A Study of Bermekimab in Patients With Hidradenitis Suppurativa

NCT ID: NCT03512275

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2019-01-14

Brief Summary

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

Detailed Description

Phase 2, open label study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of two patient groups, each of which will receive a total of 13 X 400mg weekly subcutaneous injections of bermekimab: Group A (n=10) patients who have failed anti-TNF therapy, and Group B (n=10) patients who have had no prior treatment with biological agents that block TNF.

Patients will be followed for 13 weeks to allow for assessment of safety and preliminary efficacy.

Additionally, patients who had received the 200 mg weekly subcutaneous injections of bermekimab under the previous version of this protocol are eligible to begin receiving the 400 mg dose starting with his/her next scheduled visit, and for the remainder of his/her treatment plan.

XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

400mg cohort, no prior treatment with anti-TNF agent(s)

N=10 patients that have had no prior treatment with biological agents that block TNF will receive a total of 13 X 400mg subcutaneous injections of bermekimab. Dosing will occur weekly for 12 weeks, inclusive of visit 1 and visit 13.

Group Type: EXPERIMENTAL

Bermekimab Monoclonal Antibody 400 mg

Intervention Type: DRUG

subcutaneous injection

400 mg cohort, prior treatment with anti-TNF agent(s)

N=10 patients that have failed anti-TNF therapy will receive a total of 13 X 400mg subcutaneous injections of bermekimab. Dosing will occur weekly for 12 weeks, inclusive of visit 1 and visit 13.

Group Type: EXPERIMENTAL

Bermekimab Monoclonal Antibody 400 mg

Intervention Type: DRUG

subcutaneous injection

Interventions

Bermekimab Monoclonal Antibody 400 mg

subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

MABp1

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

References

Gottlieb A, Natsis NE, Kerdel F, Forman S, Gonzalez E, Jimenez G, Hernandez L, Kaffenberger J, Guido G, Lucas K, Montes D, Gold M, Babcock C, Simard J. A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain. J Invest Dermatol. 2020 Aug;140(8):1538-1545.e2. doi: 10.1016/j.jid.2019.10.024. Epub 2020 Jan 29.

Reference Type: DERIVED

PMID: 32004568 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-PT045

Identifier Type: -

Identifier Source: org_study_id