A Study of Bermekimab in Patients With Hidradenitis Suppurativa
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|ClinicalTrials.gov Identifier: NCT03512275|
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: Bermekimab Monoclonal Antibody 400 mg||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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
Other Name: MABp1
- Incidence of Dose Limiting Toxicity [Safety and Tolerability] [ Time Frame: 13 weeks ]Dose limiting toxicity
- 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.
- 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.
- 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).
- 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.
- Change in count of abscesses and inflammatory nodules [ Time Frame: 13 weeks ]Count of abscesses and inflammatory nodules from baseline to week 13.
- 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.
- 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.
- 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.
- 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.
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
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|
|Principal Investigator:||Alice Gottlieb, MD||Department of Dermatology, Icahn School of Medicine at Mount Sinai, NY, NY|