Back to resultsA Study of Bermekimab in Patients With Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bermekimab Monoclonal Antibody 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa
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.
Sites / Locations
- Tennessee Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
400mg cohort, no prior treatment with anti-TNF agent(s)
400 mg cohort, prior treatment with anti-TNF agent(s)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Plasma Concentration of Bermekimab
An enzyme-linked immunosorbent assay (ELISA) was developed to specifically measure bermekimab levels in human plasma. The blood samples were collected at each pharmacokinetic (PK) collection time point for PK analysis.
Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease
Change from baseline in VAS score for disease was reported. The VAS is a validated, subjective measure for participants disease impression. Disease impression scores were recorded using a similar scale, with 0 representing "not at all severe" and 10 representing "extremely severe".
Change From Baseline to Week 12 in VAS Score for Pain
Change from baseline in VAS score for pain was reported. The VAS is a validated, subjective measure for acute and chronic pain. Pain scores were recorded by marking a number on a scale from 0 to 10, 0 representing "no pain" and 10 representing "extremely painful".
Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of disease symptoms and treatment on Quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL.
Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score
PGA is a physician's assessment of the severity of disease based on a 6-point scale (Clear [0], minimal [1], mild [2], moderate [3], severe [4], more severe [5]) ranging from 0-5. Higher score indicated more severity of disease.
Change From Baseline in Disease Activity Score (DAS) at Week 12
The DAS is the sum of scores of all affected areas of each participant. Each area was evaluated by the following formula: (the sum of the two largest diameters in each affected area in millimeter [mm]) * (Total number of lesions in the anatomic area multiplied by the degree of inflammation of each lesion on a scale of 0 to 3). A minimum score of 0 and there is no maximum score range. Higher scores indicate more disease activity.
Change From Baseline to Week 12 in Modified Sartorius Score (mSS)
mSS is used to quantify severity of HS. Points are awarded for 12 body areas (left-right axillae, left - right sub/inframammary areas, intermammary area, left - right buttocks, left-right inguinocrural folds, perianal area, perineal area and other): points were awarded for nodules (2 points each);abscesses (4points);fistulas (4points);scars (1point); other findings (1 point); and longest distance between two lesions (no active lesion or only 1 lesion equal to [=]0 points, less than [<]5cm=2points, 5-10cm=4points, greater than [>]10cm 6points) and if lesions are separated by normal skin (yes-0 points; no-6points). Total mSS is sum of the 12 regional scores. Change from baseline in mSS was not reported as the electronic data capture (EDC) system erroneously requested data for this endpoint to be input in centimeters versus millimeters and conversion was not possible because it was given in ranges. Therefore, there was not enough valid data to sufficiently perform this endpoint analysis.
Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
Change from baseline to Week 12 in inflammatory lesion (abscesses and inflammatory nodules) count was reported. The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)
The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consisted of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores were recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Full Information
NCT ID
NCT03512275
First Posted
April 11, 2018
Last Updated
February 16, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03512275
Brief Title
A Study of Bermekimab in Patients With Hidradenitis Suppurativa
Official Title
A Phase II, Open Label Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400mg cohort, no prior treatment with anti-TNF agent(s)
Arm Type
Experimental
Arm Description
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.
Arm Title
400 mg cohort, prior treatment with anti-TNF agent(s)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bermekimab Monoclonal Antibody 400 mg
Other Intervention Name(s)
MABp1
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Up to Visit 14 (up to Day 93)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description
Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Time Frame
Week 12
Title
Plasma Concentration of Bermekimab
Description
An enzyme-linked immunosorbent assay (ELISA) was developed to specifically measure bermekimab levels in human plasma. The blood samples were collected at each pharmacokinetic (PK) collection time point for PK analysis.
Time Frame
Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13)
Title
Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease
Description
Change from baseline in VAS score for disease was reported. The VAS is a validated, subjective measure for participants disease impression. Disease impression scores were recorded using a similar scale, with 0 representing "not at all severe" and 10 representing "extremely severe".
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in VAS Score for Pain
Description
Change from baseline in VAS score for pain was reported. The VAS is a validated, subjective measure for acute and chronic pain. Pain scores were recorded by marking a number on a scale from 0 to 10, 0 representing "no pain" and 10 representing "extremely painful".
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score
Description
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of disease symptoms and treatment on Quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score
Description
PGA is a physician's assessment of the severity of disease based on a 6-point scale (Clear [0], minimal [1], mild [2], moderate [3], severe [4], more severe [5]) ranging from 0-5. Higher score indicated more severity of disease.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Disease Activity Score (DAS) at Week 12
Description
The DAS is the sum of scores of all affected areas of each participant. Each area was evaluated by the following formula: (the sum of the two largest diameters in each affected area in millimeter [mm]) * (Total number of lesions in the anatomic area multiplied by the degree of inflammation of each lesion on a scale of 0 to 3). A minimum score of 0 and there is no maximum score range. Higher scores indicate more disease activity.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Modified Sartorius Score (mSS)
Description
mSS is used to quantify severity of HS. Points are awarded for 12 body areas (left-right axillae, left - right sub/inframammary areas, intermammary area, left - right buttocks, left-right inguinocrural folds, perianal area, perineal area and other): points were awarded for nodules (2 points each);abscesses (4points);fistulas (4points);scars (1point); other findings (1 point); and longest distance between two lesions (no active lesion or only 1 lesion equal to [=]0 points, less than [<]5cm=2points, 5-10cm=4points, greater than [>]10cm 6points) and if lesions are separated by normal skin (yes-0 points; no-6points). Total mSS is sum of the 12 regional scores. Change from baseline in mSS was not reported as the electronic data capture (EDC) system erroneously requested data for this endpoint to be input in centimeters versus millimeters and conversion was not possible because it was given in ranges. Therefore, there was not enough valid data to sufficiently perform this endpoint analysis.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
Description
Change from baseline to Week 12 in inflammatory lesion (abscesses and inflammatory nodules) count was reported. The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)
Description
The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consisted of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores were recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
Starting from time of study completion and for the next year
IPD Sharing Access Criteria
The Clinical Study Report (CSR) will be distributed to clinical sites who participated in the study.
Citations:
PubMed Identifier
32004568
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Bermekimab in Patients With Hidradenitis Suppurativa
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