What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS), particularly Janus kinase (JAK) inhibitors like Upadacitinib, can cause side effects such as acne, upper respiratory infections, nasopharyngitis, headache, and elevated creatine phosphokinase. Serious side effects may include increased risk of serious infections, major cardiovascular events, cancer, thrombosis, and death. Anti-TNF therapies, another treatment option for HS, can lead to loss of efficacy over time, generalized arthralgias, and increased risk of infections.

What prior FDA approvals exist?

Hidradenitis Suppurativa (HS) has seen various treatments, but the focus on Janus kinase (JAK) inhibitors is relatively new. Upadacitinib, a JAK inhibitor, is currently being studied for HS treatment. Other JAK inhibitors like Tofacitinib have shown benefits in recalcitrant HS cases when used in conjunction with other therapies. However, specific FDA approvals for JAK inhibitors in HS are still under investigation, with ongoing clinical trials assessing their efficacy and safety.

What other types of research exist?

Promising, novel alternatives to Upadacitinib for Hidradenitis Suppurativa patients include IL-17 inhibitors and targeted biologic therapies. Additionally, combined radical resection with adjuvant biologic therapy is a potential treatment strategy for severe cases.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

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 more

Awards & 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

0 / 3Eligibility criteria met

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.