A Study of Bermekimab in Patients With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Bermekimab Monoclonal Antibody 400 mg
Intervention description: subcutaneous injection
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa

Summary:

      Phase 2 study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent provided by the patient.

          -  Male or female, age 18 years or greater.

          -  For group A, patients must have received and failed anti-TNF therapy.

               -  For Group B, patients must not have received any prior treatment with any
                  anti-TNF therapy.

               -  Patients who have received 200 mg dose of bermekimab in this study (previous
                  version(s)) are eligible to begin receiving 400 mg dose starting with the
                  patient's next scheduled visit for the remainder of his/her treatment plan.

          -  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 patients of childbearing potential, willingness to use one method of
             contraception of high efficacy during the entire study period. This method can be
             intake of hormonal contraceptives or the use of 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.

        Exclusion Criteria:

          -  Age below 18 years.

          -  Receipt of oral antibiotic treatment for HS within 28 days prior to screening.

          -  Receipt of prescription topical therapies for the treatment of HS within 14 days prior
             to screening, and/or systemic therapies for HS (immunosuppressants, corticosteroids,
             retinoids, or hormonal therapies) within 28 days prior to screening.

          -  History of treatment with bermekimab for any reason, EXCEPT patients previously
             treated with 200 mg bermekimab dose in the previous version(s) of this study.

          -  History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or
             murine monoclonal antibodies.

          -  Has received a live (attenuated) vaccine over the 4 weeks prior to screening.

          -  New intake of opioid analgesics starting within 14 days prior to screening.

          -  Major surgery (requiring general anesthesia or respiratory assistance) within 28 days
             prior to Visit 1, Day 0 of start of study drug.

          -  Hepatic dysfunction defined as any value of transaminases or of γ-glutamyl
             transpeptidase (γGT), or of total bilirubin > 3 x upper normal limit

          -  Stage C Child-Pugh liver cirrhosis.

          -  Chronic infection by the human immunodeficiency virus (HIV), hepatitis B virus (HBV)
             and/or hepatitis C virus (HCV).

          -  Neutropenia defined as <1,000 neutrophils/mm3.

          -  Pregnancy or lactation.