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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Hidradenitis Suppurativa
Phase 2
Recruiting
Led By Alexandra Kimball, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have HS lesions in 2 distinct anatomical areas
Male or Female at least 18 -70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 12, and 16
Awards & highlights
Study Summary
This trial will study a new drug for treating Hidradenitis Suppurativa (HS) in 30 patients aged 18 and over.
Who is the study for?
Adults aged 18-70 with Hidradenitis Suppurativa (HS), having at least 5 abscesses or nodules and lesions in two areas. Women must test negative for pregnancy and use birth control; men cannot be trying to conceive. Excludes those with uncontrolled conditions, recent certain treatments, allergies to tetracycline antibiotics, active skin diseases that could affect HS assessment, current malignancy or history of one within the past five years (except specific treated cancers), chronic infections including HIV/Hepatitis B/C, and those on opioid analgesics.Check my eligibility
What is being tested?
The trial is testing Deucravacitinib's safety and effectiveness against a placebo in treating HS. Participants will randomly receive either Deucravacitinib (6 mg twice daily) or a placebo for 16 weeks. The study includes a screening period before treatment starts and follows up four weeks after the last dose via phone call.See study design
What are the potential side effects?
While not specified here, potential side effects of Deucravacitinib may include infection risk increase due to immune system changes, liver issues, high blood pressure, headaches or dizziness. Side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have HS lesions in two different body areas.
Select...
I am between 18 and 70 years old.
Select...
I agree to use effective birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 8, 12, and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, and 16
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 in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.
Secondary outcome measures
Changes in Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, 12, and 16 compared to baseline.
Changes in Hurley Stage scores at weeks 4, 8, 12, and 16 compared to baseline.
Changes in IHS4 scores at weeks 4, 8, 12, and 16 compared to baseline.
+2 moreOther outcome measures
Change from baseline in draining fistula counts at week 16.
Change in clinical phenotype at week 16 compared to baseline.
Changes in lesion counts (A, N, AN) at weeks 4, 8, and 12 compared to baseline.
+1 moreSide effects data
From 2022 Phase 3 trial • 220 Patients • NCT0416746218%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Week 0 up to Week 16
BMS-986165 Week 0 up to Week 52
BMS-986165 Week 16 up to Week 52
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Deucravacitinib - Study DrugExperimental Treatment1 Intervention
Deucravacitinib group: 6 mg po bid x 16 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo group: 1 tablet po bid x 16 weeks
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 SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,034 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,242 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
21 Patients Enrolled for Hidradenitis Suppurativa
Alexandra Kimball, MD, MPHPrincipal InvestigatorBeth Israel Deaconess Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that weakens your immune system and makes it risky for you to receive immunotherapy.I haven't taken TNF inhibitors or other biologic drugs in the last 6 weeks.I have not taken any oral antibiotics in the last 3 weeks, or I have been on a stable dose for 4 weeks.I have HS lesions in two different body areas.I do not have HIV, hepatitis B, or hepatitis C.I started a new hormonal treatment for HS less than 3 weeks ago.I have not had kenalog injections in the last 2 weeks.You are allergic to tetracycline antibiotics.I have used topical steroids or antibiotics for my skin condition for 2 weeks.I am not pregnant, breastfeeding, nor planning to become pregnant. I am also not trying to conceive.You had a bad reaction to deucravacitinib or any of its parts before.I am between 18 and 70 years old.I haven't taken non-biologic treatments for HS, except antibiotics or hormones, in the last 4 weeks.I have more than 20 draining fistulas.I haven't had cancer, except for non-dangerous skin or cervical cancer, in the last 5 years.I have a long-term or frequently returning infection.You have at least 5 abscesses and/or inflammatory nodules at the start of the trial.I agree to use effective birth control during the study.I have tested negative for TB recently or have treated latent TB.I have taken pain medication for HS within the last 3 days but my non-HS pain meds have been stable for 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Deucravacitinib - Study Drug
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 or over eligible to participate in this clinical trial?
"This medical research is open to volunteers aged 18 and above but below the age of 70."
Answered by AI
Are there any open slots available for participation in this clinical trial?
"Per the information posted to clinicaltrials.gov, this particular trial is not currently enrolling participants. The study began on December 1st 2023 and was last updated August 10th of that year; nonetheless, there are 38 other medical trials actively seeking patient enrollment as we speak."
Answered by AI
Has the FDA sanctioned Deucravacitinib - Study Drug for usage?
"The safety of Deucravacitinib - Study Drug is rated a 2. This assessment comes from our team at Power, based on the fact that this medication has been trialled in Phase 2 clinical trials; thus, there are data supporting its safety but not efficacy."
Answered by AI
How can I become a participant in this medical experiment?
"This clinical trial is accepting up to 30 applicants who have hidradenitis suppurativa and are within 18-70 years of age."
Answered by AI
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