What is the mechanism of action of this treatment?

Common treatments for Lupus include glucocorticoids, immunosuppressants, biologics, and Janus kinase (JAK) inhibitors like Tofacitinib. Glucocorticoids reduce inflammation by suppressing the immune system. Immunosuppressants, such as methotrexate, inhibit the proliferation of immune cells. Biologics, like belimumab, target specific proteins involved in the immune response. JAK inhibitors, such as Tofacitinib, modulate the immune response by inhibiting the JAK-STAT signaling pathway, which is crucial for the activation and proliferation of immune cells. These treatments are vital for Lupus patients as they help control the overactive immune system, reduce inflammation, and prevent organ damage, thereby improving quality of life and disease outcomes.

What side effects are associated with this type of intervention?

Common treatments for lupus, particularly those involving Janus kinase (JAK) inhibitors like Tofacitinib, are associated with several side effects. These include an increased risk of infections, including serious infections, and potential development of malignancies. Laboratory abnormalities such as changes in blood cell counts and liver enzymes have also been reported. Other side effects may include headache, nausea, and gastrointestinal disturbances. It is important for patients to discuss these potential risks with their healthcare provider to manage and monitor any adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus, including drugs that modulate the immune response. One such class of drugs is Janus kinase (JAK) inhibitors, which work by inhibiting the JAK-STAT signaling pathway. Tofacitinib is a JAK inhibitor currently being studied for its efficacy in treating systemic lupus erythematosus (SLE). Other FDA-approved treatments for Lupus include biologics like belimumab, which targets B-lymphocyte stimulator (BLyS) to reduce the activity of B cells, and various immunosuppressive agents such as hydroxychloroquine and corticosteroids.

What other types of research exist?

Promising novel alternatives to Tofacitinib for lupus patients include Anifrolumab, which targets the type I interferon receptor, and Rituximab, which targets CD20 on B cells. Both have shown efficacy in clinical trials and offer targeted mechanisms of action.

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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

Must not have

History of keloid scarring

History of lymphoproliferative disorders or malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 26

Awards & highlights

Summary

This trial tests if a short course of tofacitinib can help people with lupus who have skin problems by reducing their sensitivity to UV light. The medication aims to calm the immune system and reduce inflammation.

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.

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.

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 below

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I am between 18 and 65 years old.

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I have been diagnosed with cutaneous lupus by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of keloid scarring.

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I have had cancer or lymph-related disorders before.

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I do not have any uncontrolled serious diseases.

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I have a history of HIV, hepatitis B, or hepatitis C.

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I have a long-term lung disease.

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I have an autoimmune disease that needs treatment to lower my immune system.

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I have a history of serious heart artery disease.

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I have a history of chronic infections or was recently exposed to tuberculosis.

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I might have a kidney infection or a urinary tract infection.

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I have had serious stomach or intestine problems.

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I am taking, or have recently taken, specific medications.

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I have received specific previous treatments.

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I am not taking ketoconazole or similar medications.

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I have not had major surgery or been hospitalized for a serious infection recently.

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I have had blood clots, a pulmonary embolism, or antiphospholipid syndrome.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in percentage of Ultraviolet B (UVB)-induced apoptotic epidermal cells

Secondary study objectives

Change in Ultraviolet B (UVB)-induced expression of cutaneous inflammatory genes in skin based on enumeration of RNA transcripts

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552

10%

Nasopharyngitis

Pneumocystis jirovecii pneumonia

Rectal cancer

Pneumonia

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Tofacitinib Modified Release (MR)

Tofacitinib Immediate Release (IR)

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 4

~32260

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus include glucocorticoids, immunosuppressants, biologics, and Janus kinase (JAK) inhibitors like Tofacitinib. Glucocorticoids reduce inflammation by suppressing the immune system. Immunosuppressants, such as methotrexate, inhibit the proliferation of immune cells. Biologics, like belimumab, target specific proteins involved in the immune response. JAK inhibitors, such as Tofacitinib, modulate the immune response by inhibiting the JAK-STAT signaling pathway, which is crucial for the activation and proliferation of immune cells. These treatments are vital for Lupus patients as they help control the overactive immune system, reduce inflammation, and prevent organ damage, thereby improving quality of life and disease outcomes.

[Neuropsychiatric Systemic Lupus Erythematosus].The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.Novel treatments for systemic lupus erythematosus.