What side effects are associated with this type of intervention?

Common treatments for Discoid Lupus, particularly Janus Kinase inhibitors like topical ruxolitinib, can have several side effects. For ruxolitinib, these may include application site reactions, such as redness, itching, and burning. Systemic side effects, although less common with topical application, can include increased risk of infections, headache, and elevated liver enzymes. Other treatments for Discoid Lupus, such as corticosteroids, can cause skin thinning, increased susceptibility to infections, and systemic effects like hypertension and hyperglycemia when used long-term. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the use of Janus Kinase (JAK) inhibitors like Ruxolitinib for the treatment of Discoid Lupus Erythematosus (DLE). Current treatments for DLE typically include topical corticosteroids, antimalarial drugs such as hydroxychloroquine, and immunosuppressive agents. The study of topical Ruxolitinib represents an emerging area of interest, potentially offering a new therapeutic option for patients with refractory DLE.

What other types of research exist?

Promising alternatives to Topical Ruxolitinib for Discoid Lupus patients include: 1) Rituximab, which has shown efficacy in treating lupus-related conditions, including digital ischemia and inflammatory myopathies. 2) Anifrolumab, which has demonstrated positive effects on rash and arthritis in systemic lupus erythematosus. 3) Tacrolimus, which has been used successfully in treating cutaneous lesions in dermatomyositis and lupus. These alternatives have shown potential in clinical studies and case reports.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Discoid Lupus

Phase 2

Waitlist Available

Led By Christopher T Richardson, MD, PhD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maximum body surface area of 20%.

Ability to understand and comply with the protocol and provide informed consent.

Must not have

History of coagulopathy, pulmonary embolism or deep venous thrombosis.

History of cutaneous squamous cell carcinoma localized to the treatment area.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a skin-applied medication called ruxolitinib to see if it helps people with discoid lupus erythematosus, a challenging skin condition. The medication aims to reduce inflammation by blocking specific enzymes involved in the body's immune response. Ruxolitinib has been previously noted for its potential in controlling cutaneous lupus erythematosus.

Who is the study for?

This trial is for adults over 18 with discoid lupus, who have at least one inflamed skin lesion. They must understand the study and speak English. People using certain lupus treatments or with a history of severe skin cancer in the treatment area can't join. Pregnant women, those on strong immune system drugs, or with unstable systemic lupus are also excluded.

What is being tested?

The trial is testing Ruxolitinib cream to see if it's effective for treating discoid lupus erythematosus (DLE). Participants will apply this topical medication to their lesions to evaluate its potential benefits.

What are the potential side effects?

Ruxolitinib may cause application site reactions like redness and itching. Since it affects the immune system, there might be an increased risk of infections. Other side effects could include headaches and changes in blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body surface area is not more than 20%.

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I understand the study requirements and agree to participate.

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I am 18 years old or older.

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 blood clotting issues or clots in my lungs or legs.

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I have had skin cancer only in the area to be treated.

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I have not used JAK inhibitors in the past year.

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I haven't taken any immune system altering drugs, except for antimalarials, recently.

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I have not used UV therapy or tanned in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean change in the severity of disease as measured by the Investigator's Global Assessment

Secondary study objectives

Mean change in erythema index

Mean change in itch symptoms

Mean change in melanin index

+2 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Discoid lupus erythematosusExperimental Treatment1 Intervention

Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1170

0 / 8Eligibility 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 Discoid Lupus Erythematosus (DLE) include topical corticosteroids, antimalarials like hydroxychloroquine, and immunosuppressive agents such as methotrexate. These treatments work by reducing inflammation and modulating the immune response. Topical Ruxolitinib, a Janus Kinase (JAK) inhibitor, specifically targets the JAK-STAT signaling pathway, which is involved in the immune response and inflammation. By inhibiting this pathway, Ruxolitinib can reduce the inflammatory processes that contribute to the skin lesions in DLE. This targeted approach is significant for DLE patients as it offers a potential treatment that directly addresses the underlying immune dysregulation, potentially leading to better management of symptoms and fewer side effects compared to broader immunosuppressive therapies.