Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition that causes painful and inflamed lumps and abscesses often in the underarms, groin and buttocks. The purpose of this study is to assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with HS over 16 weeks, with or without previous treatment. The drug involved in this study, 0.3% topical roflumilast foam, is investigational.

Inclusion criteria

• Male or female subjects aged 12 years or older at time of consent (or assent).
• Participants and/or legal guardians are legally competent to sign and give informed consent or assent (for adolescents).
• Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 3 months.
• Diagnosis of HS (Hurley Stage I or II) with a total abscess and inflammatory nodule (AN) count of at least 4 to ≤10, with no draining tunnels at screening and baseline visits, affecting at least one distinct anatomical region.
• Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study.
• Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
• Subjects who have had surgery in the treatment area must be at least 3 months post-procedure (applies to deroofing/marsupialization or excision, not incision and drainage).
• Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline/Day 1 and agree to use at least one highly effective or barrier method of contraception throughout the study.

Females of non-childbearing potential must be premenarchal, postmenopausal (≥12 months spontaneous amenorrhea), or surgically sterile.

-In good health as judged by the Investigator based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) must be reliable and capable of adhering to the protocol and visit schedule.

Exclusion criteria

• Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
• Inability to discontinue prohibited medications or treatments before Baseline or during the study.
• Presence of draining tunnels at Screening or Baseline.
• Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during the study.
• Skin conditions other than HS that could interfere with evaluation of study medication.
• Conditions in the treatment area that could confound efficacy measurements.
• Known allergy to excipients in roflumilast foam.
• Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline.
• History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline.
• Pregnant, planning pregnancy during the study, or breastfeeding.
• Previous treatment with roflumilast cream or foam or current roflumilast use for another indication expected to continue during the study.
• Major surgery within 4 weeks before Baseline or planned during the study.
• History of chronic alcohol or drug abuse within 6 months before Screening.
• History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
• Parent(s)/legal guardian(s) or subjects unable to communicate, read, or understand the local language, or otherwise unsuitable for participation in the Investigator's opinion.
• Family members of the clinical study site, study staff, sponsor, or family members of enrolled subjects living in the same household.
• Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C).