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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Cutaneous Lupus Erythematosus

Phase 2

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 weeks

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of an experimental drug to a placebo in people with lupus erythematosus.

Who is the study for?

This trial is for individuals with active discoid or subacute cutaneous lupus erythematosus (DLE/SCLE) who have been diagnosed at least 3 months prior and are on a stable treatment regimen. It includes those with or without systemic lupus erythematosus (SLE), but excludes pregnant women, those with certain other autoimmune diseases, drug-induced CLE/SLE, severe neuropsychiatric SLE, or a history of multiple unexplained pregnancy losses.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in participants with moderate to severe DLE/SCLE that's not well-managed by current treatments. The goal is to see if Deucravacitinib can improve skin conditions in these patients.See study design

What are the potential side effects?

While specific side effects for Deucravacitinib aren't listed here, common side effects may include nausea, headaches, possible skin reactions at the site of application or ingestion-related discomforts such as stomach pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with DLE/SCLE for at least 3 months.

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I am on a stable treatment plan for my skin condition with medication like corticosteroids, antimalarials, or immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at week 16

Secondary outcome measures

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

+14 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Treatment: Deucravacitinib Dose 2Experimental Treatment1 Intervention

Group II: Active Treatment: Deucravacitinib Dose 1Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

Not yet FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,639 Previous Clinical Trials

4,128,957 Total Patients Enrolled

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04857034 — Phase 2

Discoid Lupus Erythematosus Research Study Groups: Placebo, Active Treatment: Deucravacitinib Dose 1, Active Treatment: Deucravacitinib Dose 2

Discoid Lupus Erythematosus Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT04857034 — Phase 2

Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857034 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of institutions administering this clinical trial?

"Currently, 16 different sites are recruiting for this clinical trial. Sites can be found in Ann Arbor, Oklahoma City and Durham as well as a few other areas. To reduce any transportation difficulties if you decide to join the study, it is advised that you select the location closest to your home."

Answered by AI

Is this pioneering clinical trial charting new territory?

"Deucravacitinib has been investigated since 2018, with the first trial sponsored by Bristol-Myers Squibb. This 240 patient study granted deucravacitinib its Phase 2 approval in that year. Currently, 11 active studies are recruiting patients from 401 cities and 36 countries worldwide."

Answered by AI

To what extent is Deucravacitinib a secure treatment option?

"Our team at Power judged deucravacitinib's safety to be a 2, as Phase 2 trials only provide partial evidence of the drug's effectiveness and no data related to its efficacy."

Answered by AI

What is the aggregate sum of participants engaged in this medical trial?

"Affirmative. The clinical trial is open to applicants and the information hosted on clinicaltrials.gov substantiates this fact, noting that it was first posted on July 12th 2021 with a recent update from October 21st 2022. 75 participants are sought after by 16 medical sites."

Answered by AI

Is this clinical trial open to participants of under-40 age?

"This research study is inviting patients aged 18 and over, up to 75 years of age."

Answered by AI

Could you provide examples of other experiments that have been conducted with Deucravacitinib?

"Deucravacitinib was first studied in 2018 at H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia and has since been the subject of 18,348 completed trials. Currently, 11 investigations are ongoing with many concentrated around Ann Arbor, Michigan."

Answered by AI

Who is the optimal demographic for enrolling in this experiment?

"To be deemed eligible for this medical trial, candidates must have lupus erythematosus or discoid and should fall between 18-75 years old. At present, roughly 75 study subjects are being sought out."

Answered by AI

Are there any opportunities for participants to join this experimental program?

"Affirmative. The publically available information on clinicaltrials.gov corroborates that the trial, initially posted on July 12th 2021, is proactively recruiting patients. Seventy-five participants need to be found from 16 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

2021. "A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04857034.

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