A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
This research is looking into a new medicine called Obexelimab for adults who have Systemic Lupus Erythematosus (SLE), often just called lupus. The main goal is to find out if Obexelimab is safe and effective in reducing lupus symptoms. Some participants will receive the active medicine, while others will get a placebo (a dummy medicine with no active ingredients). This is a common way to test new treatments fairly. The study involves giving the medicine as an injection once a week for 24 weeks, followed by a 12-week period where your health will continue to be monitored. Your participation, including initial checks and follow-up, would last about 40 weeks in total.
במבט חטוף
על מה המחקר הזה?
This study is investigating a new treatment called Obexelimab for Systemic Lupus Erythematosus (SLE), commonly known as lupus. Lupus is a long-term condition where the body's immune system mistakenly attacks its own tissues and organs. This can cause a wide range of symptoms, including tiredness, joint pain, skin rashes, and problems with internal organs.
The researchers want to see if Obexelimab can help people with lupus by reducing their symptoms and improving their overall well-being. They will also be carefully monitoring for any side effects to make sure the medicine is safe. Finding new, effective treatments for lupus is very important because it can significantly improve the quality of life for those living with the condition, helping to manage symptoms and prevent complications.
Participants in this study will be closely monitored by a healthcare team throughout the study period. Your contribution could help scientists learn more about lupus and develop better treatments for everyone affected by it in the future.
נקודות עיקריות
- This study is testing a new medicine, Obexelimab, for lupus.
- It aims to see if the medicine is safe and helps reduce lupus symptoms.
- You will receive weekly injections of either the medicine or a placebo for 24 weeks.
- The total study duration, including follow-up, is about 40 weeks.
- Regular visits to the study site for checks will be required.
- ההשתתפות היא בהתנדבות, ואתה יכול לפרוש בכל עת.
מי עשוי להיות זכאי?
To join this study, you need to be an adult between 18 and 70 years old and have had a diagnosis of lupus for at least 24 weeks. Your lupus also needs to be active enough to warrant a new treatment at the start of the study, as judged by your doctors using specific medical scores. You must already be receiving at least one standard lupus treatment, such as steroids, antimalarial drugs, or other immune-suppressing medicines.
There are also some reasons why you might not be able to join. For instance, if you have severe kidney lupus that isn't stable, or if you've had a recent blood clot. Also, if you have another significant inflammatory condition that could make it difficult to properly assess your lupus symptoms, or active severe brain or nerve-related lupus, you might not be eligible.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בין גיל 18 ל-70?
- Have you been officially diagnosed with lupus for at least 24 weeks?
- Is your lupus currently active enough to need more treatment?
- Are you already taking standard lupus medicines (like steroids or antimalarials)?
- Have you had recent blood clots or severe kidney/brain-related lupus?
- Do you have other inflammatory conditions that could make lupus assessment difficult?
מה כרוך בהשתתפות?
If you decide to take part, you'll first have a screening period lasting up to 28 days to confirm you're suitable for the study. Then, you'll enter the main treatment phase, which lasts for 24 weeks. During this time, you'll receive either Obexelimab or a dummy medicine as an injection under your skin once a week. These injections will be given at the study site or you'll be shown how to give them yourself.
You'll need to attend regular appointments at the study site: at week 2, week 4, and then every 4 weeks until the end of the 24-week treatment period. After that, there's a 12-week follow-up period with further visits to check on your health and any long-term effects. Throughout the study, doctors will carry out various checks to see how well the treatment is working and to monitor your safety. Your total time in the study, including all screening and follow-up, will be around 40 weeks.
סיכונים ותועלות פוטנציאליים
Locations (82)
- Sierra Pacific Arthritis and Rheumatology Centersמיקוד מאומתפרזנו, ארצות הברית· גיוס
- California Research Instituteמיקוד מאומתHuntington Park, United States· גיוס
- אוניברסיטת קליפורניה, סן דייגומיקוד מאומתלה הויה, ארצות הברית· גיוס
- Clinical Research of West Florida, Incמיקוד מאומתClearwater, United States· גיוס
- Clinical Research of West Florida, Inc.מיקוד מאומתטמפה, ארצות הברית· גיוס
- Emory Universityמיקוד מאומתאטלנטה, ארצות הברית· גיוס
- Accurate Clinical Researchמיקוד מאומתLake Charles, United States· גיוס
- Henry Ford Hospitalמיקוד מאומתדטרויט, ארצות הברית· גיוס
- June DO, PCמיקוד מאומתLansing, United States· גיוס
- Juno DO, PCמיקוד מאומתLansing, United States· גיוס
- DJL Clinical Research PLLCמיקוד מאומתשארלוט, ארצות הברית· גיוס
- Oklahoma Medical Research Foundationמיקוד מאומתOklahoma City, United States· גיוס
שאלות נפוצות
What is lupus?
Lupus is a condition where your body's immune system mistakenly attacks your own healthy tissues and organs, causing various symptoms.
What is Obexelimab?
Obexelimab is an experimental medicine being tested to see if it can help improve symptoms in people with lupus.
Will I definitely receive the new medicine?
No, you have a 50/50 chance of receiving either Obexelimab or a placebo (dummy medicine) during the main treatment phase.
כמה זמן אהיה במחקר?
Including initial checks and follow-up, your participation will last about 40 weeks in total.
האם אני יכול לעזוב את המחקר אם אשנה את דעתי?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
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