This trial is evaluating whether HZN-825 QD will improve 1 primary outcome and 8 secondary outcomes in patients with Sclerosis. Measurement will happen over the course of Baseline to Week 52.
This trial requires 300 total participants across 3 different treatment groups
This trial involves 3 different treatments. HZN-825 QD is the primary treatment being studied. Participants will be divided into 2 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.
Scleroderma not only prevents healing of broken or damaged tissues but also impairs tissue-repair mechanisms. Although no cure is known, early diagnosis and long-standing treatment have enabled many patients to maintain excellent health without disabling manifestations.
Sclerosis may be manifested through skin sores, decreased sensation, pain and loss of balance. It should be suspected if symptoms persist for more than 4 weeks in a person with an underlying systemic illness or history of joint pain.
According to the results of this study, 0.8% of men and 1.1% of women got sclerosis during their lifetime in the United States. When analyzing the data by ethnicity, 0.7% of white men, 1.0% of black men and 0.3% of white women had gotten sclerosis. In the Asian population, the number of people who got sclerosis was marginally higher, at 0.8%. The number of Hispanics was the lowest at 0.1%. These data, unfortunately, are incomplete because we have not included self-reported cases. For this reason, we cannot make assumptions about people's health histories from this estimate.
Sclerosis does not appear to be amenable to the same treatments used for most other diseases. Most therapies have been in a form of experimental use; however, new treatment technologies may present the future.
Cerebrovascular disease is a main cause of SSc. The mechanism is unknown but looks to be related to genetic factors and immune system activation. The presence of SSc increases the risk of cerebral thrombi. Other factors include high blood pressure and hyperglycaemia, which appear to be important in the pathogenesis of the disease. The aetiology is also unknown but it is thought to be multifactorial and is probably influenced by several genetic and environmental factors.
Given the importance of the immune system in the development of some diseases and the success of immunosuppressive therapy in their management, a good understanding of possible immune components in these diseases can explain why our patients have such diverse outcomes, including some failures of immunosuppression in these diseases, even when they present with similar diseases and the same treatments. Clinical trials should therefore be considered for all patients who present with new, unexplained symptoms of Scleroderma, Raynaud Syndrome, Pemphigus, and Discoid Lupus Erythematosus.
In the present study, we show noninvasively that the long-running administration of a single and low-volume iontophoresis of hzn-825 qd is sufficient to immunomodulate peripheral blood cells to the phenotype of myeloid-derived suppressive/pro-inflammatory monocytes within 2 weeks. This is consistent with data published for the same compound in vitro, suggesting that a single low-volume, low-potency iontophoresis could have therapeutic potential for the treatment of inflammatory conditions with high blood monocytes and/or MΦ.
There are no conclusive statistics relating to the severity of scleroderma, but scleroderma cases are often severe in nature. However, it is difficult to make some assumptions about the severity of scleroderma since the disorder is often difficult to diagnose and is poorly understood. It is even more difficult to determine the severity of scleroderma since there is not enough research on its effects on health. A way to determine if scleroderma is affecting your quality of life is if you are experiencing any of the manifestations that have not yet been listed above or if you are experiencing any of the symptoms of the disorder.
Oral Hzn-825, in doses up to 2 g/day, for 1 week is not associated with adverse effects in people with moderate-to-severe rheumatoid arthritis or the short- or intermediate-term toxicity in the Hzn-825 Phase II trials.
In a study aiming to identify the most effective combination of therapies for early and advanced breast cancer in combination with Zn-825 qd the combination of this drug, which was given for 6 months, with a steroid-based IM combination of a long-acting corticoid, tamoxifen, and an aromatase inhibitor resulted in significant antitumor activity.
Hzn-825 Qd could enhance the therapeutic effects of HA-ACS in SSc models; hence, the combination of HA-ACS and Hzn-825 Qd might create new therapeutic strategies for SSc.