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Janus Kinase Inhibitor
Abrocitinib for Sarcoidosis
Phase 2
Recruiting
Led By William Damsky, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of moderate to severe cutaneous sarcoidosis (CSAMI of 10 or greater) with supportive skin biopsy in which other causes of granulomas (infectious, foreign body) have been ruled out
Cutaneous Sarcoidosis Activity and Morphology (CSAMI) activity score greater than or equal to 10 (patients with a CSAMI greater than or equal to 10 have active cutaneous sarcoidosis involving several distinct cutaneous sites, have moderate to severe disease and would otherwise be considered candidates for systemic therapy), or
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
Study Summary
This trial aims to explore if an oral drug can treat moderate to severe sarcoidosis of the skin.
Who is the study for?
Adults with moderate to severe cutaneous sarcoidosis, confirmed by skin biopsy, can join this trial. They must have been on stable medication doses for 3 months if using other treatments and agree to not change these during the study. Women who can get pregnant need a negative pregnancy test and must use birth control. People with certain infections, liver or kidney issues, clotting disorders, cancer (except certain skin cancers), or taking strong drug inhibitors are excluded.Check my eligibility
What is being tested?
The trial is testing abrocitinib 200 mg daily as an oral treatment for patients with moderate to severe cutaneous sarcoidosis. The goal is to see how effective it is in reducing symptoms of the disease when taken once every day.See study design
What are the potential side effects?
Potential side effects of abrocitinib may include increased risk of infections due to immune system suppression, changes in blood tests like platelets or neutrophils which could indicate blood disorders, possible liver function changes and potential interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with severe skin sarcoidosis, confirmed by a biopsy.
Select...
My skin condition is severe and affects many areas, needing systemic treatment.
Select...
My skin condition affects my nose or vision.
Select...
I am willing to undergo skin biopsies, blood tests, and full body photos for 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
Changes in Cutaneous Sarcoidosis Activity and Morphology Instrument (CASMI) score
Secondary outcome measures
Changes in Fatigue Assessment Scale (FAS)
Changes in Patient Reported Outcomes Quality of Life (King's Sarcoidosis Questionnaire)
Changes in Rhinosinustitis Disability Index (RSDI)
+2 moreSide 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?
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,975 Total Patients Enrolled
3 Trials studying Sarcoidosis
21 Patients Enrolled for Sarcoidosis
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,203 Total Patients Enrolled
3 Trials studying Sarcoidosis
5,030 Patients Enrolled for Sarcoidosis
William Damsky, M.D.Principal InvestigatorYale University
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin condition's severity score is 10 or less.I am willing to undergo skin biopsies, blood tests, and full body photos for the study.I have a history of blood clots, including in my veins or lungs.I am able to become pregnant and agree to use birth control and have a negative pregnancy test before starting the medication.My kidneys do not work well.I am not on medications that strongly affect my body's drug processing enzymes.My liver is not working well (severe impairment).I am a woman who can have children and will not use birth control while on the medication.I have not received a live vaccine in the last 2 weeks.My skin condition is severe and affects many areas, needing systemic treatment.I have been diagnosed with Rheumatoid Arthritis.I am 18 years old or older.I have advanced cancer, except for non-melanoma skin cancer which I've treated.I am not pregnant or nursing.I'm sorry, but it seems like you have not provided the complete information for the criterion. Please provide the full criterion, and I will be happy to help you rewrite it in a simplified manner.I have been diagnosed with severe skin sarcoidosis, confirmed by a biopsy.I have not used any topical medications for the last 2 weeks.I've been on a steady dose of my sarcoidosis medication for 3 months and don't plan to change it.I am under 18 years old.I am on low-dose prednisone or methotrexate, but not on strong immune system suppressants.I am taking prednisone (up to 20 mg daily) or methotrexate (up to 15 mg weekly).You currently smoke or have ever used tobacco in the past.My skin condition affects my nose or vision.I have had cancer before, but it was not skin cancer that was successfully treated.I have an untreated stomach ulcer.
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.
Are any volunteers being accepted to partake in this trial?
"Clinicaltrials.gov reveals that this particular trial, initially made available on February 1st 2023 and last updated January 24th of the same year, is no longer accepting participants; however, there are still 32 other trials actively recruiting eligible candidates."
Answered by AI
What data is available regarding the security of taking Abrocitinib 200 mg daily?
"The safety of Abrocitinib 200 mg daily is estimated to be a 2, as there exists some evidence that suggests it's safe but no proof yet of its efficacy."
Answered by AI
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