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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.
Must not have
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Pivotal Trial
Summary
This trial is testing if a daily pill called upadacitinib can help people with a painful skin condition called hidradenitis suppurativa (HS) who haven't responded to usual treatments. The study will involve adults and teenagers and will check for safety and effectiveness over time. Participants will be randomly given either the medication or a non-active pill, and their progress will be monitored through periodic medical check-ups.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cell-depleting therapies like rituximab in the last year or until my B cell count normalized.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Secondary study objectives
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥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)
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~11250
Placebo
1995
Completed Phase 3
~2670
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
Janus kinase (JAK) inhibitors, such as upadacitinib, work by blocking the activity of enzymes involved in the signaling pathways that lead to inflammation. This is particularly important for Hidradenitis Suppurativa (HS) patients, as the disease is characterized by chronic skin inflammation.
By inhibiting these pathways, JAK inhibitors can reduce the inflammatory response and decrease the formation of painful lesions. Other common treatments include anti-TNF therapies, which target tumor necrosis factor-alpha (TNF-α) to reduce systemic inflammation.
Understanding these mechanisms helps HS patients and their healthcare providers make informed treatment decisions, potentially leading to better disease management.
Management of hidradenitis suppurativa.
Management of hidradenitis suppurativa.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,015 Previous Clinical Trials
517,853 Total Patients Enrolled
13 Trials studying Hidradenitis Suppurativa
2,960 Patients Enrolled for Hidradenitis Suppurativa
ABBVIE INC.Study DirectorAbbVie
440 Previous Clinical Trials
159,133 Total Patients Enrolled
6 Trials studying Hidradenitis Suppurativa
1,897 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
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