A Phase 2B Double-Blind Randomized Placebo-Controlled Multicenter Dose-Ranging Study to Evaluate the Efficacy and Safety Profile of PF-06700841 in Participants with Active Systemic Lupus Erythematosus (SLE)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Systemic Lupus Erythematosus
-
Age: Between 18 years - 75 years
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Participants who are willing and able to comply with all the study procedures.
- Have a clinical diagnosis of SLE
- Have serologically positive SLE
- Currently receiving a stable dose of/or have documented failed therapy with one of the following: methotrexate (MTX), azathioprine (AZA), mycophenolate/mycophenolic acid (MMF), anti-malarials (hydroxychloroquine or chloroquine) or corticosteroids (if monotherapy, greater than or equal to 7.5 mg per day)
- Have active disease defined as:
- SLEDAI-2K score of =6 points at screening, and “Clinical” SLEDAI-2K score of =4 points at both screening and randomization
- BILAG Level A disease in =1 organ system
- Participants weighing greater than 35 kg and less than 130 kg
- Capable of giving signed informed consent
You may not be eligible for this study if the following are true:
-
- Have active renal lupus
- Have severe active central nervous system (CNS) lupus
- Have cancer or a history of cancer within 5 years of screening
- Have a history of a major organ transplant
- Have a history of thrombosis
- Have acute coronary syndrome
- Have pre-existing demyelinating disorder
- A history of additional risk factors for torsade de pointes
- A participant with any condition possibly affecting oral drug absorption
- Have a history of lymphoproliferative disease
- 1. Have active fibromyalgia/myofascial/chronic pain that, in the investigator’s opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.