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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
Must not have
Receipt of TNF agents (i.e. Infliximab, adalimumab) or other biologics within 6 weeks prior to baseline
Known infection with HIV, hepatitis B or hepatitis C at screening or randomization. Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are Hepatitis C ab positive will also be excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 12, and 16
Awards & highlights
Summary
This trial tests if Deucravacitinib can help adults with Hidradenitis Suppurativa by reducing inflammation and painful lumps through calming the immune system.
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.
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.
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.
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I agree to use effective birth control during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken TNF inhibitors or other biologic drugs in the last 6 weeks.
Select...
I do not have HIV, hepatitis B, or hepatitis C.
Select...
I started a new hormonal treatment for HS less than 3 weeks ago.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant. I am also not trying to conceive.
Select...
I haven't taken non-biologic treatments for HS, except antibiotics or hormones, in the last 4 weeks.
Select...
I have more than 20 draining fistulas.
Select...
I have a long-term or frequently returning infection.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.
Secondary study objectives
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 study objectives
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.
Changes in ulceration at weeks 4, 8, 12, and 16 compared to baseline.
Side effects data
From 2023 Phase 2 trial • 67 Patients • NCT0487799012%
Upper respiratory tract infection
7%
Tonsillitis
7%
Depression
7%
Colitis ulcerative
7%
COVID-19
2%
Procedural pneumothorax
2%
Cough
2%
Mouth ulceration
2%
Pyrexia
2%
Cardiac failure chronic
2%
General physical health deterioration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ULCERATIVE COLITIS
CROHN'S DISEASE
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses. Common treatments for HS often target the immune system to reduce inflammation and prevent flare-ups.
Biologic agents, such as TNF-alpha inhibitors (e.g., adalimumab), work by blocking specific inflammatory pathways involved in HS. Deucravacitinib, a selective TYK2 inhibitor, targets the TYK2 enzyme, which plays a crucial role in the signaling pathways of several cytokines involved in the inflammatory process.
By inhibiting TYK2, Deucravacitinib can potentially reduce the inflammatory response and improve symptoms in HS patients. Understanding these mechanisms is important for patients as it highlights the rationale behind using immune-modulating therapies to manage their condition effectively.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,680 Previous Clinical Trials
4,125,399 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
852 Previous Clinical Trials
12,930,463 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.
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