Bermekimab for Hidradenitis Suppurativa

1
Effectiveness
2
Safety
K. Papp Clinical Research, Waterloo, Canada
Hidradenitis Suppurativa+1 More
Bermekimab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hidradenitis Suppurativa

Study Summary

This study is evaluating whether a new drug can help treat a skin condition called hidradenitis suppurativa.

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Eligible Conditions

  • Hidradenitis Suppurativa
  • Hidradenitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Bermekimab will improve 1 primary outcome and 23 secondary outcomes in patients with Hidradenitis Suppurativa. Measurement will happen over the course of Baseline to Week 16.

Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24h) Score at Week 16
Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score at Week 16
Change from Baseline in Itch Scale Score of HSSD- 24h at Week 16
Change from Baseline in Number of Draining Fistulas at Week 16
Change from Baseline in Number of Inflammatory Nodules at Week 16
Change from Baseline in Pain Scale Score of HSSD- 24h at Week 16
Change from Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
Change from Baseline in the Number of Abscesses at Week 16
Up to Week 36
Number of Participants with Antibodies to Bermekimab
Percentage of Participants with Abnormalities in Laboratory Parameters
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Serum Concentration of Bermekimab
Week 16
Percentage of Participants Achieving Complete Elimination of Abscesses at Week 16 Among those Participants with Abscesses at Baseline
Percentage of Participants Achieving Complete Elimination of Draining Fistulas at Week 16 Among those Participants with Draining Fistulas at Baseline
Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules at Week 16 Among those Participants with Inflammatory Nodules at Baseline
Percentage of Participants Achieving HiSCR75 at Week 16
Percentage of Participants Achieving HiSCR90 at Week 16
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2 at Week 16
Percentage of Participants Achieving at Least 50%, 75%, 90%, and 100% Reduction in Total AN Count at Week 16
Percentage of Participants with HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants with HS-IGA Score of Moderate (3) or Severe (4) at Baseline
Percentage of Participants with Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild (2) and with at least 2-grade Improvement Relative to Baseline at Week 16

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

5 Treatment Groups

Group 2: Adalimumab
Group 4: Bermekimab Dose 2
Placebo group

This trial requires 290 total participants across 5 different treatment groups

This trial involves 5 different treatments. Bermekimab is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Group 4: Bermekimab Dose 2Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every Week thereafter through Week 31.
Group 5: Bermekimab Dose 3Participants will receive bermekimab dose 3 SC and placebo SC at Week 0 and every week thereafter through Week 31.
Group 3: Bermekimab Dose 1Participants will receive bermekimab dose 1 SC and placebo SC at Week 0 followed by bermekimab dose 1 SC at week 1 and every week thereafter through Week 31.
Group 2: AdalimumabParticipants will receive adalimumab 40 milligrams (mg) SC at Week 0, placebo SC at Week 1 followed by adalimumab 40 mg SC and placebo SC at Week 2 and placebo SC at Week 3. Participants will then receive Adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.
Group 1: PlaceboParticipants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 3 SC every week thereafter through Week 31.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 36
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to week 36 for reporting.

Closest Location

K. Papp Clinical Research - Waterloo, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The investigator will determine if a participant has Hurley Stage II or III HS at the screening and baseline visits. show original
At least two different areas on the body must have HS lesions at both the screening and baseline visits in order for someone to be considered for the study show original
Do not receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention. show original
In order to participate in the study, you must have had hidradenitis suppurativa for at least one year prior to the baseline visit show original
The patient needs to have >= 5 abscesses and inflammatory nodules at the screening and baseline visit. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is bermekimab?

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Treatment with a humanized monoclonal antibody BmFab (a humanized monoclonal antibody bermekimab) for 4 weeks reduces the size of painful blisters in 94% of patients and improves other clinical measures in 95% of patients with hidradenitis suppurativa.

Unverified Answer

What is hidradenitis suppurativa?

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Hidradenitis suppurativa is an inflammatory skin disease with characteristic painful nodules and recurrent outbreaks of painful flare-ups and usually resolves spontaneously. We present an illustrated case showing how this rare disease can affect a patient's quality of life.

Unverified Answer

How many people get hidradenitis suppurativa a year in the United States?

