A Clinical Research Opportunity for Adult Patients with Active and Refractory Systemic Lupus Erythematosus, Lupus Nephritis,
or Rheumatoid Arthritis

The Frontier Study aims to assess two study drugs to understand their safety, tolerability and effectiveness on active and refractory systemic lupus erythematosus, lupus nephritis, and rheumatoid arthritis.

Get Started
Protocol A ~ 
Participants must meet the following criteria:
Are between 18 - 75 years old
Have a confirmed diagnosis of Systemic Lupus Erythematosus with Nephritis
  • Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V
Have previously failed at least one immunosuppressive therapy
  • Inadequate response is defined as:
    UPCR ≥ 1.0mg/mg.
Be positive for at least one of the following antibodies:
  • Antinuclear antibodies (ANA) ≥ 1:80
  • Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range      
  • Anti-Smith antibodies elevated to above normal
Participants are not eligible if they:
Have had a previous kidney transplant or planned transplant within study treatment period.
History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment
Renal biopsy showing pure class V.
Get Started
Protocol B ~ 
Participants must meet the following criteria:
Are between 18 - 75 years old
Diagnosis of lupus nephritis or systemic lupus erythematosus
  • For LN: Have previously failed at least two therapies
  • Inadequate response is defined as: 
    UPCR > 1.0 mg/mg for LN
  • For SLE: Have you failed multiple therapies including treatment with a biological agent or       cyclophosphamide.
Be positive for at least one of the following antibodies:  
  • Antinuclear antibodies (ANA) > 1:80
  • Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range     
  • Anti-Smith antibodies elevated to above normal
Participants are not eligible if they:
Have had a previous kidney transplant or planned transplant within study treatment period.
History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment
Get Started
Protocol C~ 
Participants must meet the following criteria:
Are between 18 - 75 years old
A diagnosis of RA according to the 2010 ACR/EULAR classification criteria.
Active disease defined as having all the following criteria:
  • DAS28-CRP > 3.2 at screening
  • At least 1 swollen joint at screening
Refractory disease defined as:
Moderate to severe active disease despite having received treatment with:
  • at least 1 csDMARD, AND at least 2 bDMARDs of different mechanisms of action
    OR
  • 1 bDMARD and at least 1 tsDMARD.
Participants are not eligible if they:
Have history of current inflammatory joint disease other than RA
Functional Class IV as defined by the ACR classification of functional status in RA
Have previous treatment with any of the following:
  • Total lymphoid irradiation
  • Bone marrow transplant
  • T-cell vaccination therapy
  • Natalizumab

Other eligibility criteria apply and will be evaluated by a principal investigator.

Get Started

Protocol A participants will be
expected to:

Visit the study site approximately 10 times over 12 months.   

Protocols B and C participants will be expected to:

Visit the study site approximately 20 times over 12 months.   
Get Started

Next Steps

HCPs play a key role in supporting patients and their families as they decide if clinical research is right for them. If you have a patient who may be interested in this study and may be eligible, you can:

Complete the “Contact PatientWing” form below. We’ll contact you and discuss how your patient can get involved.

Share this study with your patient so they can apply on their own. Provide them with this website Lupus/Lupus Nephritis or Rheumatoid Arthritis so they can read about the study and fill out a pre-screen questionnaire.

If you have patients who may be a good fit for the study, please contact PatientWing!

Contact PatientWing

If you have a patient who may be eligible, we would love to speak with you! Please submit the information below so our team can reach out. There is no obligation to you or your patient, by submitting this form.  
Email Us
studies@patientwing.com
Call Us
213-459-2979
Do you have a patient who may be a good fit for this study?
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