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~386 spots leftby Feb 2026

Upadacitinib for Hidradenitis Suppurativa
(Step-Up HS Trial)

Recruiting in Palo Alto (17 mi)

+317 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

Must be taking: Anti-TNF biologics

Must not be taking: Cell-depleting therapies

Disqualifiers: Active skin disease, Investigational drugs, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting. You must stop using prescription topical therapies for HS and systemic antibiotics at least 14 days before the trial begins. Other investigational drugs and certain cell-depleting therapies must also be stopped before participating.

How is the drug Upadacitinib unique for treating hidradenitis suppurativa?

Upadacitinib is unique because it is a selective Janus kinase (JAK)1 inhibitor, which targets specific pathways involved in inflammation, offering a novel approach for treating hidradenitis suppurativa, especially in cases resistant to conventional therapies.¹ ² ³ ⁴ ⁵

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

My skin condition affects at least one area and is moderate to severe.

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 have HS lesions in at least two different body areas.

See 3 more

Exclusion Criteria

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.

See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive oral tablets of upadacitinib or placebo once daily

16 weeks

Regular outpatient visits

Treatment Period 2

Participants continue treatment based on response in Period 1

20 weeks

Regular outpatient visits

Long-Term Extension

Eligible participants continue to receive upadacitinib or placebo

68 weeks

Regular outpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Upadacitinib is already approved in Canada for the following indications:

Approved in Canada as Rinvoq for:

Rheumatoid arthritis
Psoriatic arthritis
Atopic dermatitis
Ankylosing spondylitis

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Research Toronto /ID# 255273Toronto, Canada

UMass Memorial Medical Center /ID# 258839Worcester, MA

Skin Care Research Boca Raton /ID# 253814Boca Raton, FL

Karma Clinical Trials /ID# 254120St. John's, Canada

More Trial Locations

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Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1079

Patients Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Use of Janus Kinase Inhibitors in Inflammatory Cutaneous Diseases.Agarwal, A., Diaz, A., Al-Dehneem, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors.Haslund, P., Lee, RA., Jemec, GB.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects With Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis, or Atopic Dermatitis: Population Analyses of Phase 1 and 2 Clinical Trials.Nader, A., Stodtmann, S., Friedel, A., et al.[2021]

Adalimumab, a treatment for Crohn's disease, has recently been approved for hidradenitis suppurativa, but in this case, it paradoxically triggered the onset of hidradenitis suppurativa in a 40-year-old woman.

This case highlights the potential for unexpected side effects of medications, even those that are effective for other conditions, emphasizing the need for careful monitoring in patients receiving adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox?Martina, E., Campanati, A., Giuliodori, K., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Single Nucleotide Polymorphisms of the Promoter of the TNF Gene on Adalimumab Treatment Responses in Hidradenitis Suppurativa.Argyropoulou, M., Trigoni, A., Kaffenberger, J., et al.[2023]