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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.