This trial is evaluating whether BMS-986165 will improve 1 primary outcome and 17 secondary outcomes in patients with Lupus Erythematosus, Discoid. Measurement will happen over the course of Week 16.
This trial requires 75 total participants across 5 different treatment groups
This trial involves 5 different treatments. BMS-986165 is the primary treatment being studied. Participants will be divided into 4 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.
"Lupus erythematosus, cutaneous is a chronic skin disorder characterized by a systemic disease. It has variable clinical course and is seen in all races and ethnicities, predominantly in the elderly, but it is not entirely uncommon in younger patients." - Anonymous Online Contributor
"It is not possible to definitively recommend what therapy to use for cutaneous lupus; however, the current literature suggests that topical corticosteroids are efficacious in the treatment of chronic cutaneous lupus.\n" - Anonymous Online Contributor
"Chronic photosensitivity and a history of recurrent cellulitis, but not discoid lupus erythematosus, lupus erythematosus, cutaneous, or lupus erythematosus, other are reliable signs of LE, cutaneous. The presence of any of these manifestations in an otherwise healthy individual is most associated with the presence of underlying LE. The use of phototesting should be considered in the evaluation of any patient with photosensitivity, and especially those with a history of recurrent cellulitis." - Anonymous Online Contributor
"Although the causes of most conditions are not fully understood, current evidence highlights the association of infections with cutaneous lupus erythematosus. These types of infections appear to be associated more commonly with flares of cutaneous lupus erythematosus than with flares without them. As infections with Candida species occur more commonly in individuals with SLE than unaffected individuals, consideration should be given to the possible impact of infection in the induction of cutaneous lupus erythematosus." - Anonymous Online Contributor
"Even though one of the goals of therapy of chronic cutaneous lupus is to prevent the development and progression of cutaneous involvement, the role of anti-TNFalpha therapy in chronic cutaneous lupus has yet to be fully investigated. It is important to keep in mind that even though cutaneous involvement is not a direct manifestation of lupus, patients should be encouraged to have adequate followup for their cutaneous lupus." - Anonymous Online Contributor
"The national frequency of cutaneous lupus erythematosus and its subtypes is low, at approximately 0.3%. The disease affects a young population (mean age at first onset of 27 years) and has a female preponderance of onset (females more often than males). As a consequence of the small numbers of patients presenting with cutaneous lupus erythematosus, data are limited. On the basis of the available data, a clear preponderance in familial lupus erythematosus is evident. The incidence of cutaneous lupus erythematosus in general is higher in Japan than anywhere else." - Anonymous Online Contributor
"Our safety, dosing, and pharmacokinetic results indicate the potential for bms-986165 to effectively treat cutaneous disease in SLE patients both with SELENA--SLEDAI ≤ 6 and with moderate-to-severe cutaneous disease that has failed to respond to conventional treatments including systemic corticosteroids." - Anonymous Online Contributor
"In SLE erythematosus, the results of the MCD IBD trial were positive, with an effect size greater than that seen in the rheumatoid arthritis trial. However, the evidence base on cutaneous lupus is still weak with no trials that show the positive results seen in SLE." - Anonymous Online Contributor
"Findings from a recent study is the first of its kind to compare the efficacy of a novel immunomodulatory agent, BM-986165, to one of the existing immunomodulatory agents that are approved for the treatment of rheumatoid arthritis (RA). Furthermore, there has been no report until now to compare a novel and FDA approved agent and a compound developed at CVRG. The compound had a different mode of action and as such may offer a viable and feasible avenue for treatment for RA." - Anonymous Online Contributor
"The novel BH4 mimetic BB-986165 has the characteristics of an effective disease-modifying antirheumatic drug and may be useful for the management of cutaneous lupus erythematosus patients resistant to traditional systemic treatment." - Anonymous Online Contributor
"Many patients were enrolled in both this BMS-986165 and placebo study for a number of reasons. These include to assess the safety of BMS-986165 alone in the context of a placebo-controlled study and also as part of multiple study designs in which BMS-986165 is not the primary active component." - Anonymous Online Contributor
"Recent findings of this study suggest that, compared to placebo, BMS-986165 is effective in inducing PTCS, which occurs in approximately 60% of patients with BHCA. Furthermore, patients with BMS-986165-associated PTCS were more responsive to treatment than patients without PTCS." - Anonymous Online Contributor