Nelfinavir in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02066311
• Date of registration: 12/02/2014
• Prospective Registration: Yes
• Primary sponsor: Northwell Health
• Public title: Nelfinavir in Systemic Lupus Erythematosus NISLE
• Scientific title: Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial
• Date of first enrolment: September 2014
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02066311
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Meggan Mackay, MD
• Affiliation: Northwell Health

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is capable of providing written informed consent

2. Subject is = 18 years old and = 65 years old

3. Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised
Criteria for the Classification of Systemic Lupus Erythematosus

4. Has mild to moderate disease activity defined as

- A minimum SLEDAI score of 2 excluding points for serology (anti-dsDNA antibody
and complement)

- No active renal or nervous system disease

- No BILAG A in any organ system

- No expectation by the investigator that corticosteroids will need to be added or
doses increased during the 8 week treatment period for any reason

- No expectation by the investigator that immunosuppressive medication will need to
be added or doses increased during the 8 week treatment period

5. Has elevated titers of anti-ds DNA antibody at the time of screening (defined as the
titer that meets criteria for "high" in the Core Laboratory at the North Shore/LIJ
Health Systems; unequivocal high titer as opposed to borderline, indeterminate or
intermediate).

6. Has elevated titers of cross-reactive anti-DNA/DWEYS antibodies at the time of
screening (the assays for anti-DNA/DWEYS antibodies will be performed in Dr. B.
Diamond's laboratory; study sites will be notified of results within 3 days of receipt
of the samples).

7. If on glucocorticoids, the dose must be =10 mg daily and stable for the 4 weeks prior
to screening and baseline

8. If on immunosuppressive or immunomodulatory medication such as azathioprine,
methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must have
been stable for the 3 months prior to screening, and expected to remain stable over
the course of the study.

9. Males and females with potential for reproduction must agree to practice effective
birth control measures (2 approved methods of contraception). Nelfinavir can decrease
serum levels of oral contraceptives; the slightly increased risk of pregnancy due to
an interaction between oral contraception and nelfinavir will be discussed when
appropriate and the requirement for a second approved method of contraception will be
addressed.

Exclusion Criteria:

1. Current or prior treatment with rituximab, belimumab or anti-CD22 monoclonal antibody
in the 12 months prior to this study or any other biologic agent for 90 days prior to
this study

2. Treatment with cyclophosphamide within the 6 months prior to screening

3. Increase in glucocorticoid dose within 4 weeks of screening or addition of a DMARD in
the three months prior to study

4. A history of drug or alcohol abuse within the 6 months prior to screening

5. Elevated LFT's:

- ALT or AST = 2 x upper limit of normal at screening

- serum unconjugated bilirubin > 3mg/dL at screening

6. Dialysis or serum creatinine >1.5mg/dL

7. Hypercholesterolemia: total cholesterol >230 mg/dL or LDL >150 mg/dl or
hypertriglyceridemia (triglyceride >200mg/dL) at screening

8. Laboratory/clinical evidence of: pancreatitis: amylase/lipase >3x upper limit of
normal at screening

9. Known current/active infections including HIV, Hepatitis B, Hepatitis C

10. History of cancer, excluding skin cancers (squamous cell or basal cell that have been
treated)

11. Known active tuberculosis or untreated tuberculosis

12. Hemoglobin < 8 g/dL

13. Expectation by the investigator to increase corticosteroid or immunosuppressive, or
immunomodulatory medication dose at screening, baseline, or over the course of the
study

14. Pregnancy or lactation

15. Consumption of > 2 cups of grapefruit juice per day

16. Treatment with medications metabolized using the cytochrome P3A4 pathway, such as
cyclosporine, tacrolimus, gemfibrozil, niacin, itraconazole, ketoconazole,
erythromycin, azithromycin, clarithromycin, bosentan, nefazodone, tricyclic
antidepressants

17. Any condition that, in the opinion of the Investigator, would jeopardize the subject's
safety following exposure to the study drug.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Nelfinavir

Primary Outcome(s)

Inhibition of Anti-dsDNA Binding [Time Frame: baseline to Day 56]

Secondary ID(s)

NISLE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Results

• Results available: Yes
• Date Posted: 24/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02066311