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Arm 1: Deucravacitinib for Lupus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Local Institution - 0103, Lima, PeruLupusDeucravacitinib - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a new drug to treat active Systemic Lupus Erythematosus (SLE) to see if it's safe and effective. #SLE #clinicaltrial

Eligible Conditions
  • Lupus

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Deucravacitinib Dose 1
1
Daxdilimab Arm 2
1
Mycophenolate Mofetil

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Up to 156 weeks

At week 52
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Up to 156 weeks
Number of participants with AEs leading to discontinuation of treatment
Number of participants with AEs leading to study discontinuation
Number of participants with adverse events (AEs)
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with laboratory abnormalities
Number of participants with serious adverse events (SAEs)
Number of participants with target adverse events of interest (AEIs)
Number of participants with target adverse events of special interest (AESIs)
Number of participants with vital sign abnormalities
Up to 52 weeks
Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Deucravacitinib Dose 1
2
Daxdilimab Arm 2
2
Mycophenolate Mofetil

Trial Design

2 Treatment Groups

Arm 1: Deucravacitinib
1 of 2
Arm 2: Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

490 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1: Deucravacitinib · Has Placebo Group · Phase 3

Arm 1: Deucravacitinib
Drug
Experimental Group · 1 Intervention: Deucravacitinib · Intervention Types: Drug
Arm 2: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 1
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 156 weeks

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,514 Previous Clinical Trials
3,944,904 Total Patients Enrolled
3 Trials studying Lupus
793 Patients Enrolled for Lupus

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have lupus headache, hair loss, mental confusion, or mouth sores, it will be noted in your medical record but will not affect your eligibility to participate in the study.
References

Frequently Asked Questions

Am I eligible to enroll in this research study?

"Up to 490 patients with systemic lupus erythematosus between the ages of 18 and 75 will be admitted into this trial. Eligibility criteria include: a positive ANA reading ≥ 1:80, a SLEDAI-2K score ≥ 6 points, clinical SLEDAI 2K score ≥ 4 points with joint involvement and/or rash, a diagnosis of SLE at least 24 weeks before screening, meeting the 2019 EULAR/ACR classification criteria for SLE, and being on one or more background therapies (immunosuppressant and/or antimalarial) for 12 weeks prior" - Anonymous Online Contributor

Unverified Answer

Are there any more positions available for test subjects?

"According to the information readily available on clinicaltrials.gov, this trial is no longer looking for patients as of their last update on November 8th, 2022. This study was initially posted on 21/11/2022. Right now, there are 128 other trials that are actively recruiting patients." - Anonymous Online Contributor

Unverified Answer

Does this research include elderly participants?

"The age requirement for this clinical trial is that patients must be over 18 but under 75 years old." - Anonymous Online Contributor

Unverified Answer

What is the status of Deucravacitinib's FDA approval?

"We believe that arm 1 of the deucravacitinib clinical trial is safe, as it has received a score of 3. This is due to there being data supporting efficacy and safety from multiple rounds of testing." - Anonymous Online Contributor

Unverified Answer

Is this trial taking place in more than one urban location?

"With 21 sites available, patients have plenty of options for participating in this study. Some notable locations include the Arthritis & Rheumatology Research Institute in Allen, Yale University School of Medicine in New Haven, and the University of Florida College of Medicine in Gainesville." - 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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