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

NCT04019041 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10883477474462HDS2002
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Hidradenitis Suppurativa; Acne Inversa; Suppurative Hidradenitis

Outcome Measures

Primary Outcomes (1)

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

  HiSCR was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

  Week 12

Secondary Outcomes (15)

• Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16

  Baseline, Week 12, Week 16

• Change Form Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Weeks 12 and 16

  Baseline, Week 12, Week 16

• Change From Baseline in Number of Draining Fistulas at Weeks 12 and 16

  Baseline, Week 12, Week 16

• Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

  Week 16

• Change From Baseline in Modified Hidradenitis Suppurativa Score (mHSS) at Weeks 12 and 16

  Baseline, Week 12, Week 16

Study Arms (3)

bermekimab ew

EXPERIMENTAL

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

Drug: bermekimab

bermekimab eow

EXPERIMENTAL

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

Drug: bermekimab; Drug: placebo

placebo ew

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

bermekimab DRUG

bermekimab 2 mL (200 mg/mL) pre-filled syringe

bermekimab eow; bermekimab ew

placebo DRUG

placebo 2 mL pre-filled syringe

bermekimab eow; placebo ew

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (33)

Desert Sky

Gilbert, Arizona, 85295, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Wolverine Clinical Trials

Santa Ana, California, 92705, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

Florida Academic Dermatology Centers

Coral Gables, Florida, 33134, United States

Location

Doral Medical Research

Doral, Florida, 33166, United States

Location

Floridian Research Institute

Miami, Florida, 33145, United States

Location

Florida International Medical Research

Miami, Florida, 33155, United States

Location

P&S Research, LLC

Miami, Florida, 33175, United States

Location

Accel Clinical Research

Orlando, Florida, 32819, United States

Location

Physica Clinical Research

Sebastian, Florida, 32958, United States

Location

Avita Clinical Research

Tampa, Florida, 33613, United States

Location

Forcare Clinical Research, Inc.

Tampa, Florida, 33613, United States

Location

Integrated Clincal Research LLC

West Palm Beach, Florida, 33406, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Randall Dermatology & Cosmetic Surgery

West Lafayette, Indiana, 47906, United States

Location

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Clinical Trials of SWLA

Lake Charles, Louisiana, 70605, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Clinical Research Solutions, LLC

Milan, Tennessee, 38358, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23233, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

bermekimab

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to every week bermekimab injections, every other week bermekimab injections, or every week placebo injections.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: September 16, 2019
• Primary Completion: May 19, 2020
• Study Completion: November 17, 2020
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (33)