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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Alopecia Areata
Phase 2
Recruiting
Led By Michail S Lionakis, M.D.
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
Patients with APECED (genetic or clinical diagnosis) and severe AA (defined as having >=50% total scalp loss at screening per the SALT score).
No present evidence of hair regrowth.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 32
Awards & highlights
Study Summary
This trial is testing whether the study drug ruxolitinib can help hair regrowth in people with APECED-associated AA and if it can improve other symptoms caused by the immune system's attack to the body.
Who is the study for?
This trial is for people aged 12-65 with APECED and severe alopecia areata, meaning they've lost at least half their scalp hair. They haven't seen any hair regrowth recently, haven't treated their alopecia in the last two months, and have had hair loss for over six months. Participants must be up-to-date on vaccinations, willing to use herpes prevention medication and contraception if necessary, and able to give informed consent.Check my eligibility
What is being tested?
The study tests Ruxolitinib's effectiveness in promoting hair regrowth in patients with autoimmune-related severe alopecia areata. Over a period of up to 10 months, participants will take Ruxolitinib orally twice daily for eight months while undergoing various assessments including physical exams, blood tests, tissue samples from the scalp and other areas, as well as telehealth check-ins.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of Ruxolitinib may include infection risk due to immune system suppression (since it's an immunosuppressant drug), liver function changes, high cholesterol levels; headache; weight gain; dizziness; or difficulty sleeping.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have APECED and severe alopecia with over 50% scalp hair loss.
Select...
I have not noticed any new hair growth.
Select...
I have not been treated for AA, or treatments did not work.
Select...
I have APECED and have lost more than half of my scalp hair.
Select...
I have not noticed any new hair growth.
Select...
I am between 12 and 65 years old.
Select...
I understand the study details and can give my consent.
Select...
My alopecia areata hasn't improved with other treatments.
Select...
I have been experiencing hair loss for more than 6 months.
Select...
I am using an intrauterine device for birth control.
Select...
I am between 12 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 32
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 32
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response defined as a 30% improvement from baseline in the Severity of Alopecia Tool (SALT) score at 32 weeks.
Secondary outcome measures
16. Achievement of ClinRO measure for EB hair loss 0 or 1 with =2-point improvement from baseline (among participants with ClinRO measure for EB hair loss =2 at baseline) at week 32.
Achievement of ClinRO measure for EL hair loss 0 or 1 with =2-point improvement from baseline (among participants with ClinRO measure for EL hair loss =2 at baseline) at week 32.
Achievement of SALT30 at week 16.
+14 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%
Paraesthesia
3%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
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%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
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: Ruxolitinib/APECED-AA PatientsExperimental Treatment1 Intervention
All participants receiving IP through this protocol (APECED-AA patients)will receive ruxolitinib.
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?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,167 Total Patients Enrolled
Michail S Lionakis, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
1,288 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to take medication to prevent herpes reactivation.My hair loss diagnosis is uncertain or hard to measure.You have had a bad reaction to ruxolitinib or similar medications in the past.I have or had a skin condition on my scalp other than alopecia areata.I have APECED and severe alopecia with over 50% scalp hair loss.I haven't taken immune-suppressing drugs in the last 3 months, except for low-dose steroids.I am HIV positive.I have not noticed any new hair growth.I have not been treated for AA, or treatments did not work.I am taking more than 10 mg of steroids daily or had a short course of high-dose steroids recently.I am willing to take medication to prevent herpes reactivation.I understand my condition and can give informed consent.My vaccinations are up to date according to CDC guidelines.I have been experiencing hair loss for more than 6 months.I have had a stroke, heart attack, heart failure, or serious infection recently.I have untreated latent TB.You have important abnormal results in your lab tests.I have had serious infections that were not treated.I have an immune system disorder, but it's not APECED.I haven't taken medications that could affect hair growth in the last 2 months.You have had problems with drinking too much alcohol or using drugs in the past 6 months.I have APECED and have lost more than half of my scalp hair.I haven't treated my hair loss in the last 2 months.I have not noticed any new hair growth.I am between 12 and 65 years old.I expect to undergo a major surgery during the study.I have an untreated hepatitis B or C infection.I have had cancer before, but it depends on the type and when.I am not planning to get any live vaccines within a month before starting ruxolitinib.I have not had a serious bacterial infection in the last 3 months, or if I did, it was treated and resolved.I understand the study details and can give my consent.I haven't treated my hair loss in the last 2 months.My vaccinations are up to date according to CDC guidelines.My alopecia areata hasn't improved with other treatments.I have been experiencing hair loss for more than 6 months.I am using an intrauterine device for birth control.I am between 12 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib/APECED-AA Patients
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.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT05398809 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this experiment?
"This trial seeks 70 participants suffering from alopecia areata, between the ages of 12 and 65 to be included."
Answered by AI
Is enrollment for this research endeavor currently available?
"Data on clinicaltrials.gov verifies that this trial, first posted on December 1st 2022, is actively seeking participants. The information concerning the experiment was recently amended on November 25th of the same year."
Answered by AI
Is Ruxolitinib a viable therapeutic option with minimal risk?
"Due to its Phase 2 status, there is some evidence of Ruxolitinib's safety but no data attesting to the efficacy. Consequently, a score of two was assigned on our team at Power's scale from 1-3."
Answered by AI
Does this trial permit individuals under the age of fifty to participate?
"The required age range for this particular experiment is between 12 and 65 years old. Meanwhile, there are 10 trials aimed at minors and 79 focusing on individuals over the retirement age."
Answered by AI
What is the maximum number of participants this clinical trial can accommodate?
"Affirmative. The clinicaltrials.gov website confirms that this medical trial, which was first published on December 1st 2022, is currently recruiting patients from one location and needs to find 70 participants in total."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Virginia
How old are they?
< 18
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I have tried Xeljanz a few years back and it worked. I could not afford the copay’s and all the hair fell out. I want to see if there is a way I can be active in helping to find a cure.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- National Institutes of Health Clinical Center: < 24 hours
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