BMS-986165 for Lupus Erythematosus, Discoid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Local Institution, Los Angeles, CA
Lupus Erythematosus, Discoid+3 More
BMS-986165 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat lupus.

See full description

Eligible Conditions

  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Subacute Cutaneous

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lupus Erythematosus, Discoid

Study Objectives

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.

Up to 56 weeks
Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 60 weeks
Incidence of serious adverse events (SAEs)
Week 16
Mean change from baseline in CLASI-A score
Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16
Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI- 50)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lupus Erythematosus, Discoid

Trial Design

5 Treatment Groups

Active Treatment: Deucravacitinib Dose 2
1 of 5
Active Treatment: Deucravacitinib Dose 1
1 of 5
Active Treatment: BMS-986165 Dose 1
1 of 5
Active Treatment: BMS-986165 Dose 2
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

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.

Active Treatment: Deucravacitinib Dose 2
Drug
Active Treatment: Deucravacitinib Dose 1
Drug
Active Treatment: BMS-986165 Dose 1
Drug
Active Treatment: BMS-986165 Dose 2
Drug
Placebo
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 1
~70
Deucravacitinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 60 weeks for reporting.

Closest Location

Local Institution - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
Participant could be with or without concurrent systemic lupus erythematosus (SLE)
If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

Patient Q&A Section

What is lupus erythematosus, cutaneous?

"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

Unverified Answer

What are common treatments for lupus erythematosus, cutaneous?

"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

Unverified Answer

What are the signs of lupus erythematosus, cutaneous?

"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

Unverified Answer

What causes lupus erythematosus, cutaneous?

"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

Unverified Answer

Can lupus erythematosus, cutaneous be cured?

"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

Unverified Answer

How many people get lupus erythematosus, cutaneous a year in the United States?

"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

Unverified Answer

What is bms-986165?

"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

Unverified Answer

Who should consider clinical trials for lupus erythematosus, cutaneous?

"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

Unverified Answer

Has bms-986165 proven to be more effective than a placebo?

"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

Unverified Answer

How does bms-986165 work?

"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

Unverified Answer

Is bms-986165 typically used in combination with any other treatments?

"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

Unverified Answer

What does bms-986165 usually treat?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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