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Cenerimod for Systemic Lupus Erythematosus (OPUS-2 Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system
Currently treated with specific SLE background medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose baseline) to month 12
Awards & highlights
OPUS-2 Trial Summary
This trial will test the effectiveness and safety of cenerimod to reduce symptoms of SLE in adults.
Who is the study for?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been on stable SLE medications for at least a month can join. They must not be pregnant, planning pregnancy, or breastfeeding and agree to regular pregnancy tests and effective contraception if applicable. Excluded are those with certain heart conditions, liver diseases, recent use of specific drugs like rituximab or anifrolumab, severe respiratory issues, cancer history (with exceptions), or major organ involvement by SLE.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Cenerimod compared to a placebo in reducing SLE symptoms over 12 months. Participants will continue their current treatments while adding either Cenerimod or a placebo. The study aims to enroll around 420 participants split evenly between the two groups.See study design
What are the potential side effects?
While specific side effects for Cenerimod aren't listed here, common risks may include immune system changes leading to increased infection risk, potential heart rate reduction given exclusion criteria related to cardiac health, possible liver function alterations due to liver disease exclusions.
OPUS-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus affects at least two organs moderately or one organ severely.
Select...
I am currently on medication for lupus.
Select...
My lupus is active, with significant symptoms affecting my skin or joints.
OPUS-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (pre-dose baseline) to month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose baseline) to month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score
Secondary outcome measures
Response on Systemic Lupus Erythematosus Responder Index (SRI) at Month 12
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations
Side effects data
From 2017 Phase 1 & 2 trial • 105 Patients • NCT024727958%
Tracheobronchitis
8%
Lymphocyte count decreased
8%
Chronic hepatitis
8%
Cough
8%
Blood alkaline phosphatase increased
8%
Tooth extraction
8%
Cataract
8%
Nasopharyngitis
8%
Intraocular pressure increased
8%
Type 2 diabetes mellitus
8%
Periodontitis
8%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cenerimod 4 mg
Cenerimod 0.5 mg
Matching Placebo
Cenerimod 2 mg
Cenerimod 1 mg
OPUS-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cenerimod 4 mgExperimental Treatment1 Intervention
Participants will receive cenerimod once daily in addition to background SLE therapy.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo once daily in addition to background SLE therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenerimod
2015
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
32,037 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,199 Previous Clinical Trials
888,082 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cenerimod 4 mg
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What site did they apply to?
Northwest Houston Arthritis Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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