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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
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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
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Secondary ID [1]
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2023-503661-28-00
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Secondary ID [2]
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M23-698
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Universal Trial Number (UTN)
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Trial acronym
Step-Up HS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 16
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Secondary outcome [1]
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Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS = 3 at Baseline
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline to Week 4
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Secondary outcome [3]
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Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1
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Assessment method [3]
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Defined as at least one occurrence of a = 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Week 16
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Secondary outcome [5]
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Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to Week 16
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Secondary outcome [6]
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Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age =16 Years Old
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to Week 16
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Secondary outcome [7]
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Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline to Week 16
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Secondary outcome [8]
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Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS
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Assessment method [8]
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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
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Timepoint [8]
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At Week 8
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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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2027
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Actual
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Sample size
Target
1328
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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Paratus Clinical Research Woden /ID# 254670 - Phillip
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Recruitment hospital [2]
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Holdsworth House Medical Practice /ID# 254411 - Darlinghurst
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Recruitment hospital [3]
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Skin Health Institute Inc /ID# 254416 - Carlton
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Sinclair Dermatology - Melbourne /ID# 254412 - East Melbourne
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Recruitment hospital [5]
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The Alfred Hospital /ID# 254414 - Melbourne
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
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Tokyo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul
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Lithuania
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Vilnius
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Netherlands
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Noord-Brabant
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Groningen
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Caguas
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Carolina
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Saudi Arabia
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State/province [115]
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Ar Riyad
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Saudi Arabia
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Makkah
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Saudi Arabia
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Riyadh
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Singapore
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Central Singapore
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Singapore
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Singapore
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Slovakia
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Bratislavsky Kraj
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Slovakia
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Zilinsky Kraj
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Trnava
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Valencia
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Granada
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Sankt Gallen
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Zuerich
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Bern
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Taiwan
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Changhua City, Changhua County
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Taiwan
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Taoyuan City
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Turkey
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Bursa
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Turkey
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Samsun
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United Kingdom
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Hampshire
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Salford
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United Kingdom
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05889182
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05889182
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