Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

Status Completed

Clinical Trial Summary

This is a single-arm, single-site, proof-of-concept study that will evaluate the treatment of 10 participants with systemic lupus erythematosus (SLE) who have a history of cutaneous lupus with Tofacitinib.

Clinical Trial Description

Once consented, study participants meeting all entry criteria will undergo 25 days of treatment with tofacitinib (11 mg orally daily). Tofacitinib will be distributed to eligible participants at Visit 2 (Day 1) and the first dose will be taken on Day 2. The last dose is the morning of Visit 5 (Day 26).Ultraviolet B (UVB)-mediated cutaneous apoptosis and ancillary mechanistic studies will be evaluated in phototests, skin biopsies and blood samples collected before and after treatment. This study will assess whether a 25-day regimen of tofacitinib impacts photosensitivity following UVB exposure in individuals with systemic lupus and a history of cutaneous lupus. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05048238
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	September 30, 2022
Completion date	February 29, 2024

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03843125` - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)	Phase 3
Recruiting	`NCT05698173` - Systemic Lupus Erythematosus and Accelerated Aging	N/A
Active, not recruiting	`NCT01649765` - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	Phase 2
Recruiting	`NCT05704153` - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)	N/A
Recruiting	`NCT06056778` - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed	`NCT04358302` - Individual Patient Exposure and Response in Pediatric Lupus	N/A
Completed	`NCT03802578` - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients	N/A
Completed	`NCT02554019` - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT04835883` - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients	Phase 2
Terminated	`NCT02665364` - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00278538` - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00069342` - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed	`NCT03252587` - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus	Phase 2
Terminated	`NCT02066311` - Nelfinavir in Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT01892748` - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	N/A
Terminated	`NCT01689025` - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	Phase 1
Completed	`NCT01475149` - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)	N/A
Unknown status	`NCT01712529` - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients	N/A
Completed	`NCT00962832` - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT00747578` - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan	N/A