A Study of Bermekimab in Patients With Hidradenitis Suppurativa

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• Hidradenitis Suppurativa 277
• Hidradenitis 160

Keywords

• Hidradenitis Suppurativa

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 42 is close to the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• 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

• 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

Interventions

• DrugBermekimab Monoclonal Antibody 400 mg

  subcutaneous injection

  Also known as: MABp1

Primary outcomes

1. 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.

   Time frame: Up to Visit 14 (up to Day 93)

Secondary outcomes

1. 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).

   Time frame: Week 12

2. 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.

   Time frame: Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13)

3. 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".

   Time frame: Baseline and Week 12

4. 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".

   Time frame: Baseline and Week 12

5. 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.

   Time frame: Baseline and Week 12

6. 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.

   Time frame: Baseline and Week 12

7. 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.

   Time frame: Baseline and Week 12

8. 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.

   Time frame: Baseline and Week 12

9. 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.

   Time frame: Baseline and Week 12

10. 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.

    Time frame: Baseline and Week 12

Baseline characteristics

Publications

• 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. PubMed 32004568 ↗

Study documents

• Protocol and statistical analysis plan · Aug 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Csr