A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Suppurative Hidradenitis; Acne Inversa; Hidradenitis Suppurativa

Treatments: Drug: bermekimab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019041

77474462HDS2002 (Other Identifier)

CR108834

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 3 patient groups, including a placebo group

bermekimab ew

Experimental group

Description:

2 800 mg bermekimab loading dose subcutaneous injections, followed by weekly 400 mg bermekimab injections

Treatment:

Drug: bermekimab

bermekimab eow

Experimental group

Description:

2 800 mg loading dose subcutaneous injections, followed by alternating weekly 400 mg bermekimab injections with matching placebo injections

Treatment:

Drug: bermekimab

Drug: placebo

placebo ew

Placebo Comparator group

Description:

2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections

Treatment:

Drug: placebo