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The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB054707 Dose A followed by Dose C | Experimental | Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). |
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| INCB054707 Dose B | Experimental | Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2). |
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| INCB054707 Dose C | Experimental | Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2). |
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| Placebo followed by INCB054707 Dose C | Placebo Comparator | Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB054707 | Drug | INCB054707 will be administered once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100. | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving T-VASI50 at Week 24 | T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 010 | Hoover | Alabama | 35244 | United States | ||
| Investigative Site 015 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40518122 | Derived | Pandya AG, Ezzedine K, Passeron T, van Geel N, Brown K, Santos LL, Erskine L, Wagya K, Blauvelt A. Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib in patients with extensive vitiligo in a phase 2, randomized, double-blinded, dose-ranging, placebo-controlled study. J Am Acad Dermatol. 2025 Oct;93(4):946-955. doi: 10.1016/j.jaad.2025.06.027. Epub 2025 Jun 13. |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted in 28 sites in Canada and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). |
| FG001 | Povorcitinib 15 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24-Week Placebo-controlled Period |
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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 | Jul 12, 2022 | May 22, 2023 |
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Double blinded
| Placebo | Drug | Placebo or INCB054707 will be administered once daily |
|
| Baseline; Week 24 |
| Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period. | up to Week 24 |
| Extension Period: Number of Participants With Any TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period. | from Week 25 up to Week 76 |
| Gilbert |
| Arizona |
| 85295 |
| United States |
| Investigative Site 028 | Scottsdale | Arizona | 85260 | United States |
| Investigative Site 006 | Irvine | California | 92697 | United States |
| Investigative Site 009 | Los Angeles | California | 90036 | United States |
| Investigative Site 018 | Los Angeles | California | 90045 | United States |
| Investigative Site 017 | Sacramento | California | 95815 | United States |
| Investigative Site 032 | Orange Park | Florida | 32073 | United States |
| Investigative Site 005 | Tampa | Florida | 33613 | United States |
| Investigative Site 022 | Tampa | Florida | 33614 | United States |
| Investigative Site 011 | West Palm Beach | Florida | 33401 | United States |
| Investigative Site 024 | Covington | Louisiana | 70433 | United States |
| Investigative Site 002 | Brighton | Massachusetts | 02135 | United States |
| Investigative Site 023 | Saint Paul | Minnesota | 55112 | United States |
| Investigative Site 027 | Verona | New Jersey | 07044 | United States |
| Investigative Site 003 | Columbus | Ohio | 43215 | United States |
| Investigative Site 007 | Norman | Oklahoma | 73071 | United States |
| Investigative Site 001 | Portland | Oregon | 97223 | United States |
| Investigative Site 021 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Investigative Site 004 | Murfreesboro | Tennessee | 37130 | United States |
| Investigative Site 033 | Dallas | Texas | 75230 | United States |
| Investigative Site 012 | San Antonio | Texas | 78213 | United States |
| Investigative Site 030 | Spokane | Washington | 99202 | United States |
| Investigative Site 020 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigative Site 014 | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Investigative Site 034 | London | Ontario | N6H 5LR | Canada |
| Investigative Site 025 | Mississauga | Ontario | L5H 1G9 | Canada |
| Investigative Site 026 | North YORK | Ontario | M2M4J5 | Canada |
| Investigative Site 031 | Oakville | Ontario | L6J 7W5 | Canada |
| Investigative Site 008 | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigative Site 029 | Québec | Quebec | Q1V 4X7 | Canada |
Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period). |
| FG002 | Povorcitinib 45 mg | Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). |
| FG003 | Povorcitinib 75 mg | Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period. |
| COMPLETED |
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| NOT COMPLETED |
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| 28-Week Double-blind Extension Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). |
| BG001 | Povorcitinib 15 mg | Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period). |
| BG002 | Povorcitinib 45 mg | Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). |
| BG003 | Povorcitinib 75 mg | Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period. |
| BG004 | 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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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Total Vitiligo Area Scoring Index (T-VASI) | The T-VASI was calculated based on values from 6 body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. | Mean | Standard Deviation | scores 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100. | Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Mixed-effect model for repeated measures (MMRM) model: (percent change from Baseline = treatment + stratification factor [T-BSA involvement 8%-20%/>20%] + visit + treatment*visit + Baseline measurement + Baseline measurement*visit). Only participants with available data were analyzed. | Posted | Geometric Least Squares Mean | Standard Error | percent change | Baseline; Week 24 |