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There are likely approximately 18 million people with HS in the US each year, representing 8 percent of the population. Most of those with HS are women. About three-quarters of women and one-third of men have HS. About one-fifth of people with HS will have more than one symptom.

Unverified Answer

Can hidradenitis suppurativa be cured?

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HS can be cured by excision after appropriate therapy for the initial inflammatory phase to prevent recurrence. Surgical removal is the cure of choice. A low recurrence rate of less than 10% after exclusion of remaining lesions can be expected.

Unverified Answer

What are the signs of hidradenitis suppurativa?

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Signs of hidradenitis suppurativa include: - Painless nodules in and around the hairline, scalp, underarms and genital area (-1), - Abnormalities of the hair follicle, abnormal hair growth (on hairline), painful lesions and abscesses (-2), - Erupting lesions, diffuse swelling in the groin and underarm (-3), and - Other signs and symptoms like - Abnormal appearance of the skin, - Abnormal skin color and pigmentation. - Increased skin hydration and - Decremented skin elasticity. - Tenderness and - Increased pain.

Unverified Answer

What causes hidradenitis suppurativa?

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Although hidradenitis suppurativa has been previously associated with HLA class-I and TIR super-typing, none of the tested HLA class-I or TIR genes were associated with HSS. Therefore, a hitherto unknown genetic factor may play a role in the development of hidradenitis suppurativa in some individuals. The current knowledge of the immunogenetic predisposition in hidradenitis suppurativa is limited and further studies of the immune system may be required to explain the pathology of HSS.

Unverified Answer

What are common treatments for hidradenitis suppurativa?

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Topical tretinoin is a commonly used treatment for skin HS. Surgical debridement of the lesions improves patients' well-being by decreasing pain; it should be considered after other options for skin HS fail. No single treatment is satisfactory for all patients, however.

Unverified Answer

Who should consider clinical trials for hidradenitis suppurativa?

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When a clinical trial is being considered, it should be based on three factors: The clinical severity and severity of symptoms, the duration before starting a trial, and the severity of the affected area on a patient's diagram of severity. However, the most useful factors to consider are the magnitude of the desired effect, the cost of the treatment in a short term, and the cost of the treatment over the entire trial. In the USA there are a number of clinical trials for the treatment of hidradenitis spp.

Unverified Answer

How does bermekimab work?

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Results from the Phase 2-3 trials support an anti-IL-17A-based mechanism of action for bermeqlimab in the treatment of HS. The safety profile of bermeqlimab is suggestive that it would be well tolerated in the treatment of HS, with a manageable, low-level infusion profile and no clinically significant immunogenicity. Overall, the investigational combination of interleukin-17A receptor antagonists and anti-TNFα agents with or without methotrexate in the treatment of patients with refractory moderate to severe refractory acne vulgaris appears to be well tolerated and can be considered as a next-generation treatment option for patients with moderate to severe refractory acne vulgaris.

Unverified Answer

Is bermekimab typically used in combination with any other treatments?

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Results from a recent clinical trial demonstrate that bermekimab is usually used in combination with other treatments, but the evidence given in the available literature is insufficient to allow for determining whether the combination is more effective than treatment with bermekimab alone.

Unverified Answer

Have there been any new discoveries for treating hidradenitis suppurativa?

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Recent research on treating HS have shown promising results, but most have come from non-clinical studies and clinical case reports rather than randomized controls or large clinical studies. Therefore, a treatment method for HS has not yet been thoroughly investigated to a level that would justify it being classified as a'standard therapy'. Clinicians continue to rely on empiric therapies.

Unverified Answer

What is the average age someone gets hidradenitis suppurativa?

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Hidradenitis suppurativa can occur in all people of different races and sexes, and it is commonly said to hit children before they reach puberty. However, there is currently not much evidence for this, especially for children and adolescents. The average age of onset for hidradenitis suppurativa is 16 and a half years, which means that the condition can be mistaken for acne, which has a similar symptom onset time. There is an ongoing debate regarding whether hidradenitis suppurativa is a genetic disease or an acquired disease. Hidradenitis suppurativa is not a rare disease in pediatric patients.

Unverified Answer
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