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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001981-13 | EudraCT Number |
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To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB054707 15 mg | Experimental | Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
|
| INCB054707 45 mg | Experimental | Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
|
| INCB054707 75 mg | Experimental | Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks. |
|
| Placebo followed by INCB054707 75 mg | Placebo Comparator | Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB054707 | Drug | Oral; Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | Baseline; Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. | Baseline; Week 16 |
| Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 005 | Hoover | Alabama | 35244 | United States | ||
| Investigative Site 003 |
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.
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A total of 209 participants were enrolled at 36 study centers: 26 in North America and 10 in Europe. Data are reported through the cut-off date of 15 December 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period. |
| FG001 | INCB054707 15 mg | Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 10, 2021 | Dec 14, 2022 |
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Triple
| Placebo | Drug | Oral; Tablet |
|
HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. |
| Baseline; Weeks 2, 4, 6, 8, and 12 |
| Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count. | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| Mean Change From Baseline in AN Count at Weeks 2 to 12 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | Baseline; Weeks 2, 4, 6, 8, and 12 |
| Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Total AN count was assessed throughout the study. | Weeks 2, 4, 6, 8, 12, and 16 |
| Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. 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. | up to Week 16 |
| Gilbert |
| Arizona |
| 85295 |
| United States |
| Investigative Site 011 | Phoenix | Arizona | 85006 | United States |
| Investigative Site 014 | Fountain Valley | California | 92708 | United States |
| Investigative Site 010 | Fremont | California | 94538 | United States |
| Investigative Site 012 | Huntington Beach | California | 92647 | United States |
| Investigative Site 022 | Newbury Park | California | 91320 | United States |
| Investigative Site 009 | Sacramento | California | 95815 | United States |
| Investigative Site 025 | Cromwell | Connecticut | 06416 | United States |
| Investigative Site 015 | Coral Gables | Florida | 33134 | United States |
| Investigative Site 021 | Miami | Florida | 33136 | United States |
| Investigative Site 006 | Tampa | Florida | 33614 | United States |
| Investigative Site 001 | Tampa | Florida | 33624 | United States |
| Investigative Site 016 | Atlanta | Georgia | 30328 | United States |
| Investigative Site 002 | West Lafayette | Indiana | 47906 | United States |
| Investigative Site 027 | Baton Rouge | Louisiana | 70808 | United States |
| Investigative Site 023 | New Orleans | Louisiana | 70112 | United States |
| Investigative Site 013 | Boston | Massachusetts | 02215 | United States |
| Investigative Site 004 | Fort Gratiot | Michigan | 48059 | United States |
| Investigative Site 019 | St Louis | Missouri | 63110 | United States |
| Investigative Site 026 | The Bronx | New York | 10468 | United States |
| Investigative Site 008 | Chapel Hill | North Carolina | 27516 | United States |
| Investigative Site 017 | Winston-Salem | North Carolina | 27157 | United States |
| Investigative Site 007 | Hershey | Pennsylvania | 17033 | United States |
| Investigative Site 018 | Bellaire | Texas | 77401 | United States |
| Investigative Site 101 | Calgary | Alberta | T1Y 0B4 | Canada |
| Investigative Site 102 | Calgary | Alberta | T3A 0B2 | Canada |
| Investigative Site 304 | Nantes | 44093 | France |
| Investigative Site 403 | Berlin | 10117 | Germany |
| Investigative Site 401 | Bochum | 44791 | Germany |
| Investigative Site 405 | Dessau | 06847 | Germany |
| Investigative Site 406 | Dresden | 01307 | Germany |
| Investigative Site 404 | Erlangen | 91054 | Germany |
| Investigative Site 402 | Frankfurt am Main | 60590 | Germany |
| Investigative Site 552 | Rzeszów | 35-055 | Poland |
| Investigative Site 551 | Wroclaw | 50-566 | Poland |
| Investigative Site 553 | Wroclaw | 51-318 | Poland |
| Investigative Site 703 | Granada | 18014 | Spain |
| Investigative Site 702 | Madrid | 28007 | Spain |
| Investigative Site 701 | Valencia | 46940 | Spain |
| FG002 | INCB054707 45 mg | Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
| FG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period. |
| BG001 | INCB054707 15 mg | Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. |
| BG002 | INCB054707 45 mg | Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
| BG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Mean abscess and inflammatory nodule (AN) count | Mean | Standard Deviation | abscesses and inflammatory nodules |
| |||||||||||||||
| Mean International Hidradenitis Suppurativa Severity Score System (IHS4) score | The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Mean abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count | Mean | Standard Deviation | abscesses, INs, and DFs |
|
| 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 | Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | abscesses and inflammatory nodules | Baseline; Week 16 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. | ITT Population. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 16 |
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| Secondary | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. | ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2, 4, 6, 8, and 12 |
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| Secondary | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. | ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
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| Secondary | Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
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| Secondary | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count. | ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | abscesses and inflammatory nodules | Baseline; Weeks 2, 4, 6, 8, and 12 |
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| Secondary | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Total AN count was assessed throughout the study. | ITT Population. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Weeks 2, 4, 6, 8, 12, and 16 |
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| Secondary | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | draining fistulas | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
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| Secondary | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. | ITT Population. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | abscesses, INs, and DFs | Baseline; Weeks 2, 4, 6, 8, 12, and 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. 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. | Safety Population: all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period | Posted | Count of Participants | Participants | up to Week 16 |
|
up to Week 16
Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported for members of the Safety Population (all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period).
Not provided
| 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 oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period. | 0 | 52 | 3 | 52 | 15 | 52 |
| EG001 | INCB054707 15 mg | Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. | 0 | 52 | 2 | 52 | 20 | 52 |
| EG002 | INCB054707 45 mg | Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. | 0 | 50 | 1 | 50 | 17 | 50 |
| EG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. | 0 | 53 | 0 | 53 | 19 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess limb | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
|
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 | Oct 12, 2021 | Dec 14, 2022 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Black/African American |
|
| Asian |
|
| American Indian/Alaska Native |
|
| Captured as Other |
|
| Not Hispanic or Latino |
|
| Unknown |
|
| Captured as Other |
|
| LSM difference |
| -4.4 |
| Standard Error of the Mean |
| 1.25 |
| 2-Sided |
| 95 |
| -6.8 |
| -1.9 |
| Superiority |
| MMRM | 0.0021 | LSM difference | -3.8 | Standard Error of the Mean | 1.22 | 2-Sided | 95 | -6.2 | -1.4 | Superiority |
Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
|
|
|
|
|
|
|
Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
| OG002 | INCB054707 45 mg | Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
| OG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
|
|
|
|
| OG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
| OG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
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| OG003 | INCB054707 75 mg | Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. |
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