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Trial record 1 of 8 for:    xbiotech [Lead] | Phase 2
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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
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.

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.

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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. Incidence of Dose Limiting Toxicity [Safety and Tolerability] [ Time Frame: 13 weeks ]
    Dose limiting toxicity


Secondary Outcome Measures :
  1. Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 13 weeks ]
    Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas when compared with baseline; measured from baseline to 13 weeks.

  2. Physician's Global Assessment (PGA) [ Time Frame: 13 weeks ]
    Measurement from baseline to week 13 defined as follows: a) Clear, when there are no abscesses, draining fistulas, inflammatory nodules, or non-inflammatory nodules; b) Minimal, when there are no abscesses, draining fistulas or inflammatory nodules, and there is presence of non-inflammatory nodules; c) Mild, when there are no abscesses or draining fistulas, there are 1-4 inflammatory nodules, or when there is one abscess or draining fistula and no inflammatory nodules; d) Moderate, when the total number of abscesses is 0, the total number of draining fistulas is 0, and the total number of inflammatory nodules is at least 5; or when there is presence of one abscess or draining fistula and at least one inflammatory nodule; or when there are 2-5 abscesses or draining fistulas and less than 10 inflammatory nodules; e) Severe, when there are 2-5 abscesses or draining fistulas and at least 10 inflammatory nodules; and f) very severe when there are more than 5 abscesses or draining fistulas.

  3. Disease Activity Score [ Time Frame: 13 weeks ]
    Sum of scores of all affected areas of each patient. Each area will be evaluated by the following formula: (multiplication of the two largest diameters in each affected area in mm) x (degree of inflammation of each lesion on a scale of 0 to 3).

  4. Modified Sartorius Score [ Time Frame: 13 weeks ]
    Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.

  5. Change in count of abscesses and inflammatory nodules [ Time Frame: 13 weeks ]
    Count of abscesses and inflammatory nodules from baseline to week 13.

  6. VAS for disease. [ Time Frame: 13 weeks ]
    Change in patient reported outcomes for overall disease severity from baseline to week 13, on a visual analog scale of 1-10, with 10 being the most severe.

  7. VAS for pain [ Time Frame: 13 weeks ]
    Change in patient reported pain level from baseline to week 13, on a visual analog scale of 1-10, with 10 being the most severe.

  8. DLQI (Dematology Life Quality Index) [ Time Frame: 13 weeks ]
    Sum of the scores of each question, resulting in a maximum of 30 (greatest impairment), and a minimum of 0.

  9. Change in Hospital Anxiety and Depression Scale [ Time Frame: 13 weeks ]
    Set of fourteen questions, to be rated by patient on a scale of 0 to 3, 7 each intended to measure the patient's levels of anxiety and 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
XBiotech, Inc.
Investigators
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Principal Investigator: Alice Gottlieb, MD Department of Dermatology, Icahn School of Medicine at Mount Sinai, NY, NY
  Study Documents (Full-Text)

Documents provided by XBiotech, Inc.:
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Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT03512275    
Other Study ID Numbers: 2018-PT045
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
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 XBiotech, Inc.:
Hidradenitis Suppurativa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs