Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356740
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Brief Title:
Efficacy and Tolerance of AbacavirLamivudine Treatment in Patients With Systemic Lupus Erythematosus
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Randomized Pilot Trial to Evaluate the Efficacy and Tolerance of AbacavirLamivudine Treatment in Patients With Systemic Lupus Erythematosus PENCIL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENCIL
Brief Summary:
Systemic lupus SL is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens particularly native double-stranded deoxyribonucleic acid DNA and excessive production of antiviral cytokines type I interferons particularly interferon alpha IFN-α IFN-α production results from the excessive detection of nucleic acids DNA or Ribonucleic Acid RNA by endosomal or intracytoplasmic receptors that are capable of inducing interferon production The precise mechanisms of cytoplasmic sensor activation remain unknown however recent work in the field of interferonopathies suggests a role for human endogenous retroviruses HERVs HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8 of the human genomeSeveral studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons I IFN signalling pathway
To date none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus SLE have been shown to be effective in the background treatment of SL or in preventing relapse Consequently there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies
In this study an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors NRTIs abacavirlamivudine is proposed to treat SLE Thus we propose a pilot Phase II randomized open-label study using NRTIs in patients with SL in remission or with low clinical activity and evaluating a biological endpoint IFN signature which is a direct proxy for the drugs expected effect
The main objective is to compare the addition of AbacavirLamivudine Add-on to standard care for 6 months on the value of the interferon IFN transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State LLDAS
To date none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus SLE have been shown to be effective in the background treatment of SL or in preventing relapse Consequently there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies
In this study an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors NRTIs abacavirlamivudine is proposed to treat SLE Thus we propose a pilot Phase II randomized open-label study using NRTIs in patients with SL in remission or with low clinical activity and evaluating a biological endpoint IFN signature which is a direct proxy for the drugs expected effect
The main objective is to compare the addition of AbacavirLamivudine Add-on to standard care for 6 months on the value of the interferon IFN transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State LLDAS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508611-22-00 | CTIS | None | None |