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| Secondary | Percentage of Participants Achieving T-VASI50 at Week 24 | T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. | Intent-to-Treat Population. The 95% confidence interval was based on the Clopper-Pearson exact method. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 24 |
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| Secondary | Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period. | Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were to have been determined according to the actual treatment the participant received on Day 1. | Posted | Count of Participants | Participants | up to Week 24 |
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| Secondary | Extension Period: Number of Participants With Any TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period. | Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the double-blind extension period | Posted | Count of Participants | Participants | from Week 25 up to Week 76 |
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up to Week 76
Treatment-emergent adverse events (TEAEs) occurring in the placebo-controlled period have been reported for members of the Safety Population (all participants who received at least 1 dose of povorcitinib or placebo during the placebo-controlled period). TEAEs occurring in the double-blind extension period have been reported for members of the Extension Evaluable Population (participants who received at least 1 dose of povorcitinib during the double-blind extension period).
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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 | Placebo | Participants received matching placebo QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). | 0 | 42 | 1 | 42 | 19 | 42 |
| EG001 | Povorcitinib 15 mg | Participants received oral povorcitinib 15 milligrams (mg) once daily (QD) for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for 28 weeks (double-blind extension period). | 0 | 43 | 0 | 43 | 22 | 43 |
| EG002 | Povorcitinib 45 mg | Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). | 0 | 41 | 1 | 41 | 24 | 41 |
| EG003 | Povorcitinib 75 mg | Participants received placebo, oral povorcitinib 15 mg QD, or oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). | 0 | 114 | 1 | 114 | 69 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 26 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
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Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2022 | May 22, 2023 | SAP_001.pdf |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Non-compliance |
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| Non-compliance with Study Drug |
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| Scheduling Conflicts |
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| Male |
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| Black/African-American |
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| Asian |
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| Mexican American |
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| African-European |
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| Middle Eastern |
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| Columbian |
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| Captured as Hispanic in Database |
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| Mixed |
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| Mexican |
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| East Indian |
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| Did Not Identify with Options Provided |
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| White and Asian-Non-Japanese |
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| South African |
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| White/Black |
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| South American |
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| Egyptian |
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| Captured as Hispanic/Latino in Database |
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| Not Hispanic or Latino |
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| Not Reported |
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| Bangladeshi |
|
| 0.0040 |
| Least squares mean difference |
| -20.07 |
| Standard Error of the Mean |
| 6.86 |
| 2-Sided |
| 95 |
| -33.63 |
| -6.51 |
| Superiority |
| MMRM | 0.0086 | Least squares mean difference | -18.02 | Standard Error of the Mean | 6.77 | 2-Sided | 95 | -31.40 | -4.64 | Superiority |
| OG002 | Povorcitinib 45 mg | Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). |
| OG003 | Povorcitinib 75 mg | Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). |
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|
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| OG002 | Povorcitinib 45 mg | Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). |
| OG003 | Povorcitinib 75 mg | Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). |
|
|
| Povorcitinib 45 mg |
Participants received oral povorcitinib 45 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 45 mg QD for an additional 28 weeks (double-blind extension period). |
| OG003 | Povorcitinib 75 mg | Participants received oral povorcitinib 75 mg QD for 24 weeks (placebo-controlled period). Participants who completed the Week 24 visit received oral povorcitinib 75 mg QD for an additional 28 weeks (double-blind extension period). |
|
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