More effective treatment options for SLE are urgently needed.
Learn about a research study evaluating an oral investigational drug.Refer a Patient
Enrollment is underway in the Paisley Study, a Phase II research study evaluating an oral investigational drug for systemic lupus erythematosus (SLE). Learn more and consider referring patients to the study.
About the oral investigational drug
An oral Tyrosine kinase 2 (Tyk2) inhibitor for SLE
The investigational drug, BMS-986165, is a highly selective, orally administered, small molecule inhibitor of Tyrosine kinase 2 (Tyk2).
- Experience in nonclinical models supports the potential benefits of treatment with the oral investigational drug for SLE and other immune-mediated conditions1
- Several lines of evidence indicate that Tyk2 inhibition may reduce SLE disease activity2
- Gillooly K, Zhang Y, Yang X, et al. BMS-986165 is a highly potent and selective allosteric inhibitor of Tyk2, blocks IL-12, IL-23 and type I interferon signaling and provides for robust efficacy in preclinical models of systemic lupus erythematosus and inflammatory bowel disease [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/bms-986165-is-a-highly-potent-and-selectiveallosteric-inhibitor-of-tyk2-blocks-il-12-il-23-and-type-i-interferon-signaling-and-provides-forrobust-efficacy-in-preclinical-models-of-systemic-lupus-e/. Accessed August 28, 2017.
- Shao WH, Cohen PL. The role of tyrosine kinases in systemic lupus erythematosus and their potential as therapeutic targets. Expert Rev Clin Immunol. 2014 May;10(5):573–582.
The study is comparing 3 different doses of the oral investigational drug to placebo in patients with moderate to severe SLE.
Study design and requirements
The Paisley Study will evaluate the safety and efficacy of the oral investigational drug in SLE and determine the optimal dose.
- Patient participation will last about 56 weeks
- The treatment period is 48 weeks
- There will be a 28-day follow-up
- Participants are randomized to 1 of 4 groups—there is a 3 out of 4 chance of getting the oral investigational drug
Your patient will be required to:
- Attend all study visits (14 during the treatment period)
- Take the oral investigational drug as directed
- Complete questionnaires on symptoms and details about SLE
Female participants of childbearing potential must use approved method(s) of contraception during the research study and for 33 days after the last investigational drug dose.
Male participants who are sexually active with women of childbearing potential must use approved method(s) of contraception during the research study and for 3 days after the last investigational drug dose.
Key eligibility criteria*
Do you have SLE patients who may be good candidates for this research study?
Key eligibility criteria include:
- Males and females age 18–75 years with moderate to severe SLE for 6 months or more
- Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification for SLE
- Has elevated antinuclear antibodies (ANA) ≥ 1:80 OR positive anti-dsDNA OR positive anti-Smith
- On stable dose of background therapy with immunosuppressants/antimalarials; corticosteroid therapy is permitted but not required
- No drug-induced SLE or other autoimmune disease except for type I autoimmune diabetes mellitus, thyroid autoimmune disease, and secondary Sjӧgren’s syndrome
*For a full list of inclusion/exclusion criteria, please contact the research clinic.
Qualified participants will:
- Receive study-related monitoring by a lupus study team
- Receive investigational drug and all study-related assessments at no cost
- Be reimbursed for any reasonable expenses incurred to attend study visits
With your patient’s permission, the study doctor can keep you apprised of his/her progress during the research study.
Participation in the research study may also help advance medical knowledge about SLE.
Learn more about the Paisley Study
For more information, please contact the following study representative: