This trial is evaluating whether DMB-3115 will improve 1 primary outcome in patients with Psoriasis. Measurement will happen over the course of Week 8 (For EMA) and 12 (For FDA).
This trial requires 605 total participants across 2 different treatment groups
This trial involves 2 different treatments. DMB-3115 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
There is evidence of a role for immunological dysregulation in psoriasis. This may involve dysregulation of immune cells and their molecules or the impact of autoimmunity on epidermal biology.
Psoriasis is an autoimmune disorder of unknown cause and can be cured in many cases, without surgery or medication, by careful management of signs and symptoms. The exact mechanism is still unknown. Although some patients have responded or are in remission over many years, no study has succeeded in identifying the exact etiology of the disease, the pathogenetic pathways (the specific biochemical pathways that are triggered by autoantibodies). This contrasts with other, and more common, autoimmune diseases (including multiple sclerosis (MS) and diabetes mellitus which have become more manageable thanks to the discovery of their specific etiologies). Further research, however, remains warranted to fully understand the pathogenesis of psoriasis.
About 3.0 million people and about 1% of the American population are currently diagnosed with psoriasis at least once a year. In order to improve the health of millions of Americans, a better understanding of psoriasis is essential.
Pso is a chronic inflammatory skin disorder that is marked by scaly skin lesions of small, dome-shaped (macula), red and itchy plaques. Patients often also have a number of other systemic disease manifestations such as arthritis, and cardiovascular disease. It is found that there are about 1.7 million cases of Pso with varying severity and rates of mortality in different countries.
Signs of psoriasis are diverse and may include a variety of physical, psychologic and psychosocial symptoms. These are typically described as severe pain, skin lesions with thickness or scarring, itching and bleeding. These symptoms may also lead to a misdiagnosis of psoriasis of the skin and arthritis problems. Psoriasis is highly variable, sometimes appearing like a non-existent disease. The most common signs are the skin involvement with psoriasis such as pink patches and plaques. Many patients develop gut symptoms such as constipation, diarrhea and abdominal pain.
The cause of psoriasis remains unclear. Though many theories have been proposed, to date the theory most conclusively supported is a role for auto-antibodies directed against the epidermal membrane. Some of these auto-antibodies are also found against other human bodily surfaces, suggesting that the immune system may be attacking the body's own surfaces. The role of T-cells in causing psoriasis has also not yet been fully explored. Though many treatments are used to treat psoriasis, the cause is still not fully understood.
Common treatments for psoriasis may include ustekinumab, adalimumab, entecavir, tacrolimus, etanercept, and a combination of methotrexate and either ustekinumab or etanercept. There is limited evidence supporting immunosuppressive therapy as first-line therapy for psoriasis. Patients receiving systemic therapy tend to have a worse outcome. Anti-TNF agents may improve QoL and decrease fatigue and pain. However, these are not licensed medications in Australia or Western Europe.
A homeopathic treatment may not be beneficial for all patients, especially those with severe symptoms. The homeopathic treatment with dmb-3115 significantly reduced psoriasis severity in all patients. Although the patients on dmb-3115 reported higher overall improvement in QOL, there was no significant difference between the groups in the QOL scores and symptomology scores, after adjusting for the placebo effect.
Psoriasis is not curable. Treatment should be personalized according to the individual patient's response and his/her preferences. Therapeutic options will vary based on severity, body surface involvement and treatment approach. No single form of therapy is safe or effective in all cases.
There is no other clinical trials for psoriasis, so little is known about the development of dmb-3115 as a monotherapy and as an adjuvant. The small numbers in these studies preclude any firm conclusions. The authors recommend larger studies with longer duration, to assess dmb-3115 as a monotherapy or adjuvant therapy for the treatment of psoriasis. They believe that dmb-3115 has the potential to be a novel treatment for psoriasis. There is a need to assess and confirm its clinical efficacy, and in particular its safety.
The clinical and immunologic response to DMB-3115 in combination with other ASA treatments appear to be similar to that observed when DMB-3115 is given as a monotherapy.
In a randomized, placebo-controlled clinical trial, dmb-3115 was generally well tolerated. Only 12% of subjects reported experiencing headache (n = 4), headache worsened or worsened with increased dosage (n = 2), and 4% of subjects experienced abnormal liver liver function tests (n = 1). While the study does have several limitations, including a small sample size and a short duration of follow-up, the results do suggest that dmb-3115 may be appropriate for the long-term treatment of psoriasis. Further evaluation in a larger and more sustained study would be informative.