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A Study of Bermekimab in Patients With Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512275
Recruitment Status : Completed
First Posted : April 30, 2018
Results First Posted : March 14, 2022
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Bermekimab Monoclonal Antibody 400 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open Label Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 400mg cohort, no prior treatment with anti-TNF agent(s)
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
subcutaneous injection
Other Name: MABp1

Experimental: 400 mg cohort, prior treatment with anti-TNF agent(s)
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
subcutaneous injection
Other Name: MABp1




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to Visit 14 (up to Day 93) ]
    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 :
  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: 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).

  2. Plasma Concentration of Bermekimab [ Time Frame: Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13) ]
    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.

  3. Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease [ Time Frame: Baseline and Week 12 ]
    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".

  4. Change From Baseline to Week 12 in VAS Score for Pain [ Time Frame: Baseline and Week 12 ]
    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".

  5. Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline and Week 12 ]
    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.

  6. Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score [ Time Frame: Baseline and Week 12 ]
    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.

  7. Change From Baseline in Disease Activity Score (DAS) at Week 12 [ Time Frame: Baseline and 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.

  8. Change From Baseline to Week 12 in Modified Sartorius Score (mSS) [ Time Frame: Baseline and Week 12 ]
    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.

  9. Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count [ Time Frame: Baseline and Week 12 ]
    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.

  10. Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS) [ Time Frame: Baseline and Week 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512275


Locations
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United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03512275    
Other Study ID Numbers: 2018-PT045
First Posted: April 30, 2018    Key Record Dates
Results First Posted: March 14, 2022
Last Update Posted: March 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Clinical Study Report (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.

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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
Keywords provided by Janssen Research & Development, LLC:
Hidradenitis Suppurativa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs