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Janus Kinase (JAK) Inhibitor
Upadacitinib for Hidradenitis Suppurativa (Step-Up HS Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Step-Up HS Trial Summary
This trial will investigate the safety and effectiveness of upadacitinib in treating adults and adolescents with HS who have not responded to anti-TNF therapy. 1328 participants will be enrolled in 275 sites worldwide.
Who is the study for?
Adults and adolescents with moderate to severe Hidradenitis Suppurativa (HS) who haven't improved on anti-TNF therapy can join. They must have HS in at least two areas, been diagnosed for over 6 months, and meet specific lesion counts. Excluded are those with other active skin diseases or recent use of certain drugs.Check my eligibility
What is being tested?
The trial tests Upadacitinib's effectiveness against HS compared to a placebo. It's double-blinded, so participants won't know if they're getting the drug or placebo. The study has three periods: initial treatment phase, adjustment based on results, and long-term extension for up to 68 weeks.See study design
What are the potential side effects?
Potential side effects aren't specified here but may include reactions similar to those seen in its use for other conditions like infections risk increase, liver issues, blood clots, and allergic reactions due to immune system changes.
Step-Up HS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin condition affects at least one area and is moderate to severe.
Select...
I have HS lesions in at least two different body areas.
Step-Up HS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Secondary outcome measures
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Subjects and Adolescent Subjects Age 17 Years Old or Children's DLQI (CDLQI) for Adolescent Subjects Ages 12 to 16 Years Old
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
+4 moreStep-Up HS Trial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Period 3: Long-Term ExtensionExperimental Treatment2 Interventions
Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Group II: Period 2: Group 6 - PlaceboExperimental Treatment1 Intervention
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive placebo once daily for 20 weeks.
Group III: Period 2: Group 5 - Upadacitinib Dose BExperimental Treatment1 Intervention
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose B once daily for 20 weeks.
Group IV: Period 2: Group 4 - Upadacitinib Dose AExperimental Treatment1 Intervention
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose A once daily for 20 weeks.
Group V: Period 2: Group 3 - Upadacitinib Dose AExperimental Treatment1 Intervention
Participants who were randomized to upadacitinib Dose A in Period 1 who did not achieve HiSCR 50 (CNR) at Week 16 will continue to receive upadacitinib Dose A once daily for 20 weeks.
Group VI: Period 2: Group 1 - Upadacitinib Dose AExperimental Treatment1 Intervention
Participants who were randomized to placebo in Period 1 who did not achieve HiSCR 50 (clinical non-responder, CNR) at Week 16 will receive Upadacitinib Dose A once daily for 20 weeks.
Group VII: Period 1: Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive Upadicitinib Dose A once daily for 16 weeks.
Group VIII: Period 1: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo once daily for 16 weeks.
Group IX: Period 2: Group 2 - PlaceboPlacebo Group1 Intervention
Participants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,062 Total Patients Enrolled
11 Trials studying Hidradenitis Suppurativa
1,620 Patients Enrolled for Hidradenitis Suppurativa
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
145,781 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
557 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin condition affects at least one area and is moderate to severe.I have no active skin conditions or infections that could affect my HS assessment.I haven't had cell-depleting therapies like rituximab in the last year or until my B cell count normalized.I haven't taken antibiotics for HS or any chronic inflammation in the last 14 days.I have tried at least one TNF inhibitor for HS for 12 weeks or a non-TNF biologic for 16 weeks without success, or I couldn't tolerate it.I haven't used prescription skin treatments for HS in the last 14 days.I have HS lesions in at least two different body areas.You must have at least 5 of a certain type of blood cells at the start of the study.I have been diagnosed with HS for at least 6 months.You have fewer than 20 draining fistulas when the study starts.
Research Study Groups:
This trial has the following groups:- Group 1: Period 1: Upadacitinib Dose A
- Group 2: Period 1: Placebo
- Group 3: Period 2: Group 1 - Upadacitinib Dose A
- Group 4: Period 2: Group 2 - Placebo
- Group 5: Period 2: Group 3 - Upadacitinib Dose A
- Group 6: Period 2: Group 4 - Upadacitinib Dose A
- Group 7: Period 2: Group 5 - Upadacitinib Dose B
- Group 8: Period 2: Group 6 - Placebo
- Group 9: Period 3: Long-Term Extension
Awards:
This trial has 1 awards, including:- 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.
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT05889182 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what geographic areas is this investigation taking place?
"Presently, 10 separate clinical trial sites are taking on new patients. These clinics span from Fayetteville to Hollywood and beyond. To ensure minimal travel difficulties, it is advised that participants select the closest medical centre for their convenience."
Answered by AI
How many participants are considered eligible for this medical experiment?
"Correct. The clinicaltrials.gov page displays that this trial is in need of participants, which was first created on June 21st 2023 and last modified on the 28th of the same month. A total of 1328 test subjects must be recruited from 10 different locations."
Answered by AI
What potential risks are associated with administering the initial dose of upadacitinib?
"Our Power team has evaluated the safety of Period 1: Upadacitinib Dose A to be a 3, due to multiple rounds of data that support its efficacy as well as its safety."
Answered by AI
Are there any open positions available for participants of this research?
"Affirmative. According to the clinicaltrials.gov data, this study is still open for participant enrolment; it was initially posted on June 21st 2023 and recently edited on June 28th of that same year. 1328 people must be recruited from 10 different trial sites."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
Alabama
What site did they apply to?
Skin Care Research - Tampa /ID# 256440
Vivida Dermatology- Flamingo /ID# 254227
Schweiger Dermatology, P.C. /ID# 254232
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Will it make it worse?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I just want the pain to stop. I be hungry and this is a way to can buy groceries.
PatientReceived 1 prior treatment
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