A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
NCT ID: NCT04019041
Last Updated: 2023-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2019-09-16
2020-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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bermekimab ew
2 800 mg bermekimab loading dose subcutaneous injections, followed by weekly 400 mg bermekimab injections
bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
bermekimab eow
2 800 mg loading dose subcutaneous injections, followed by alternating weekly 400 mg bermekimab injections with matching placebo injections
bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
placebo
placebo 2 mL pre-filled syringe
placebo ew
2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections
placebo
placebo 2 mL pre-filled syringe
Interventions
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bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
placebo
placebo 2 mL pre-filled syringe
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Desert Sky
Gilbert, Arizona, United States
Marvel Clinical Research
Huntington Beach, California, United States
University of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
Visionary Investigators Network
Aventura, Florida, United States
Florida Academic Dermatology Centers
Coral Gables, Florida, United States
Doral Medical Research
Doral, Florida, United States
Floridian Research Institute
Miami, Florida, United States
Florida International Medical Research
Miami, Florida, United States
P&S Research, LLC
Miami, Florida, United States
Accel Clinical Research
Orlando, Florida, United States
Physica Clinical Research
Sebastian, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Forcare Clinical Research, Inc.
Tampa, Florida, United States
Integrated Clincal Research LLC
West Palm Beach, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Randall Dermatology & Cosmetic Surgery
West Lafayette, Indiana, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, United States
Clinical Trials of SWLA
Lake Charles, Louisiana, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
ClinOhio Research Services
Columbus, Ohio, United States
Clinical Research Solutions, LLC
Milan, Tennessee, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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77474462HDS2002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108834
Identifier Type: -
Identifier Source: org_study_id
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