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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Alopecia Areata
Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented clinical diagnosis of Alopecia Areata (AA) for at least 6 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 56
Awards & highlights
Study Summary
This trial is testing a new drug for Alopecia Areata, to see if it is better than placebo at improving hair growth after 24 weeks.
Who is the study for?
This trial is for adults with Alopecia Areata who've had the condition for at least 6 months, with current hair loss affecting over half their scalp and stable for the past 6 months. They should have a SALT score of at least 50, indicating significant hair loss. Those with other types of hair loss or skin conditions that could affect scalp assessment can't participate.Check my eligibility
What is being tested?
The study is testing Deucravacitinib's effectiveness compared to a placebo in improving symptoms by Week 24. Participants will be randomly assigned to receive either Deucravacitinib or a placebo, allowing researchers to measure the drug's true impact on Alopecia Areata.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to Deucravacitinib which will be closely monitored against those taking the placebo for safety and tolerability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alopecia Areata for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alopecia
Number of Participants with AEs Leading to Study Discontinuation
Number of Participants with AEs of Interest (AEIs)
+6 moreSecondary outcome measures
Proportion of Participants with a SALT Score ≤ 20 at Week 24
Proportion of Participants with an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 with at least a 2-Point Change from Baseline
Proportion of participants with a ≥ 50% reduction in SALT Score (SALT50 Response) from Baseline at Week 24
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Deucravacitinib Dose 2Experimental Treatment2 Interventions
Group II: Deucravacitinib Dose 1Experimental Treatment2 Interventions
Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,645 Previous Clinical Trials
4,130,909 Total Patients Enrolled
1 Trials studying Alopecia Areata
15 Patients Enrolled for Alopecia Areata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have skin conditions on my scalp that could affect hair loss evaluation.You have a high score for scalp hair loss, and if you have complete scalp hair loss, you may still be included.My current scalp hair loss has lasted at least 6 months but not more than 8 years, and hasn't improved significantly in the last 6 months.You have a SALT score of at least 50, which measures the amount of scalp hair loss. If you have complete scalp hair loss (SALT score of 100), with or without body hair loss, you can still participate.You have a lot of tattoos on your scalp that could make it hard for the doctor to measure your skin condition accurately.I have a type of hair loss such as diffuse AA or traction alopecia.I have been diagnosed with Alopecia Areata for at least 6 months.My scalp hair loss has lasted at least 6 months but not more than 8 years, and hasn't improved significantly in the last 6 months.I have been diagnosed with Alopecia Areata for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Deucravacitinib Dose 1
- Group 2: Deucravacitinib Dose 2
- Group 3: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
Awards:
This trial has 0 awards, including: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: NCT05556265 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals included in the parameters of this investigation?
"The study has established a recruitment age criteria of 18 to 65."
Answered by AI
Which sites are presently hosting this research project?
"Fifteen medical centres are participating in this trial, with Local Institution - 0034 located in Montreal, Oregon Medical Research Center stationed in Portland, and Local Institution - 0009 based out of Peterborough being among them."
Answered by AI
Is it possible for me to be involved in this medical experiment?
"This clinical trial is seeking 90 individuals aged 18-65 who have been clinically diagnosed with alopecia areata for at least 6 months. To be eligible, participants must meet a minimum SALT score of 50, and their current hair loss episode must not exceed 8 years and the scalp hair loss has to remain stable over the last 6 months (no significant spontaneous regrowth). Even those with complete scalp baldness may qualify if they have body hair involvement."
Answered by AI
Is participation in this trial open to the public right now?
"As per the clinicaltrials.gov database, this medical trial is no longer recruiting participants at present time. Initially posted on November 3rd 2022, and most recently updated October 31st 2022, it is not actively looking for patients; however, there are 85 other studies that have open enrollment now."
Answered by AI
What can be anticipated from taking Deucravacitinib Dose 2 regarding adverse effects?
"There is limited data surrounding the safety of Deucravacitinib Dose 2, prompting our team at Power to assign it a score of 2. This medical trial is currently in Phase 2, so there has been no evidence demonstrating efficacy yet."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
Florida
Georgia
Other
What site did they apply to?
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Forward Clinical Trials
Midwest Center for Dermatology and Cosmetic Surgery - Clinto
Other
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
I have been trying everything and it is just getting worse and worse. As of now it better for a little.
PatientReceived 2+ prior treatments
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