This is a clinical trial for
Patients with lupus
This study is for people with CLE (cutaneous lupus erythematosus) and/or SLE (systemic lupus erythematosus). People with certain types of lupus may experience skin rashes, sores, scarring, or inflammation. The investigational drug in this study targets the specific cells involved in causing these skin symptoms. This study will evaluate the safety of the drug and whether it may reduce these skin issues in patients with CLE, and may decrease overall lupus symptoms, such as fatigue and joint pain, in patients
The study drug (BIIB059) is administered by IV Injection (IV).
This is a phase 2 trial. What does this mean? A phase 2 trial means that the study drug has been taken by other participants under the supervision of medical professionals.
There will be 290 participants in this trial, at 29 sites around the world
- be between 18 – 75 years old
- Have a diagnosis of SLE (systemic lupus erythematosus) and/or CLE (cutaenous lupus erythematosus)
- Have a current skin issue due to lupus
Participants must not:
- Have lupus nephritis or chronic kidney disease
- Be taking certain biologic medications
- Other ineligibility criteria may apply
This trial is 40 weeks long, requiring 13 visits and 0 overnight stays.
A placebo is being used for this trial.
The sponsor of this trial is Biogen.
The results of this trial will be published.
Patients will not be able to continue taking the medication after the trial.
All study related medications, analysis, hospital visits, and procedures are free.
This study will take place in 1 country
29 sites will be participating.
- Boston, Brigham & Women's Hospital, 02115
- Pittsburgh, UPMC Department of Dermatology, 15213
- Ridgewood, The Valley Hospital, 07450
- Summit, Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center, 07901
- Orlando, Omega Research Debary, 32804
- Orlando, Compass Research, LLC, 32806
- Miami Lakes, Lakes Research, LLC., 33014
- Clearwater, Clinical Research of West Florida - Corporate, 33765
- Washington, DC VAMC, 20422
- Washington, GW Medical Faculty Associates Department of Dermatology, 20037
- Anniston, Pinnacle Research Group LLC, 36207
- Meridian, Advanced Clinical Research, 83642
- Tustin, Robin K. Dore, MD Inc, 92780
- Hemet, Dr. C.V. Mehta Medical Corp, 92543
- Irvine, UC Irvine, Dermatology Clinical Research, 92697-1385
- El Cajon, TriWest Research Associates, LLC, 92020
- Fountain Valley, Tien Q Nguyen MD Inc dba First OC Dermatology, 92708
- Upland, Inland Rheumatology Clinical Trials, Inc., 91786
- Los Angeles, Dermatology Research Associates, 90045
- San Diego, University Clinical Trials, 92123
- Wilmington, PMG Research of Wilmington, LLC, 28401
- Chapel Hill, University of North Carolina at Chapel Hill, School of Med, Thurston Arth. Res. Ctr, 27599
- Greensboro, Medication Management, LLC, 27410
- Gahanna, Ohio State University Clinical Trials Management Office, 43230
- St. Louis, Washington University, 63110
- Beaumont, Pioneer Research Solutions, Inc., 77702
- Houston, Accurate Clinical Research, Inc., 77034
- Indianapolis, Dawes Fretzin Clinical Research Group, LLC, 46256
- Albuquerque, Albuquerque Center For Rheumatology, 87102
Frequently asked questions
What are clinical trials?
Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.
Can I quit a trial?
You can quit a clinical trial at any time and you do not have to give a reason. There is no charge or penalty for quitting.
Why participate in a clinical trial?
You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
What are the benefits and risks of clinical trials?
You may or may not receive direct clinical benefit from this study but your participation will provide important information to help researchers learn more about the condition and possibly develop better treatments for future patients.
Is my information safe?
The Study Information is used only for research purposes and will be kept confidential within the limits of the law of your country. If the results of this study are published or presented in a meeting, you will not be named and nobody will be able to tell that you were in the study from the publication or presentation.
Any other questions?
If you would like to speak to someone regarding this trial fill in this quick questionnaire. If you are eligible someone from the research team will contact you by phone and explain everything in more detail.
You are under no obligation to proceed even if you fill it in and can drop out at any point.