A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa; Acne Inversa; Suppurative Hidradenitis
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: bermekimab; placebo
Intervention description: bermekimab 2 mL (200 mg/mL) pre-filled syringe; placebo 2 mL pre-filled syringe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to every week bermekimab injections, every other week bermekimab injections, or every week placebo injections.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study further evaluates the efficacy of bermekimab in treating moderate to severe
      hidradenitis suppurativa in adults. 1/3 of patients will receive weekly injections of
      bermekimab, 1/3 will receive alternating every other week injections of bermekimab or
      placebo, and 1/3 will receive weekly injections of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent provided by the participant

          -  Male or female, age greater than or equal to (>=) 18 years

          -  Naïve to OR failure of prior targeted biologic therapy for Hidradenitis Suppurativa
             (HS) (including anti-TNF, anti-IL-17, or JAK inhibitor therapy)

          -  Diagnosis of HS for at least 1 year prior to screening.

          -  HS affecting at least two distinct anatomic areas, one of which is Hurley II or III
             stage.

          -  A total body count of abscesses and inflammatory nodules (AN) of at least 3.

          -  Full understanding of the procedures of the study protocol and willingness to comply
             with them.

          -  In case of female participants of childbearing potential, willingness to use one
             method of contraception of high efficacy during the entire study period. This method
             can be hormonal contraceptives or one of the following: condoms, diaphragm, or an
             intrauterine device. Women of non-childbearing potential include those considered to
             have a medical history that indicates that pregnancy is not a reasonable risk,
             including post-menopausal women and those with a history of hysterectomy or surgically
             sterilized.

        Exclusion Criteria:

          -  Age below 18 years.

          -  History of treatment with bermekimab for any reason.

          -  Receipt of oral antibiotic treatment for HS within 28 days prior to baseline.

          -  Receipt of prescription topical therapies for the treatment of HS within 14 days prior
             to baseline, and/or systemic non-biologic therapies for HS (immunosuppressants,
             corticosteroids, retinoids, or hormonal therapies) within 28 days prior to screening.

          -  Participant has been treated with any investigational drug of chemical or biologic
             nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug
             prior to baseline.

          -  History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or
             murine monoclonal antibodies.

          -  Has received a live (attenuated) vaccine over the 28 days prior to screening.

          -  Participant received oral concomitant analgesics (including opioids) for HS-related
             pain within 14 days prior to baseline.

          -  If entering the study on concomitant oral analgesics (including opioids) for
             non-HS-related pain: (a) Participant on opioid analgesics within 14 days prior to
             baseline visit; (b) Participant not on a stable dose of non-opioid oral analgesics for
             at least 14 days prior to baseline visit (PRN is not considered a stable dose).

          -  Participant requires or is expected to require opioid analgesics for any reason
             (excluding tramadol).

          -  Participant has a draining fistula count of greater than 20 at baseline.

          -  Major surgery (requiring general anesthesia or respiratory assistance) within 28 days
             prior to Day 0 of start of study drug.

          -  Hepatic dysfunction defined as any value of transaminases, of γ-glutamyl
             transpeptidase (γGT) or of total bilirubin > 3x upper normal limit.

          -  Known or suspected history of immunosuppression, including history of invasive
             opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis,
             coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution.

          -  Stage C Child-Pugh liver cirrhosis.

          -  History of human immunodeficiency virus (HIV) or active infection with hepatitis B
             virus (HBV) or hepatitis C virus (HCV).

          -  Neutropenia defined as <1,000 neutrophils/mm3.

          -  Pregnancy or lactation.