This trial is evaluating whether LOU064 (open-label) will improve 2 primary outcomes and 11 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 (open-label) 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.
"around 3 million people in the United States will develop CU at some point during their lives. Some of these patients develop CU later in their life. Those with late onset CU are more likely to develop CU due to a lower urticarial disease activity at presentation." - Anonymous Online Contributor
"The prognosis of chronic spontaneous urticaria is variable, depending on the number of symptoms, disease duration and response to treatment. In cases with few symptoms and in cases with a prolonged spontaneous onset, the clinical course is somewhat better. The long term prognosis is still unpredictable." - Anonymous Online Contributor
"CSU patients are predominantly women, with a mean age of about 45 years, and more than 75% of them have symptoms of anxiety/depression. We also observed low prevalence of CSU related to the use of drugs, but with a slight increase during the symptomatic period." - Anonymous Online Contributor
"Spontaneous urticaria is a very common condition that is characterized by a variable onset and severity of symptoms. Most patients have at least a subset of the symptoms. Despite the recent introduction of several effective and generally well tolerated treatments, many are left with less than control of the symptoms. These patients' distress often exceeds that of those with other skin diseases like atopic dermatitis. Current and emerging treatments are discussed, as well as the current management guidelines." - Anonymous Online Contributor
"Chronic spontaneous urticaria usually has an autoimmune origin, due to some kind of immune system malfunction. It is a good strategy to manage the disease by giving drugs that suppress the immune response and diminish symptoms." - Anonymous Online Contributor
"The skin-prick test, serum histamine and tryptase levels are useful tools in the diagnosis of chronic spontaneous urticaria. The skin-prick test positivity might be linked to the production of histamine. There is also a trend for increased tryptase levels." - Anonymous Online Contributor
"The combination of lou064 plus low-dose topical anticholinergics appears to be safe and effective in patients with chronic urticaria, and it achieves improvements in patients as a stand-alone treatment or in combination with other medications." - Anonymous Online Contributor
"The safety and tolerability in both Phase 1 clinical trials has shown lou064 has a similar profile to other urushiols and it was generally well tolerated. Due to the potential toxicity from long-term treatment, clinicians and their partners now have a greater awareness of these new therapies (e.g. lou064) and to monitor patients for long term side effects. While the use of this medication requires the cooperation of their physician, a review of lou064's safety and efficacy profile can help determine if this is the therapeutic treatment for them. The clinical trial is a collaboration between the Faculty of Medicine at Monash University, Monash University and Monash University South Australia." - Anonymous Online Contributor
"Lou064 is well tolerated. The safety and efficacy profile of lou064 in LS are similar to those observed in a pivotal trial of 5-mino-adamantane administered 4.5 minutes after loratadine inhalation, which shows that lou064 could safely be administered in LS. ClinicalTrials.gov ID: NCT01558905." - Anonymous Online Contributor
"CSU is heritable, and the disease phenotype in siblings is correlated. CSU is caused by common, familial determinants as well as rare contributing variants, highlighting the importance of considering CSU as a genetic disorder that can, and should, be treated." - Anonymous Online Contributor
"The recent clinical trials with dapsone or azathioprine seem to be encouraging when compared to other treatments. Results from a recent paper suggest a need to study these drugs more closely in randomized-controlled trials, preferably including patients with mild or moderate-to-severe disease." - Anonymous Online Contributor
"In most patients, the predominant cause is idiopathic. However, it remains unclear why many individuals develop CSU when seemingly matched by history, autoantibodies, and autoantigen." - Anonymous Online Contributor