Study Summary
This trial will test if the drug Tofacitinib can help treat people with Lupus.
Eligible Conditions
- Lupus
- Cutaneous Lupus Erythematosus
- Chronic Lung Disease of Early Life (CLE)
- Cutaneous Lupus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 25 Secondary · Reporting Duration: Screening Visit (up to 10 days prior to Day 0,Visit 1), Day 25 (Visit 4, Post-Treatment)
Day 25
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) damage score
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score
Day 25
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) damage score
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score
Day 40
Changes in laboratory parameters
Incidence of adverse events
Day 40
Incidence of Adverse Events
Day 26
Change in Ultraviolet B (UVB)-induced expression of cutaneous inflammatory genes in skin based on enumeration of RNA transcripts
Change in minimal erythema dose (MED) due to Ultraviolet B (UVB)
Change in percentage of Ultraviolet B (UVB)-induced apoptotic epidermal cells
Day 26
Change from Baseline in Ultraviolet B (UVB)-induced expression of cutaneous inflammatory genes in skin based on enumeration of RNA transcripts
Change from Baseline in minimal erythema dose (MED) due to Ultraviolet B (UVB)
Change from Baseline in percentage of Ultraviolet B (UVB)-induced apoptotic epidermal cells
Day 40
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Day 25
Change from Baseline in Absolute White Blood Cell Count (WBC), Absolute Neutrophil Count (ANC), Absolute Lymphocyte Count , and Platelet Count at Day 25
Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase at Day 25
Change from Baseline in Bilirubin, Creatinine, Triglycerides, and Cholesterol at Day 25
Change from Baseline in Complement Component 3 (C3) and Complement Component 4 (C4) at Day 25
Change from Baseline in Erythrocyte Sedimentation Rate at Day 25
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Day 25
Hematocrit procedure
Change from Baseline in Hemoglobin at Day 25
Change from Baseline in Proteinuria Levels at Day 25
Change from Baseline in Urinary Red Blood Cells (RBCs) and Urinary White Blood Cells (WBCs) Detection at Day 25
Change from Baseline in anti-double stranded DNA (anti-dsDNA) at Day 25
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Tofacinitib
1 of 2
tofacitinib XR
1 of 2
Experimental Treatment
10 Total Participants · 2 Treatment Groups
Primary Treatment: tofacitinib XR · No Placebo Group · Phase 1
Tofacinitib
Drug
Experimental Group · 1 Intervention: Tofacitinib · Intervention Types: Drugtofacitinib XRExperimental Group · 3 Interventions: tofacitinib XR, skin biopsy, ultraviolet light B (UVB) phototesting · Intervention Types: Drug, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 4
~36560
skin biopsy
2014
N/A
~930
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening visit (up to 10 days prior to day 0,visit 1), day 25 (visit 4, post-treatment)
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,153 Previous Clinical Trials
4,771,264 Total Patients Enrolled
2 Trials studying Lupus
166 Patients Enrolled for Lupus
Joanne M Kahlenberg, M.D., Ph.D.Study ChairUniversity of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
J. Michelle Kahlenberg, MD, PhDStudy ChairDivision of Rheumatology, Department of Internal Medicine, Michigan Medicine, University of Michigan
Eligibility Criteria
Age 18 - 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have systemic lupus erythematosus disease activity.
You are taking oral corticosteroids, the dose must be < 10 mg daily of prednisone (or equivalent), stable dose for at least 4 weeks, and not anticipated to change over the course of the study.
The study is evaluating whether taking anti-malarial medications may help prevent or treat malaria in children aged 18 years or older.
You are taking methotrexate at a dose of 25 mg weekly
You are taking leflunomide at a dose of 20 mg daily for at least 4 weeks
You are at increased risk for breast cancer if you are younger than 18 years of age or older than 65 years of age.
Who else is applying?
What state do they live in?
| Michigan | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments