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Janus Kinase Inhibitor
Abrocitinib for Granuloma Annulare
Phase 2
Waitlist Available
Led By William Damsky, M.D.
Research Sponsored by William Damsky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits
Females of childbearing potential must agree to use birth control during the study and have a negative pregnancy test documented prior to starting the medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
Study Summary
This trial will test if abrocitinib can treat granuloma annulare, an inflammatory skin disease without FDA approved treatment. 10 patients will take it for 6 months to measure % change in BSA.
Who is the study for?
Adults over 18 with Granuloma Annulare covering at least 5% of their body, who've had a confirming skin biopsy. They must stop other GA treatments before starting the trial and agree to birth control if they can have children. Not for current or past smokers, pregnant/nursing women, those with certain infections or serious health conditions like heart attack history, uncontrolled ulcers, severe liver/kidney issues, blood disorders or clotting problems.Check my eligibility
What is being tested?
The trial is testing Abrocitinib 200 mg daily for six months on patients with moderate to severe Granuloma Annulare. The main goal is to see how much it reduces the affected skin area. Participants will undergo regular clinic visits and agree to procedures like skin biopsies and blood tests.See study design
What are the potential side effects?
While not explicitly listed in your information provided, common side effects of JAK inhibitors like Abrocitinib may include headache, high blood pressure, increased cholesterol levels, upper respiratory tract infections and nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to undergo skin biopsies, blood tests, and body photography for the study.
Select...
I am able to become pregnant and agree to use birth control and have a negative pregnancy test before starting the study medication.
Select...
My skin biopsy confirms I have granuloma annulare.
Select...
I have stopped my systemic or phototherapy for GA 4 weeks ago and will not use them during the study.
Select...
At least 5% of my body surface area is affected.
Select...
I have stopped my topical GA treatments for 2 weeks and will not use them during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage Change in BSA involvement by active GA
Secondary outcome measures
Changes in Granuloma Annulare Severity and Morphology Instrument (GASMI) score
Changes in Skindex-16 (Skin related quality of life index)
Changes in molecular signatures in skin and blood before and after treatment
Side effects data
From 2021 Phase 3 trial • 727 Patients • NCT0434536719%
Nausea
13%
Headache
13%
Acne
5%
Dermatitis atopic
4%
Blood creatine phosphokinase increased
4%
SARS-CoV-2 test positive
4%
COVID-19
4%
Nasopharyngitis
3%
Folliculitis
3%
Natural killer cell count decreased
3%
Fatigue
3%
Upper respiratory tract infection
3%
Dizziness
3%
Vomiting
3%
Herpes simplex
2%
Epistaxis
2%
Urinary tract infection
2%
Weight increased
2%
Oral herpes
2%
Diarrhoea
2%
Conjunctivitis
2%
Herpes zoster
1%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abrocitinib 200 mg QD
Dupilumab 300 mg Q2W
Trial Design
1Treatment groups
Experimental Treatment
Group I: Abrocitinib 200 mg dailyExperimental Treatment1 Intervention
6 months of treatment with abrocitinib 200 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abrocitinib 200 mg
2020
Completed Phase 3
~730
Find a Location
Who is running the clinical trial?
Yale UniversityOTHER
1,848 Previous Clinical Trials
2,737,808 Total Patients Enrolled
1 Trials studying Granuloma Annulare
15 Patients Enrolled for Granuloma Annulare
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,876 Total Patients Enrolled
1 Trials studying Granuloma Annulare
15 Patients Enrolled for Granuloma Annulare
William DamskyLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver problems.I am under 18 years old.I am 18 years old or older.I have had cancer before, but it was not skin cancer treated successfully.I am able to become pregnant and agree to use birth control and have a negative pregnancy test before starting the study medication.I have an untreated stomach ulcer.My skin biopsy confirms I have granuloma annulare.My kidneys do not work as well as they should.I have stopped my systemic or phototherapy for GA 4 weeks ago and will not use them during the study.I am willing to undergo skin biopsies, blood tests, and body photography for the study.I have HIV, hepatitis B or C, or a serious infection like herpes or pneumonia.My blood tests show I might be at risk for the treatment.You have tested positive for tuberculosis.I have not received a live vaccine in the last 2 weeks and won't during or 2 weeks after treatment.I am not on strong immune system suppressing drugs, except possibly methotrexate or low-dose prednisone.I have had a heart attack or stroke in the past.At least 5% of my body surface area is affected.I am a woman who can have children and will not use birth control while on the medication.I am not on medications that strongly affect my body's drug processing enzymes.I have stopped my topical GA treatments for 2 weeks and will not use them during the study.You currently smoke or have ever used tobacco.I have a history of blood clots in my veins or lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Abrocitinib 200 mg daily
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned Abrocitinib 200 mg on a daily basis?
"Abrocitinib 200 mg daily was given a score of 2, as it has yet to definitively prove efficacy but there is data available demonstrating safety."
Answered by AI
Is this research experiment accepting new participants?
"According to the clinicaltrials.gov website, recruitment for this trial has already closed; originally posted on February 1st 2023 and last updated December 6th 2022. Nonetheless, there are 16 other studies open to patients at present."
Answered by AI
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