Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus

Phase 1

Recruiting

• Conditions: Systemic Lupus Erythematosus (Sle)

• Registration Number: NCT06032923
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

INCLUSION CRITERIA:<br><br>In order to be eligible to participate in this study, an individual must meet all of the<br>following criteria:<br><br>SLE subjects:<br><br> - Female subjects 18 years or older who meets > 3 of 11 modified Am. Coll. of<br> Rheumatology (ACR) (1997) Revised Criteria for SLE and mild/moderate disease<br> activity defined as an SLE Disease Activity Index 2000(SLEDAI 2K) between zero and<br> less than or equal to 14 at screening;<br><br> - If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stable<br> for at least 4 weeks prior to screening;<br><br> - If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine,<br> dose must have been stable for the 12 weeks prior to screening. The max. allowed<br> doses - hydroxychloroquine 400 mg/day, chloroquine phosphate 500 mg/day and<br> quinacrine 100 mg/day;<br><br> - If on immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil,<br> cyclosporine, tacrolimus); dose must have been stable for the 12 weeks prior to<br> screening<br><br> - Subjects of childbearing potential must agree to practice effective birth control<br> for the duration of the study;<br><br> - Stated willingness to comply with all study procedures and availability for the<br> duration of the study;<br><br> - Agreement to adhere to Lifestyle Considerations throughout study duration;<br><br> - Ability of subject to understand and the willingness to sign a written informed<br> consent document.<br><br> - If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at<br> least 6 weeks before the baseline visit.<br><br>Control subjects:<br><br> - Female subjects 18 years or older<br><br> - No history of autoimmune or inflammatory disease<br><br> - If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at<br> least 6 weeks before the blood draw visit.<br><br>EXCLUSION CRITERIA:<br><br>SLE Subjects:<br><br> - Active renal or central nervous system disease or major renal or hepatic<br> dysfunction;<br><br> - Treatment with rituximab, belimumab or any other biologic agent within the 6 months<br> prior to screening<br><br> - Treatment with cyclophosphamide or IVIG within the 6 months prior to screening and<br> or increase in glucocorticoid dose within 4 weeks of screening;<br><br> - Pregnancy or lactation (nursing)<br><br> - Treatment with another investigational drug or other intervention within 6 months of<br> screening<br><br>Control Subjects:<br><br> - Inability to sign consent<br><br> - Pregnancy or nursing<br><br>Pregnant women are excluded from participation on this study. Self-reported pregnancy<br>status may be accepted from female control participants of child-bearing potential for a<br>blood draw which is considered a minimal risk procedure.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point will be to assess the effect of NR on blunting type I IFN signaling and cytokine secretion from placebo vs. NR supplemented subjects in monocytes comparing baseline (visit 1 to visit 3).