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NCT Number: NCT05889182

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide.

Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Austral /ID# 254904, Pilar, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant).
  • Documented history of previous use of >= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
  • Participant must have a total abscess and inflammatory nodule (AN) count of >= 5 at Baseline.
  • HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
  • At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
  • Draining fistula count of <= 20 at Baseline.

Exclusion criteria

  • History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
  • Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
  • 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.
  • Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
  • Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.

Treatment and study plan

Upadacitinib

Drug

Oral Tablets

Other names: ABT-494, RINVOQ

Placebo

Drug

Oral Tablets

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50

    Time frame: Baseline to Week 16

    HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately Week 108

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Change from Baseline in Draining Fistula Count

    Time frame: Baseline to Week 16

    Change from baseline in draining fistula count.

  2. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75

    Time frame: Baseline to Week 16

    HiSCR 75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

  3. Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline

    Time frame: Baseline to Week 4

    Achievement will be considered at least a 30% reduction and at least 2 units reduction from Baseline in the Participant's Global Assessment (PGA) of HS-related skin pain NRS based on worst skin pain in a 24-hour recall period (maximal daily pain). The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).

  4. Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)

    Time frame: Baseline to Week 16

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

  5. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)

    Time frame: Baseline to Week 16

    The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.

  6. Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older

    Time frame: Baseline to Week 16

    The DLQI and the CDLQI are both 10-item questionnaires used to assess the impact of hidradenitis suppurativa (HS) disease symptoms and treatment on quality of life that consists of 10 questions scored on a 4-point scale where 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much.

  7. Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8

    Time frame: Baseline to Week 16

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

  8. Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS

    Time frame: Baseline to Week 8

    The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) that is used to assess the worst pain due to HS. Patients are asked to respond to the item based on a recall period of "the last 24 hours

  9. Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1

    Time frame: Baseline to Week 16

    Defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Acronym: Step-Up HS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2023
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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