Trial Outcomes & Findings for A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa (NCT NCT03569371)
NCT ID: NCT03569371
Last Updated: 2022-09-26
Results Overview
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
COMPLETED
PHASE2
10 participants
Up to approximately 12 weeks.
2022-09-26
Participant Flow
The study was conducted at 4 different sites in US.
A total of 10 participants were assigned to treatment with INCB054707.
Participant milestones
| Measure |
INCB054707
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
INCB054707
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Age, Continuous
|
40.7 Number
STANDARD_DEVIATION 14.43 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
7 Participants
|
SECONDARY outcome
Timeframe: Postdose Day1, week 2 and 6Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
To evaluate the systemic exposure to INCB054707.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Apparent Oral Clearance of INCB054707(CL/F)
|
5.07 L/hr
Geometric Coefficient of Variation 24.3
|
SECONDARY outcome
Timeframe: Postdose Day1, week 2 and 6.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
To evaluate the systemic exposure to INCB054707.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Apparent Oral Volume of Distribution of INCB054707(Vc/F)
|
227 L
Geometric Coefficient of Variation 39.9
|
SECONDARY outcome
Timeframe: Postdose Day1, week 2 and 6.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Absorption Constant of INCB054707 (Ka)
|
0.257 1/hr
Geometric Coefficient of Variation 15.2
|
SECONDARY outcome
Timeframe: Postdose Day1, week 2 and 6.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Apparent Inter-compartmental Clearance(Q/F)
|
16.2 L/hr
Geometric Coefficient of Variation 13.4
|
SECONDARY outcome
Timeframe: Weeks 1,2,4,6,8 and FollowUpPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
An HiSCR is 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 at each visit.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 1
|
1 Participants
|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 2
|
3 Participants
|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 4
|
3 Participants
|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 6
|
2 Participants
|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 8
|
3 Participants
|
|
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Follow Up
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 1,2,4,6,8 and FollowUpPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Baseline
|
0 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 1
|
2 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 2
|
4 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 4
|
4 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 6
|
2 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Week 8
|
3 Participants
|
|
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Follow Up
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 1,2,4,6,8 and FollowUpPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine)
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Week 1
|
-1.5 Units on a Scale
Standard Deviation 1.9
|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Week 2
|
-3.2 Units on a Scale
Standard Deviation 2.9
|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Week 4
|
-2.6 Units on a Scale
Standard Deviation 2.9
|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Week 6
|
-3.2 Units on a Scale
Standard Deviation 3.2
|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Week 8
|
-2.0 Units on a Scale
Standard Deviation 1.8
|
|
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Follow Up
|
-1.8 Units on a Scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Week 8.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.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Mean Change From Baseline in the Modified Sartorius Scale Score
|
-13.6 Units on a Scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Week 6
|
1.9 Number of Fistulas
Standard Deviation 2.9
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Week 1
|
-0.1 Number of Fistulas
Standard Deviation 0.6
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Week 2
|
0.2 Number of Fistulas
Standard Deviation 0.4
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Week 4
|
0.6 Number of Fistulas
Standard Deviation 1.7
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Week 8
|
0.1 Number of Fistulas
Standard Deviation 1.1
|
|
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Follow Up
|
0.7 Number of Fistulas
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
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.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage III
|
1 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage I
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage II
|
7 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · Stage III
|
3 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Baseline · No HS
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage I
|
0 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · Stage II
|
5 Participants
|
|
Proportion of Participants at Each Category of Hurley Stage
Week 8 · No HS
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 8.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
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.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Baseline · No HS
|
0 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Baseline · Stage I
|
0 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Baseline · Stage II
|
7 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Baseline · Stage III
|
3 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Week 8 · No HS
|
1 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Week 8 · Stage I
|
0 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Week 8 · Stage II
|
5 Participants
|
|
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Week 8 · Stage III
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
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.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 1
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 2
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 3
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 4
|
5 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 5
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 1 · 7
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 1
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 2
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 3
|
5 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 4
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 5
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 2 · 7
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 1
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 2
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 3
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 4
|
4 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 5
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 4 · 7
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 1
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 2
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 3
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 4
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 5
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 6 · 7
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 1
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 2
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 3
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 4
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 5
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Week 8 · 7
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 1
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 2
|
1 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 3
|
2 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 4
|
3 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 5
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 6
|
0 Participants
|
|
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Follow Up · 7
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 8 · Intervention Required -No
|
6 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 1 · Intervention Required -Yes
|
1 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 1 · Intervention Required -No
|
9 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 2 · Intervention Required -Yes
|
0 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 2 · Intervention Required -No
|
9 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 4 · Intervention Required -Yes
|
0 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 4 · Intervention Required -No
|
9 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 6 · Intervention Required -Yes
|
0 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 6 · Intervention Required -No
|
7 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Week 8 · Intervention Required -Yes
|
1 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Follow Up · Intervention Required -Yes
|
0 Participants
|
|
Proportion of Participants Requiring Rescue Lesional Treatment
Follow Up · Intervention Required -No
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Number of Interventions With Rescue Lesional Treatment
Week 1
|
0.1 Interventions
Standard Deviation 0.32
|
|
Number of Interventions With Rescue Lesional Treatment
Week 2
|
0 Interventions
Standard Deviation 0.00
|
|
Number of Interventions With Rescue Lesional Treatment
Week 4
|
0 Interventions
Standard Deviation 0.00
|
|
Number of Interventions With Rescue Lesional Treatment
Week 6
|
0 Interventions
Standard Deviation 0.00
|
|
Number of Interventions With Rescue Lesional Treatment
Week 8
|
0.1 Interventions
Standard Deviation 0.38
|
|
Number of Interventions With Rescue Lesional Treatment
Follow Up
|
0 Interventions
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeks.Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCB054707
The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life
Outcome measures
| Measure |
INCB054707
n=10 Participants
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Baseline · 21-30
|
4 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 1 · 0-1
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 1 · 2-5
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 1 · 6-10
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 1 · 11-20
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 1 · 21-30
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 2 · 0-1
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 2 · 2-5
|
5 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 2 · 6-10
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 2 · 11-20
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 2 · 21-30
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 4 · 0-1
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 4 · 2-5
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 4 · 6-10
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 4 · 11-20
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 4 · 21-30
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 6 · 0-1
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 6 · 2-5
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 6 · 6-10
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 6 · 11-20
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 6 · 21-30
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 8 · 0-1
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 8 · 2-5
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 8 · 6-10
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 8 · 11-20
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Week 8 · 21-30
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Follow Up · 0-1
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Follow Up · 2-5
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Follow Up · 6-10
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Follow Up · 11-20
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Follow Up · 21-30
|
2 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Baseline · 0-1
|
0 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Baseline · 2-5
|
1 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Baseline · 6-10
|
3 Participants
|
|
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Baseline · 11-20
|
2 Participants
|
Adverse Events
INCB054707
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
INCB054707
n=10 participants at risk
Participants were treated with 15 mg QD of INCB054707 orally.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Up to approximately 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
3/10 • Up to approximately 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
10.0%
1/10 • Up to approximately 12 weeks
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to approximately 12 weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Up to approximately 12 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Up to approximately 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Up to approximately 12 weeks
|
Additional Information
Incyte Corporation Call Center, Study Director
Incyte Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER