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Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.
Upadacitinib is an investigational drug being developed for the treatment of HS. This study is "double-blinded," which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly (by chance) put into 1 of 2 groups, called treatment arms. They are randomized in a 2 to 1 ratio meaning more participants have a chance to receive upadacitinib compared to placebo.
Participants will undergo approximately 35-days of screening followed by a 48-week treatment period and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks. The treatment period will consist of a 12-week placebo-controlled, double-blind period (Period 1) and a 36-week blinded extension period (Period 2).
There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend visits every other week, once a month, or once every 2 months during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib 30 mg | Experimental | Participants will receive 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2). |
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| Placebo followed by Upadacitinib 15 mg | Experimental | Participants will receive matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Tablet; Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3 | The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period). NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3. |
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Inclusion Criteria:
Exclusion Criteria:
-History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialist /ID# 221084 | Phoenix | Arizona | 85006-2722 | United States | ||
| University of Arkansas for Medical Sciences /ID# 218404 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39909350 | Derived | Ackerman LS, Schlosser BJ, Zhan T, Prajapati VH, Fretzin S, Takahashi H, Huang X, Camp HS, Kimball AB. Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study. J Am Acad Dermatol. 2025 Jun;92(6):1252-1260. doi: 10.1016/j.jaad.2024.12.046. Epub 2025 Feb 4. |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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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, analyses plans, 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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Participants were randomized to upadacitinib or placebo in a 2:1 ratio. Randomization was stratified by anti-tumor necrosis factor (TNF) use prior to Baseline (yes or no) and Hurley stage (< III or III).
Participants were enrolled at 21 study sites in 3 countries (Canada, Japan, and United States/Puerto Rico).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / Upadacitinib 15 mg | Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2). |
| FG001 | Upadacitinib 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Weeks 1-12) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2020 | Jan 10, 2023 |
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| Placebo | Drug | Tablet; Oral |
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| Baseline and Week 12 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Medderm Associates /ID# 218317 | San Diego | California | 92103 | United States |
| Skin Care Research - Boca Raton /ID# 218809 | Boca Raton | Florida | 33486-2269 | United States |
| Lakes Research, LLC /ID# 218854 | Miami | Florida | 33014 | United States |
| ForCare Clinical Research /ID# 218013 | Tampa | Florida | 33613-1244 | United States |
| Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319 | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin, LLC /ID# 218310 | Indianapolis | Indiana | 46256 | United States |
| Beth Israel Deaconess Medical Center /ID# 218306 | Boston | Massachusetts | 02215-5400 | United States |
| Washington University-School of Medicine /ID# 218331 | St Louis | Missouri | 63110 | United States |
| Psoriasis Treatment Center of Central New Jersey /ID# 218330 | East Windsor | New Jersey | 08520 | United States |
| Duke Cancer Center /ID# 218526 | Durham | North Carolina | 27710-3000 | United States |
| University Hospitals Case Medical Center /ID# 218326 | Cleveland | Ohio | 44106 | United States |
| Southside Dermatology /ID# 218321 | Tulsa | Oklahoma | 74132 | United States |
| University of Pittsburgh MC /ID# 218329 | Pittsburgh | Pennsylvania | 15260 | United States |
| Medical University of South Carolina /ID# 218318 | Charleston | South Carolina | 29425 | United States |
| Duplicate_Center for Clinical Studies /ID# 218307 | Houston | Texas | 77004 | United States |
| Dermatology Specialists of Spokane /ID# 218760 | Spokane | Washington | 99202 | United States |
| Dermatology Research Institute Inc. /ID# 218780 | Calgary | Alberta | T2J 7E1 | Canada |
| Winnipeg Clinic /ID# 218963 | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Dr. Wei Jing Loo Medicine Prof /ID# 218779 | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc. /ID# 218778 | Markham | Ontario | L3P 1X2 | Canada |
| Takagi Dermatology Clinic /ID# 218587 | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 220859 | Kyoto | Kyoto | 602-8566 | Japan |
| Toranomon Hospital /ID# 218588 | Minato-ku | Tokyo | 105-8470 | Japan |
| Cruz-Santana, Carolina, PR /ID# 221188 | Carolina | 00985 | Puerto Rico |
Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
| Received Study Drug |
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| Period 2 (Weeks 12-48) |
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The Intent-to-treat (ITT) population includes all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo / Upadacitinib 15 mg | Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2). |
