This trial is evaluating whether LOU064 (blinded) will improve 2 primary outcomes and 10 secondary outcomes in patients with Chronic Spontaneous Urticaria. Measurement will happen over the course of 2 weeks.
This trial requires 450 total participants across 2 different treatment groups
This trial involves 2 different treatments. LOU064 (blinded) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"The symptom of chronic spontaneous urticaria may affect all ages of a patient's life. Therefore, treatment is important to prevent the symptom from becoming severe. This symptom is very difficult to treated and this justifies the need of new drugs." - Anonymous Online Contributor
"Because CSUs affect millions of U.S. adults, the cost of CSU to society is high. The American National Institutes of Health considers CSU to be one of the nation's most neglected and underserved conditions. These facts, along with the fact that CSU affects many young patients, cause us to encourage individuals with CSU to seek out information and treatments that can improve their quality of life." - Anonymous Online Contributor
"Most patients with chronic spondyloarthritis present with urticarial skin lesions. However, none of the patients with chronic spontaneous urticaria have skin lesions of a specific pattern typically seen in chronic spondyloarthritis. The diagnosis of chronic spontaneous urticaria is usually made as an incidental finding and many patients do not want to take any medication in view of the side effects. In certain situations treatment with antihistamine medications should be considered." - Anonymous Online Contributor
"As for many other medically unexplained conditions, treatments focus on alleviating the physical symptoms of the disease, and symptom management is paramount. As it is difficult to distinguish the underlying physiological mechanism, the best course of treatment still remains elusive." - Anonymous Online Contributor
"S. lichenoides can be an effective treatment for chronic spontaneous urticaria in women. The mechanism could be related to the antiestrogen effects of S. lichenoides or its antiinflammatory properties. S. lichenoides could be a treatment for chronic spontaneous urticaria." - Anonymous Online Contributor
"When diagnosing idiopathic CSU, it might be beneficial to include a question about the history of the disease. The use of a PDEI, cetirizine, might be beneficial, but further larger studies are needed." - Anonymous Online Contributor
"Although CSU has been classified as a more severe form of urticaria, our data suggest that CSU is associated with significant disease burden even in patients with early disease severity who are treated with appropriate medication." - Anonymous Online Contributor
"The present retrospective study shows that the patients in group A reported a statistically significant and consistent reduction in pruritus when compared with placebo in both the whole population of patients and patients with CSU, with an estimated response rate at week 18 of 52% and 43%, respectively. It is therefore plausible that in a prospective, blinded trial a larger percentage of patients could benefit from LOU064." - Anonymous Online Contributor
"We determined that there have been very few other trials evaluating the safety and efficacy of the lupus medication, lopatuzumab ((trade name) Lucentis). Most of these trials were examining the effect on arthritis. Other clinical trials have not been blinded or well-designed." - Anonymous Online Contributor
"A single outpatient visit of up to 30 minutes using lou064 in combination with other treatments has a significant effect on quality of life for those patients with chronic spontaneous urticaria. In a recent study, findings are consistent with evidence that lou064 increases QoL and reduces daily itch severity in patients with chronic itch." - Anonymous Online Contributor
"Subjects receiving lou064 had similar rates of adverse events to placebo. While it is likely that lou064 is safe when used as a treatment option for CSU, further studies to examine safety in a larger population is warranted." - Anonymous Online Contributor
"Most patients taking lou064 experienced [mild to moderate (2/6), moderate (6/6), or severe (16/18)] [increased/decreased (1/6), increased (5/6), decreased (2/6) symptoms]. Only 1/11 showed serious allergic reaction. Based on the data gathered from the clinical trials that lou064 passed, lou064 may be an effective treatment for CSU." - Anonymous Online Contributor