NIH-Sponsored Phase 2 Study in Systemic Lupus Erythematosus (SLE)

Topline data expected in the second half of 2021. This study is sponsored and funded by the National Institute of Allergy and Infectious Diseases through the Autoimmunity Centers of Excellence (ACE) Cooperative Network.

Study Details:

  • Primary Endpoint: Change from baseline in the 7-day average of the maximum daily Numerical Rating Scale Pain score at Week 12 ​ (n = 101)
  • Key Secondary Endpoints: Other evaluations of musculoskeletal pain and disease activity, SLE Responder Index, SELENA-SLEDAI score, BILAG-2004 score, Physician Global Assessment, Lupus Activity Patient Global Assessment and PROMISE-29 score
  • For complete study details, please view the study listing on Identifier: NCT03093402

About Systemic Lupus Erythematosus:

Systemic lupus erythematosus (SLE), a form of lupus, is a systemic autoimmune disease affecting more than 200,000 Americans.1,2 SLE occurs when the immune system is activated and attacks different parts of the body, leading to widespread inflammation in areas such as in a person's joints, skin, kidneys, blood cells, brain, heart, and lungs.2,3 Each person with SLE has slightly different symptoms that can range from mild to severe, depending on which body parts are affected by the disease. Symptoms may include arthritis, extreme fatigue, red rashes, hair loss, sensitivity to the sun, mouth sores, and pale or purple fingers and toes when exposed to cold or stress.2 Although SLE is most often a disease that one can live with for decades, it is ranked among the top 20 leading causes of death in young women.4 Medicines specifically approved by the FDA for treatment of SLE are aspirin, hydroxychloroquine, corticosteroids (for example, prednisone), a repository corticotropin injection, and the immunosuppressive drug belimumab.2 Other drugs that are not FDA-approved for SLE but are often prescribed by physicians include methotrexate, mycophenolate, azathioprine and cyclophosphamide. These treatments may be associated with significant side effects, including serious infections.

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1. Izmirly, et al .“Prevalence of Systemic Lupus Erythematosus in the United States: Estimates from a Meta‐Analysis of the Centers for Disease Control and Prevention National Lupus Registries.” Arthritis & Rheumatology,
2. “Lupus.” Mayo Clinic, 20 May 2021,
3. “Systemic Lupus Erythematosus (Lupus).” National Institute of Arthritis and Musculoskeletal and Skin Diseases, U.S. Department of Health and Human Services, 20 May 2021,
4. Yen, et al. “Brief Report: Lupus-An Unrecognized Leading Cause of Death in Young Females: A Population-Based Study Using Nationwide Death Certificates, 2000-2015.” Arthritis & Rheumatology, doi:10.1002/art.40512