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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05889182




Registration number
NCT05889182
Ethics application status
Date submitted
26/05/2023
Date registered
5/06/2023
Date last updated
7/06/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2023-503661-28-00
Secondary ID [2] 0 0
M23-698
Universal Trial Number (UTN)
Trial acronym
Step-Up HS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo

Experimental: Period 1: Upadacitinib Dose A - Participants will receive Upadicitinib Dose A once daily for 16 weeks.

Placebo Comparator: Period 1: Placebo - Participants will receive Placebo once daily for 16 weeks.

Experimental: Period 2: Group 1 - Upadacitinib Dose A - 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.

Placebo Comparator: Period 2: Group 2 - Placebo - 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.

Experimental: Period 2: Group 3 - Upadacitinib Dose A - 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.

Experimental: Period 2: Group 4 - Upadacitinib Dose A - 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.

Experimental: Period 2: Group 5 - Upadacitinib Dose B - 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.

Experimental: Period 2: Group 6 - Placebo - 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.

Experimental: Period 3: Long-Term Extension - Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.


Treatment: Drugs: Upadacitinib
Oral Tablets

Treatment: Drugs: Placebo
Oral Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS = 3 at Baseline
Timepoint [2] 0 0
Baseline to Week 4
Secondary outcome [3] 0 0
Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
Timepoint [4] 0 0
Baseline to Week 16
Secondary outcome [5] 0 0
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Timepoint [5] 0 0
Baseline to Week 16
Secondary outcome [6] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age =16 Years Old
Timepoint [6] 0 0
Baseline to Week 16
Secondary outcome [7] 0 0
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
Timepoint [7] 0 0
Baseline to Week 16
Secondary outcome [8] 0 0
Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS
Timepoint [8] 0 0
At Week 8

Eligibility
Key inclusion criteria
- Diagnosis of HS for at least 6 months prior to Baseline, as determined by the
investigator (i.e., through medical history and interview of subject).

- Documented history of previous use of = 1 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 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
1328
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden /ID# 254670 - Phillip
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice /ID# 254411 - Darlinghurst
Recruitment hospital [3] 0 0
Skin Health Institute Inc /ID# 254416 - Carlton
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne /ID# 254412 - East Melbourne
Recruitment hospital [5] 0 0
The Alfred Hospital /ID# 254414 - Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
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Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 275 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05889182
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05889182