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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Study Summary
This trial is testing a new treatment for discoid lupus erythematosus, a chronic skin condition.
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.Check my eligibility
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.See study design
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 belowSelect...
My body surface area is not more than 20%.
Select...
I understand the study requirements and agree to participate.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in the severity of disease as measured by the Investigator's Global Assessment
Secondary outcome measures
Mean change in erythema index
Mean change in itch symptoms
Mean change in melanin index
+2 moreSide effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
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
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Blood creatine phosphokinase increased
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
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
~1140
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
836 Previous Clinical Trials
518,083 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,155 Total Patients Enrolled
Christopher T Richardson, MD, PhDPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clotting issues or clots in my lungs or legs.I have had skin cancer only in the area to be treated.Your blood tests show that your kidney or liver function is not normal.I do not have any infections that could risk my safety or interfere with the study.I have used topical treatments for discoid lupus in the last 2 weeks.I haven't taken strong CYP3A4 inhibitors or fluconazole recently.I have no diseases that could affect study results, except stable lupus.I have at least one large, inflamed skin lesion.I have not used JAK inhibitors in the past year.I am allergic to lidocaine or have a history of keloids, so I can't provide a skin biopsy.My body surface area is not more than 20%.Your baseline ECG shows changes that indicate a high risk for a serious heart-related issue.I understand the study requirements and agree to participate.I am 18 years old or older.I haven't taken any immune system altering drugs, except for antimalarials, recently.I do not have skin conditions other than discoid lupus that could affect study assessments.I have been diagnosed with discoid lupus by my doctor.I have not used UV therapy or tanned in the last 2 weeks.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the official stance of the FDA on Ruxolitinib?
"Since this is a Phase 2 trial, meaning that while there is some evidence supporting its safety, there is none yet for efficacy, we have given Ruxolitinib a score of 2."
Answered by AI
Ruxolitinib is usually given to patients who have which medical condition?
"Ruxolitinib is an effective medication for polycythemia vera. Additionally, it has shown to be useful in treating conditions such as hydroxyurea-resistant or intolerant polycythemia and primary myelofibrosis."
Answered by AI
Are there any available spots for potential participants in this research?
"As of right now, this particular trial is not looking for any new patients. However, the study was originally posted on May 4th, 2022 and was edited as recently as May 20th, 2022. Additionally, if you are seeking other studies, there are 128 trials actively recruiting patients with lupus erythematosus discoid and 99 trials for Ruxolitinib that need participants."
Answered by AI
How many patients are included in this research project?
"Unfortunately, this study is not taking patients at the moment. If you are looking for other studies to participate in, there are 128 clinical trials related to lupus erythematosus and discoid currently recruiting and 99 Ruxolitinib trials with open enrollment."
Answered by AI
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