Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05889182
Registration number
NCT05889182
Ethics application status
Date submitted
26/05/2023
Date registered
5/06/2023
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
Query!
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
Query!
Secondary ID [1]
0
0
2023-503661-28-00
Query!
Secondary ID [2]
0
0
M23-698
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Step-Up HS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline to Week 16
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline to Week 16
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS = 3 at Baseline
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline to Week 4
Query!
Secondary outcome [3]
0
0
Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1
Query!
Assessment method [3]
0
0
Defined as at least one occurrence of a = 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.
Query!
Timepoint [3]
0
0
Week 16
Query!
Secondary outcome [4]
0
0
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline to Week 16
Query!
Secondary outcome [5]
0
0
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline to Week 16
Query!
Secondary outcome [6]
0
0
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age =16 Years Old
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline to Week 16
Query!
Secondary outcome [7]
0
0
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline to Week 16
Query!
Secondary outcome [8]
0
0
Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS
Query!
Assessment method [8]
0
0
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
Query!
Timepoint [8]
0
0
At Week 8
Query!
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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/06/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2027
Query!
Actual
Query!
Sample size
Target
1328
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Query!
Recruitment hospital [1]
0
0
Paratus Clinical Research Woden /ID# 254670 - Phillip
Query!
Recruitment hospital [2]
0
0
Holdsworth House Medical Practice /ID# 254411 - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Skin Health Institute Inc /ID# 254416 - Carlton
Query!
Recruitment hospital [4]
0
0
Sinclair Dermatology - Melbourne /ID# 254412 - East Melbourne
Query!
Recruitment hospital [5]
0
0
The Alfred Hospital /ID# 254414 - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nevada
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Ciudad Autonoma De Buenos Aires
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Buenos Aires
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Caba
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Oberoesterreich
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Steiermark
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Wien
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Bruxelles-Capitale
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Hainaut
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Liege
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Oost-Vlaanderen
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Vlaams-Brabant
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Rio De Janeiro
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Rio Grande Do Sul
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Sao Paulo
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Sofiya
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Stara Zagora
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
British Columbia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Manitoba
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Newfoundland and Labrador
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Ontario
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Quebec
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Saskatchewan
Query!
Country [51]
0
0
Chile
Query!
State/province [51]
0
0
Region Metropolitana De Santiago
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Region Metropolitana Santiago
Query!
Country [53]
0
0
Chile
Query!
State/province [53]
0
0
Santiago
Query!
Country [54]
0
0
Colombia
Query!
State/province [54]
0
0
Antioquia
Query!
Country [55]
0
0
Croatia
Query!
State/province [55]
0
0
Grad Zagreb
Query!
Country [56]
0
0
Croatia
Query!
State/province [56]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [57]
0
0
Croatia
Query!
State/province [57]
0
0
Zagrebacka Zupanija
Query!
Country [58]
0
0
Croatia
Query!
State/province [58]
0
0
Rijeka
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Karlovy Vary
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Prague
Query!
Country [61]
0
0
Czechia
Query!
State/province [61]
0
0
Praha
Query!
Country [62]
0
0
Finland
Query!
State/province [62]
0
0
Etela-Pohjanmaa
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Alpes-Maritimes
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Gironde
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Ile-de-France
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Marne
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Pays-de-la-Loire
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Rhone
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Niedersachsen
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Berlin
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Bochum
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Magdeburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Mainz
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Munich
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Regensburg
Query!
Country [76]
0
0
Greece
Query!
State/province [76]
0
0
Attiki
Query!
Country [77]
0
0
Greece
Query!
State/province [77]
0
0
Evrytania
Query!
Country [78]
0
0
Hungary
Query!
State/province [78]
0
0
Hajdu-Bihar
Query!
Country [79]
0
0
Hungary
Query!
State/province [79]
0
0
Nograd
Query!
Country [80]
0
0
Hungary
Query!
State/province [80]
0
0
Somogy
Query!
Country [81]
0
0
Hungary
Query!
State/province [81]
0
0
Vas
Query!
Country [82]
0
0
Hungary
Query!
State/province [82]
0
0
Budapest
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Debrecen
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Szeged
Query!
Country [85]
0
0
Ireland
Query!
State/province [85]
0
0
Dublin
Query!
Country [86]
0
0
Ireland
Query!
State/province [86]
0
0
Cork
Query!
Country [87]
0
0
Ireland
Query!