| BG001 | Upadacitinib 30 mg | Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Prior Exposure to Tumor Necrosis Factor (TNF) Antagonists | Count of Participants | Participants |
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| Hurley Stage | The Hurley staging system is a grading system to characterize the extent of disease in patients with hidradenitis suppurativa. Hurley stages are described as follows:
| Count of Participants | Participants |
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| Duration of Hidradenitis Suppurativa (HS) Disease | Mean | Standard Deviation | years |
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| Abscess Lesion Count | Abscesses are lesions that contain fluid, are tender or painful, with or without drainage. | Mean | Standard Deviation | abscess lesions |
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| Inflammatory Nodule Lesion Count | Tender, small lumps under the skin that are inflamed or reddened, | Mean | Standard Deviation | nodule lesions |
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| Draining Fistula Lesion Count | Horizontal channels (or tunnels) below the skin that connect the lesions and open into a sore on the skin surface that releases fluid (pus). | Mean | Standard Deviation | draining fistula lesions |
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| Abscess and Inflammatory Nodule (AN) Count | Mean | Standard Deviation | abscesses and inflammatory nodules |
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| Patient's Global Assessment (PGA) of Skin Pain Score | Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale (NRS) ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. Baseline PGA skin pain score is defined as the last non-missing weekly average score, calculated based on the daily scores from the past 7 days (with non-missing values in 4 or more days of the 7 day period), before the date of the first administration of study drug. | Participants with available data | Mean | Standard Deviation | units on a scale |
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| PGA Skin Pain Score In Participants with a Baseline Value ≥ 3 | Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. Baseline PGA skin pain score is defined as the last non-missing weekly average score, calculated based on the daily scores from the past 7 days (with non-missing values in 4 or more days of the 7 day period), before the date of the first administration of study drug. | Participants with a Baseline PGA skin pain score ≥ 3 | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | HiSCR 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. | Intent-to-treat population; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than coronavirus disease 2019 (COVID-19), and participants who initiated antibiotics for HS-related infections prior to Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3 | The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period). NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3. | Intent-to-treat population with Baseline skin pain NRS ≥ 3; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than COVID-19, and participants who initiated antibiotics for HS-related infections prior to Week 12 and under the impact of analgesic use at Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
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Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Placebo | Participants received matching placebo orally once a day for 12 weeks in Period 1. | 0 | 21 | 0 | 21 | 6 | 21 |
| EG001 | Period 1: Upadacitinib 30 mg | Participants received 30 mg upadacitinib orally once a day for 12 weeks in Period 1. | 0 | 47 | 3 | 47 | 12 | 47 |
| EG002 | Period 2: Upadacitinib 15 mg | Participants originally assigned to placebo received 15 mg upadacitinib orally once a day for 36 weeks in Period 2. | 0 | 19 | 0 | 19 | 10 | 19 |
| EG003 | Period 2: Upadacitinib 30 mg | Participants originally assigned to upadacitinib 30 mg continued to receive 30 mg upadacitinib orally once a day for 36 weeks in Period 2. | 0 | 41 | 5 | 41 | 12 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| ADJUSTMENT DISORDER | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| SUICIDAL BEHAVIOUR | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| SKIN PLAQUE | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 24.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 24.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| ABNORMAL DREAMS | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| HIDRADENITIS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| PERIORAL DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| PRURITUS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2021 | Jan 10, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
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| Lack of Efficacy |
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| As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%. | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No]) | 0.142 | Adjusted Response Rate Difference | 9.2 | 2-Sided | 95 | -7.6 | 25.9 | Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic) | Superiority |
| As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants. | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage [Stage < III, Stage III] and prior TNF use [Yes or No]) | 0.087 | Adjusted Response Rate Difference | 14.7 | 2-Sided | 95 | -6.6 | 36.0 | Response rate difference = upadacitinib 30 mg - placebo | Superiority |
| Upadacitinib 30 mg |
Participants received 30 mg upadacitinib orally once a day for 12 weeks. |
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