is possible that during the study
newinformation is brought to the attention of the sponsor regarding the
disease, investigationa product and the risks. If this is the case, the
investigator and his team will inform the patient in a timely manner. This new
information can potentially change the mind of the patient to continue his/her
trial participation.