Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects
with moderate to severe Hidradenitis Suppurativa.

The study is multicenter and will consist of three subject groups. Subjects will be
randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or
placebo twice daily for 12 weeks.

Following the 12 weeks double-blind treatment period, subjects on placebo will be
re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks.
Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg
twice daily) for additional 24 weeks.

Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for
assessment of safety and efficacy.

Primary efficacy analysis will be at 12 weeks.

Inclusion Criteria:

- At least 18 years of age

- Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for
at least 6 months prior to Screening

- HS lesions are present in at least 2 distinct anatomic areas

- Inadequate or loss of response to a systemic course of antibiotics of at least 90 days

- Must have at least 3 inflammatory nodules or abscesses at screening

- Use adequate birth control for subject and partners of child bearing potential

- Willing and able to give written Informed Consent

Exclusion Criteria:

- Pregnant or breast-feeding

- Any other skin disease that may interfere with the assessment of HS

- Rapidly progressive, expanding HS within 30 days prior to screening

- More than 20 draining fistulae at screening

- Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be
prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug
and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment

- Systemic antibiotics are generally excluded

- Topical antibiotics use within 14 days prior to Day 1 is excluded

- Have started a topical prescription medicine for HS within 14 days prior to screening

- With the exception of permissible antibiotic treatment regimen, have received a
systemic medicine for HS, including biologics and other systemic therapies

- Have received within 14 days prior to Day 1 visit or is expected to require oral or
transdermal opioid analgesics (except for tramadol) for any reason