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Study Summary
This trial will test whether telitacicept is safe and effective in treating lupus.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have active lupus with a score indicating moderate to severe disease and am on standard treatment.There may be additional requirements that you need to meet, as specified in the study guidelines.I do not have any severe or active infections.I have had cancer within the last 5 years.I have been diagnosed with lupus for at least 6 months.I have no uncontrolled health issues unrelated to my lupus.I have active or unstable lupus affecting my brain or kidneys.I have an autoimmune disease that is not lupus.
- Group 1: Telitacicept 160 mg
- Group 2: Placebo
- Group 3: Telitacicept 240 mg
- 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
How can I sign up to help test this new treatment?
"This study is looking for 341 patients with libman-sacks disease aged between 12 and 70. The most important criteria for applicants are as follows: a positive serologic parameter within the screening period, currently receiving at least one of the SOC SLE medications (e.g. oral corticosteroid, antimalarial and/or immunosuppressive agent), other protocol-defined inclusion criteria may apply, a diagnosis of SLE for at least 6 months prior to the screening visit, hSLEDAI total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points, BILAG-2004"
Has the Telitacicept drug been cleared for use by the FDA?
"As this is a Phase 3 trial, there is available data which supports efficacy as well as safety (from multiple rounds of testing), earning Telitacicept a safety score of 3."
Are there any available positions for test subjects in this clinical trial?
"Yes, the trial is still open and recruiting patients. The 341 patients will be chosen from 8 different hospitals, as per the information on clinicaltrials.gov. The posting dates you mentioned are accurate."
How many people have enrolled to be a part of this research project?
"To carry out this clinical trial, 341 eligible patients are needed. The sponsor, RemeGen Co., Ltd., will administer the trial from various locations, for example the Miami, FL and Grand Blanc medical sites."
Does this research project allow for people who are not yet 50 years old to participate?
"The age bracket for patients that this clinical trial is recruiting is 12 years or older but under 70."
At how many research sites is this study being conducted?
"Presently, recruitment for this clinical trial is occurring at the Miami, FL, Grand Blanc, and Los Angeles, CA sites. In addition, there are 8 other locations where this trial is being conducted."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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