A Study of Bermekimab in Patients With Hidradenitis Suppurativa

NCT03512275 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-PT045
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  An adverse event is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study.

  Up to Visit 14 (up to Day 93)

Secondary Outcomes (10)

• Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

  Week 12

• Plasma Concentration of Bermekimab

  Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13)

• Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease

  Baseline and Week 12

• Change From Baseline to Week 12 in VAS Score for Pain

  Baseline and Week 12

• Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score

  Baseline and Week 12

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Bermekimab Monoclonal Antibody 400 mg

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

EXPERIMENTAL

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.

Drug: Bermekimab Monoclonal Antibody 400 mg

Interventions

Bermekimab Monoclonal Antibody 400 mg DRUG

subcutaneous injection

Also known as: MABp1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Related Publications (1)

• 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.

  PMID: 32004568 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Director Clinical Research Dermatology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 30, 2018
• Study Start: June 20, 2018
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: March 14, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting from time of study completion and for the next year
• Access Criteria: The Clinical Study Report (CSR) will be distributed to clinical sites who participated in the study.

Locations

US (1)