State/province [87]
0
0
Galway
Query!
Country [88]
0
0
Ireland
Query!
State/province [88]
0
0
Waterford
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
H_efa
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
HaTsafon
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Tel-Aviv
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Haifa
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Ferrara
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Roma
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Brescia
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Florence
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Milan
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Modena
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Pisa
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Fukuoka
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Hyogo
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Ibaraki
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kyoto
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Miyagi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Okinawa
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Osaka
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Shiga
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Tokyo
Query!
Country [109]
0
0
Korea, Republic of
Query!
State/province [109]
0
0
Gyeonggido
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Seoul Teugbyeolsi
Query!
Country [111]
0
0
Lithuania
Query!
State/province [111]
0
0
Kazlu Rudos
Query!
Country [112]
0
0
Netherlands
Query!
State/province [112]
0
0
Noord-Brabant
Query!
Country [113]
0
0
Netherlands
Query!
State/province [113]
0
0
Groningen
Query!
Country [114]
0
0
New Zealand
Query!
State/province [114]
0
0
Auckland
Query!
Country [115]
0
0
New Zealand
Query!
State/province [115]
0
0
Manawatu-Wanganui
Query!
Country [116]
0
0
Portugal
Query!
State/province [116]
0
0
Regiao Autonoma Da Madeira
Query!
Country [117]
0
0
Portugal
Query!
State/province [117]
0
0
Lisbon
Query!
Country [118]
0
0
Portugal
Query!
State/province [118]
0
0
Porto
Query!
Country [119]
0
0
Puerto Rico
Query!
State/province [119]
0
0
Caguas
Query!
Country [120]
0
0
Puerto Rico
Query!
State/province [120]
0
0
Carolina
Query!
Country [121]
0
0
Saudi Arabia
Query!
State/province [121]
0
0
Ar Riyad
Query!
Country [122]
0
0
Saudi Arabia
Query!
State/province [122]
0
0
Makkah
Query!
Country [123]
0
0
Saudi Arabia
Query!
State/province [123]
0
0
Riyadh
Query!
Country [124]
0
0
Singapore
Query!
State/province [124]
0
0
Central Singapore
Query!
Country [125]
0
0
Singapore
Query!
State/province [125]
0
0
Singapore
Query!
Country [126]
0
0
Slovakia
Query!
State/province [126]
0
0
Bratislavsky Kraj
Query!
Country [127]
0
0
Slovakia
Query!
State/province [127]
0
0
Kosicky Kraj
Query!
Country [128]
0
0
Slovakia
Query!
State/province [128]
0
0
Zilinsky Kraj
Query!
Country [129]
0
0
Slovakia
Query!
State/province [129]
0
0
Trnava
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Barcelona
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Madrid
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Valencia
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Granada
Query!
Country [134]
0
0
Sweden
Query!
State/province [134]
0
0
Stockholms Lan
Query!
Country [135]
0
0
Sweden
Query!
State/province [135]
0
0
Vastra Gotalands Lan
Query!
Country [136]
0
0
Switzerland
Query!
State/province [136]
0
0
Sankt Gallen
Query!
Country [137]
0
0
Switzerland
Query!
State/province [137]
0
0
Zuerich
Query!
Country [138]
0
0
Switzerland
Query!
State/province [138]
0
0
Bern
Query!
Country [139]
0
0
Taiwan
Query!
State/province [139]
0
0
Kaohsiung
Query!
Country [140]
0
0
Taiwan
Query!
State/province [140]
0
0
Taipei
Query!
Country [141]
0
0
Taiwan
Query!
State/province [141]
0
0
Changhua City, Changhua County
Query!
Country [142]
0
0
Taiwan
Query!
State/province [142]
0
0
Taoyuan City
Query!
Country [143]
0
0
Turkey
Query!
State/province [143]
0
0
Adana
Query!
Country [144]
0
0
Turkey
Query!
State/province [144]
0
0
Bursa
Query!
Country [145]
0
0
Turkey
Query!
State/province [145]
0
0
Kayseri
Query!
Country [146]
0
0
Turkey
Query!
State/province [146]
0
0
Samsun
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
Bolton
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Hampshire
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Leeds
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
London
Query!
Country [151]
0
0
United Kingdom
Query!
State/province [151]
0
0
Salford
Query!
Country [152]
0
0
United Kingdom
Query!
State/province [152]
0
0
Tooting
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05889182
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05889182