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Janus Kinase (JAK) Inhibitor
Tofacitinib for Lupus
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 18 to 65 years at screening
Cutaneous lupus erythematosus diagnosed by a rheumatologist or dermatologist as acute, subacute, or chronic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 26
Awards & highlights
Study Summary
This trial will test if the drug Tofacitinib can help treat people with Lupus.
Who is the study for?
This trial is for adults aged 18-65 with systemic lupus erythematosus (SLE) who've had active skin disease within the last 5 years. Participants must be on stable doses of certain medications like methotrexate or hydroxychloroquine, have a low SLEDAI-2K score, and use effective birth control. Those with uncontrolled diseases, recent major surgeries, infections like TB or HIV, or history of thrombosis cannot join.Check my eligibility
What is being tested?
The study tests Tofacitinib in patients with SLE to prevent photosensitivity. It's a single-arm trial involving 10 participants at one site. Patients will receive Tofacitinib under consistent conditions without changing their current medication dosages.See study design
What are the potential side effects?
Tofacitinib may cause side effects such as increased risk of infections, headaches, diarrhea, and potentially serious complications like blood clots or liver issues. The exact side effects experienced can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have been diagnosed with cutaneous lupus by a specialist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in percentage of Ultraviolet B (UVB)-induced apoptotic epidermal cells
Secondary outcome measures
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
+4 moreSide effects data
From 2017 Phase 3 trial • 209 Patients • NCT0228155212%
Nasopharyngitis
1%
Interstitial lung disease
1%
Anaemia
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Immediate Release (IR)
Tofacitinib Modified Release (MR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TofacinitibExperimental Treatment1 Intervention
10 participants receiving 11 mg of Tofacitinib administered orally and daily, from Day 2 to Day 26
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 3
~39970
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,446 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of keloid scarring.I am not taking ketoconazole or similar medications.I have had cancer or lymph-related disorders before.I do not have any uncontrolled serious diseases.I have a history of HIV, hepatitis B, or hepatitis C.I have a long-term lung disease.I have an autoimmune disease that needs treatment to lower my immune system.I have a history of serious heart artery disease.I am fully vaccinated against COVID-19 as per CDC guidelines.I might have a kidney infection or a urinary tract infection.I have had serious stomach or intestine problems.I am between 18 and 65 years old.I am taking, or have recently taken, specific medications.I have received vaccines that are not live.I have received specific previous treatments.I have not taken any corticosteroids through injection or IV in the last 2 weeks.I have a history of chronic infections or was recently exposed to tuberculosis.I have a record of all my vaccinations, including any live vaccines.I have been diagnosed with cutaneous lupus by a specialist.I have not had any active skin conditions in the last 5 years.I have not had major surgery or been hospitalized for a serious infection recently.I have had blood clots, a pulmonary embolism, or antiphospholipid syndrome.I am on specific doses of certain medications like corticosteroids or methotrexate.
Research Study Groups:
This trial has the following groups:- Group 1: Tofacinitib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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