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[M23-698] 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

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

Yamazaki Hayato

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

June. 27, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Minimum Age:12 Years
-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 or higher 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 or higher 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 or lower 20 at Baseline.

-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.

Both

Hidradenitis Suppurativa

Oral tablet.

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 16weeks.

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.

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
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.
[Time Frame: Baseline to Week 16]

-Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75.
HiSCR 75 is defined as at least a 75 percent 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.
[Time Frame: Baseline to Week 16]

-Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Subjects with NRS or higher 3 at Baseline.
Achievement will be considered at least a 30 percent reduction and at least 2 units reduction from Baseline in NRS scale in the Patient's Global Assessment (PGA) of HS-related skin pain 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).
[Time Frame: Baseline to Week 4]

-Incidence of Hidradenitis Suppurativa (HS) Flare During Period 1.
Defined as at least one occurrence of a or higher 25percent increase in AN count, with a minimum absolute increase of 2 relative to Baseline.
[Time Frame: Week 16]

-Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA).
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.
[Time Frame: Baseline to Week 16]

-Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA).
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.
[Time Frame: Baseline to Week 16]

-Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Subjects and Adolescent Subjects Age 17 Years Old or Children's DLQI (CDLQI) for Adolescent Subjects Ages 12 to 16 Years Old.
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 equal not at all/not relevant; 1 equal a little; 2 equal a lot; and 3 equal very much.
[Time Frame: Baseline to Week 16]

-Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8.
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.
[Time Frame: Baseline to Week 16]

June. 19, 2023

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic 3 / 3 Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinicaltrials/clinical-trials-data-and-information-sharing.html

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