Clinical trial NCT04019041: A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Acne Inversa
Suppurative Hidradenitis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to every week bermekimab injections, every other week bermekimab injections, or every week placebo injections.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change Form Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Number of Draining Fistulas at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Modified Hidradenitis Suppurativa Score (mHSS) at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Percentage of Participants Who Achieved HS-PGA of Clear (0) or Minimal (1) or HS-PGA Score of Mild or Better (<=2) With at Least a 2-grade Improvement Relative to Baseline at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Health Status as Assessed by EuroQol-5 Dimension Instrument-3 Levels (EQ-5D-3L) Visual Analogue Scale (VAS) Scores at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
timeFrame: Week 12, Week 16
measure: Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
timeFrame: Week 12, Week 16
measure: Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Change From Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD) Total Symptom Score at Weeks 12 and 16
timeFrame: Baseline, Week 12, Week 16
measure: Serum Concentration of Bermekimab
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 5, 8, 12, and 16
measure: Reduction From Baseline in Serum Interleukin-6 (IL-6)
timeFrame: Baseline, Weeks 8, 12 and 16
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Desert Sky
state: Arizona
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials
state: California
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Doral
country: United States
facility: Doral Medical Research
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: P&S Research, LLC
state: Florida
city: Orlando
country: United States
facility: Accel Clinical Research
state: Florida
city: Sebastian
country: United States
facility: Physica Clinical Research
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Clincal Research LLC
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: West Lafayette
country: United States
facility: Randall Dermatology & Cosmetic Surgery
state: Indiana
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA
state: Louisiana
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Milan
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Richmond
country: United States
facility: Dominion Medical Associates, Inc.
state: Virginia
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: