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Cenerimod for Systemic Lupus Erythematosus (OPUS-2 Trial)
OPUS-2 Trial Summary
This trial will test the effectiveness and safety of cenerimod to reduce symptoms of SLE in adults.
OPUS-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795OPUS-2 Trial Design
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- My lupus affects my brain or nerves severely.I have swelling in my retina or active eye inflammation.I have a history of heart or lung conditions.I have been diagnosed with mixed connective tissue disease or overlap syndromes.My lupus is active, with significant symptoms affecting my skin or joints.I have a history of cancer, lymph disease, or specific radiation treatment.I was diagnosed with lupus more than 6 months ago.I have not taken certain medications recently.My lupus affects at least two organs moderately or one organ severely.I am currently on medication for lupus.I have a history of chronic liver, biliary disease, or significant blood issues.
- Group 1: Cenerimod 4 mg
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do individuals whose age exceeds thirty years qualify for enrollment in this research study?
"This trial is seeking participants who are aged 18 or above, and under 75 years of age."
Has the FDA endorsed Cenerimod 4 mg for therapeutic purposes?
"On a scale of 1-3, the safety rating for Cenerimod 4 mg is 3 due to prior clinical data indicating its efficacy and multiple studies demonstrating its security."
To whom is this clinical trial open for participation?
"To qualify as a participant in this trial, individuals must have systemic lupus erythematosus and range between 18-75 years of age. At present, approximately 420 patients are being sought for recruitment."
How many participants are being included in the research project?
"Affirmative, the information hosted on clinicaltrials.gov demonstrates that this medical trial is still in search of participants. It was originally posted on January 16th 2023 and has been updated most recently on February 17th 2023. At present, 420 individuals are being recruited from a single site."
Are enrollment opportunities still available for this research endeavor?
"Right. According to the information published on clinicaltrials.gov, this medical study is still actively seeking candidates as of February 17th 2021- a full month after it was first posted online. The research team requires 420 patients from 1 location in order to complete the trial's objectives."
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What portion of applicants met pre-screening criteria?
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