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Janus Kinase (JAK) Inhibitor
Abrocitinib 100 mg tablet (marketed drug) for Atopic Dermatitis
Phase 4
Recruiting
Led By Robert Bissonnette, MD
Research Sponsored by Innovaderm Research Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12
Awards & highlights
Study Summary
This trial will study a drug to see if it helps people with atopic dermatitis.
Who is the study for?
This trial is for adults with atopic dermatitis (eczema) who haven't responded well to dupilumab treatment. Participants must have a history of moderate to severe eczema, no significant flare-ups in the last month, and meet specific criteria regarding skin condition severity. Excluded are those with certain immune disorders, cancer within the past 5 years, serious infections or conditions that could affect results.Check my eligibility
What is being tested?
The study is testing Abrocitinib's effectiveness on individuals with atopic dermatitis who didn't see improvement after using Dupilumab. It's an open-label trial where all participants know they're receiving Abrocitinib without being compared to a placebo or other drug.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of Abrocitinib may include nausea, headache, common cold symptoms (nasopharyngitis), and increased risk of infection due to its immune-modulating properties.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline of Eczema Area and Severity Index (EASI)
Secondary outcome measures
Change from baseline of Body Surface Area (BSA)
Change from baseline of Facial Eczema Area and Severity Index (EASI)
Alzheimer's Disease
+8 moreSide effects data
From 2022 Phase 2 trial • 20 Patients • NCT0503898210%
Headache
10%
Sore throat
10%
Nasal Congestion
10%
Acneiform Eruption
10%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prurigo Nodularis
Chronic Pruritus of Unknown Origin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Abrocitinib 100 mg tablet (marketed drug)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abrocitinib
2021
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Innovaderm Research Inc.Lead Sponsor
48 Previous Clinical Trials
3,156 Total Patients Enrolled
Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.
25 Previous Clinical Trials
2,675 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a male or female subject 18 years of age or older, at the time of consent.You had a moderate to severe case of atopic dermatitis before starting dupilumab treatment.You currently have a serious infection or have recently had one.You have taken abrocitinib before the start of the study.You are allergic to abrocitinib or any ingredients in it.You have been diagnosed with active eczema (atopic dermatitis) based on specific medical standards.You have a history of skin disease or a current skin condition that could affect the study evaluations.You have had cancer in the last 5 years before starting the study.You have a condition called atopic dermatitis (AD) that is moderate to severe in intensity.
Research Study Groups:
This trial has the following groups:- Group 1: Abrocitinib 100 mg tablet (marketed drug)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05602207 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many venues is this medical experiment conducted?
"This trial is currently taking place at 8 different sites, which are located in Québec, Winnipeg, and Montreal among others. To reduce any inconveniences associated with travel, it would be wise to select the site closest to you if you wish to take part."
Answered by AI
Are there any substantial risks associated with Abrocitinib 100 mg tablet consumption?
"Abrocitinib is a clinically approved drug, which leads our team to assign it the maximum safety score of 3 on a scale from 1-3."
Answered by AI
Are participants currently being accepted for this research study?
"According to clinicaltrials.gov, this study is no longer seeking participants as the trial was last updated on November 1st 2022. However, there are 235 other trials that remain active and recruiting patients at present."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
What site did they apply to?
Inno-6050 Site 11
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have tried dermovate but didnt work.
PatientReceived no prior treatments
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