Status:
RECRUITING
Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Systemic Lupus Erythematosus (Sle)
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
Study Description: Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyperresponsiveness. Neutrophils in females have re...
Detailed Description
Study Description: Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyper-responsiveness. Neutrophils in females have r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- SLE subjects:
- Female subjects 18 years or older who meets \> 3 of 11 modified Am. Coll. of Rheumatology (ACR) (1997) Revised Criteria for SLE and mild/moderate disease activity defined as an SLE Disease Activity Index 2000(SLEDAI 2K) between zero and less than or equal to 14 at screening;
- If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stable for at least 4 weeks prior to screening;
- If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, dose must have been stable for the 12 weeks prior to screening. The max. allowed doses - hydroxychloroquine 400 mg/day, chloroquine phosphate 500 mg/day and quinacrine 100 mg/day;
- If on immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus); dose must have been stable for the 12 weeks prior to screening
- Subjects of childbearing potential must agree to practice effective birth control for the duration of the study;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Agreement to adhere to Lifestyle Considerations throughout study duration;
- Ability of subject to understand and the willingness to sign a written informed consent document.
- If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the baseline visit.
- Control subjects:
- Female subjects 18 years or older
- No history of autoimmune or inflammatory disease
- If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the blood draw visit.
- EXCLUSION CRITERIA:
- SLE Subjects:
- Active renal or central nervous system disease or major renal or hepatic dysfunction;
- Treatment with rituximab, belimumab or any other biologic agent within the 6 months prior to screening
- Treatment with cyclophosphamide or IVIG within the 6 months prior to screening and or increase in glucocorticoid dose within 4 weeks of screening;
- Pregnancy or lactation (nursing)
- Treatment with another investigational drug or other intervention within 6 months of screening
- Control Subjects:
- Inability to sign consent
- Pregnancy or nursing
- Pregnant women are excluded from participation on this study. Self-reported pregnancy status may be accepted from female control participants of child-bearing potential for a blood draw which is considered a minimal risk procedure.
Exclusion
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06032923
Start Date
March 13 2024
End Date
August 1 2028
Last Update
June 8 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892