Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000827-15 | EudraCT Number |
Not provided
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The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | INCB054707 at the Cohort 1 dose or placebo. |
|
| Cohort 2 | Experimental | INCB054707 at the Cohort 2 dose or placebo. |
|
| Cohort 3 | Experimental | INCB054707 at the Cohort 3 dose or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB054707 | Drug | INCB054707 tablet administered orally once daily at the protocol-defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe". | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Oral Clearance of INCB054707 | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 |
| Apparent Oral Volume of Distribution of INCB054707 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Winnipeg | Manitoba | R3M 3Z4 | Canada | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34978076 | Derived | Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6. |
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A total of 43 participants were screened for enrollment in the study, 8 did not meet the eligibility criteria. A total of 35 participants were randomized to one of the treatment groups.
The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was administered QD over an 8 week treatment period. |
| FG001 | INCB054707 at 30 mg | INCB054707 was administered at 30 mg QD over an 8 week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2018 | Aug 12, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo tablet administered orally once daily. |
|
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. |
| Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 |
| Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | HiSCR defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. | Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | AN defined as abscess and inflammatory nodule count. | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine"). | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| Mean Change From Baseline in the Modified Sartorius Scale Score | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS. | From baseline up to week 8 |
| Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. | Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months) |
| Proportion of Participants at Each Category of Hurley Stage | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Baseline and Week 8 |
| Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. | Up to 12 weeks |
| Actual Measurements in HS-PGIC at Each Visit | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. | Up to 12 weeks |
| Proportion of Participants With Change From Baseline Hurley Stage | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Baseline and Week 8 |
| Fredericton |
| New Brunswick |
| E3B 1G9 |
| Canada |
| Investigative Site | Barrie | Ontario | L4M 7G1 | Canada |
| Investigative Site | London | Ontario | N6H 5L5 | Canada |
| Investigative Site 009 | Markham | Ontario | L3P 1X2 | Canada |
| Investigative Site 008 | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Investigative Site 007 | Windsor | Ontario | N8W 5L7 | Canada |
| Investigative Site | Drummondville | Quebec | J2B 5L4 | Canada |
| Investigative Site | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Investigative Site | Aarhus | 8200 | Denmark |
| Investigative Site | Roskilde | 4000 | Denmark |
| Investigative Site | Bochum | Noth Rhine-Westphalia | 44791 | Germany |
| Investigative Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| FG002 | INCB054707 at 60 mg | INCB054707 was administered at 60 mg QD over an 8 week treatment period. |
| FG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was administered QD over an 8 week treatment period. |
| BG001 | INCB054707 at 30 mg | INCB054707 was administered at 30 mg QD over an 8 week treatment period. |
| BG002 | INCB054707 at 60 mg | INCB054707 was administered at 60 mg QD over an 8 week treatment period. |
| BG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week 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 |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Apparent Oral Clearance of INCB054707 | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Mean | Standard Deviation | L/hr | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 |
|
|
| |||||||||||||||||||||||||
| Secondary | Apparent Oral Volume of Distribution of INCB054707 | To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707. | The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707 | Posted | Mean | Standard Deviation | L | Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | HiSCR defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. | Full Analysis Set Population. Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit | Posted | Count of Participants | Participants | Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit | AN defined as abscess and inflammatory nodule count. | Full Analysis Set Population In placebo group 1 participant discontinued the study before week 1, second participant missed all the visits and only had early termination visit. In the 90mg group 1 participant missed week 1 visit and a second participant discontinued before the follow up visit | Posted | Count of Participants | Participants | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| ||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit | An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine"). | Full Analysis Set Population | Posted | Mean | Standard Deviation | Units on a scale | Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months) |
| |||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Modified Sartorius Scale Score | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS. | Full Analysis Set Population | Posted | Mean | Standard Deviation | Units on a scale | From baseline up to week 8 |
| |||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit. | Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. | Full Analysis Set Population | Posted | Mean | Standard Deviation | Number of Fistulas | Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months) |
| |||||||||||||||||||||||||||
| Secondary | Proportion of Participants at Each Category of Hurley Stage | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Full Analysis Set Population | Posted | Count of Participants | Participants | Baseline and Week 8 |
| ||||||||||||||||||||||||||||
| Secondary | Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. | Full Analysis Set Population | Posted | Count of Participants | Participants | Up to 12 weeks |
| ||||||||||||||||||||||||||||
| Secondary | Actual Measurements in HS-PGIC at Each Visit | The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse. | Full Analysis Set Population | Posted | Count of Participants | Participants | Up to 12 weeks |
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Change From Baseline Hurley Stage | The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring). Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. | Full Analysis Set Population | Posted | Count of Participants | Participants | Baseline and Week 8 |
| ||||||||||||||||||||||||||||
| Primary | Number of Treatment-emergent Adverse Events (TEAEs) | TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe". | Full Analysis Set Population | Posted | Count of Participants | Participants | Up to 12 weeks |
|
up to 12 weeks
Not provided
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 | Placebo was administered QD over an 8 week treatment period. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG001 | INCB054707 at 30 mg | INCB054707 was administered at 30 mg QD over an 8 week treatment period. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG002 | INCB054707 at 60 mg | INCB054707 was administered at 60 mg QD over an 8 week treatment period. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week treatment period. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | Total | Total | 0 | 35 | 0 | 35 | 25 | 35 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acne cystic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA 20.0 | Systematic Assessment |
|
Clinical Study Agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2019 | Aug 12, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| Male |
|
| Black/African-American |
|
| American-Indian/Alaska Native |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
|
INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
| OG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
INCB054707 was administered at 60 mg QD over an 8 week treatment period.
| OG003 | INCB054707 at 90 mg | INCB054707 was administered at 90 mg QD over an 8 week treatment period. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
| Title | Measurements |
|---|---|
| Yes |
|
| No |
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Stage II |
|
| Stage III |
|
| No HS |
|
| Title | Measurements |
|---|---|
| Stage I |
|
| Stage II |
|
| Stage III |
|
| No HS |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
|
| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Title | Measurements |
|---|---|
| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
|
| Stage II |
|
| Stage III |
|
| No HS |
|
| Missing |
|