Acne Inversa, Hidradenitis Suppurativa
Conditions
Brief summary
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).
Interventions
DRUGINCB054707
Oral; Tablet
DRUGPlacebo
Oral; Tablet
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HS disease duration of at least 3 months before screening. * Willingness to avoid pregnancy or fathering children. * Active HS in at least 2 distinct anatomical areas. * Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period
Exclusion criteria
* Draining fistula count of \> 20 at screening or baseline. * Women who are pregnant (or who are considering pregnancy) or lactating. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * History of failure to treatment of inflammatory diseases with JAK inhibitors. * Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. * Participants known to be infected with HIV, Hepatitis B, or Hepatitis C. * Laboratory values outside of the protocol-defined ranges.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline; 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Baseline; Weeks 2, 4, 6, 8, and 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. |
| Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Baseline; Weeks 2, 4, 6, 8, 12, and 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. |
| 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 | Baseline; Weeks 2, 4, 6, 8, 12, and 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. |
| Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | Baseline; Weeks 2, 4, 6, 8, 12, and 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count. |
| Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | Baseline; 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. |
| Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Weeks 2, 4, 6, 8, 12, and 16 | Total AN count was assessed throughout the study. |
| Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Baseline; Weeks 2, 4, 6, 8, 12, and 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Baseline; Weeks 2, 4, 6, 8, 12, and 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. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | up to Week 16 | 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. |
| Mean Change From Baseline in AN Count at Weeks 2 to 12 | Baseline; Weeks 2, 4, 6, 8, and 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. |
Countries
Canada, France, Germany, Poland, Spain, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received oral placebo once a day (QD) for 16 weeks in the Placebo-controlled Treatment Period. | 52 |
| INCB054707 15 mg Participants received oral INCB054707 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. | 52 |
| INCB054707 45 mg Participants received oral INCB054707 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. | 52 |
| INCB054707 75 mg Participants received oral INCB054707 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. | 53 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 4 | 1 |
Baseline characteristics
| Characteristic | INCB054707 15 mg | INCB054707 45 mg | Placebo | INCB054707 75 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 10.85 | 37.3 years STANDARD_DEVIATION 12.51 | 35.2 years STANDARD_DEVIATION 9.96 | 37.5 years STANDARD_DEVIATION 10.83 | 37.1 years STANDARD_DEVIATION 11.05 |
| Mean abscess and inflammatory nodule (AN) count | 11.8 abscesses and inflammatory nodules STANDARD_DEVIATION 7.1 | 12.9 abscesses and inflammatory nodules STANDARD_DEVIATION 12.34 | 11.2 abscesses and inflammatory nodules STANDARD_DEVIATION 5.85 | 10.6 abscesses and inflammatory nodules STANDARD_DEVIATION 7.24 | 11.6 abscesses and inflammatory nodules STANDARD_DEVIATION 8.48 |
| Mean abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count | 14.1 abscesses, INs, and DFs STANDARD_DEVIATION 10.08 | 15.1 abscesses, INs, and DFs STANDARD_DEVIATION 13.51 | 13.6 abscesses, INs, and DFs STANDARD_DEVIATION 6.36 | 12.2 abscesses, INs, and DFs STANDARD_DEVIATION 8.94 | 13.7 abscesses, INs, and DFs STANDARD_DEVIATION 10.03 |
| Mean International Hidradenitis Suppurativa Severity Score System (IHS4) score | 22.4 scores on a scale STANDARD_DEVIATION 23.24 | 23.5 scores on a scale STANDARD_DEVIATION 22.79 | 22.9 scores on a scale STANDARD_DEVIATION 17.02 | 18.9 scores on a scale STANDARD_DEVIATION 17.25 | 21.9 scores on a scale STANDARD_DEVIATION 20.21 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Black/African American | 13 Participants | 12 Participants | 10 Participants | 16 Participants | 51 Participants |
| Race/Ethnicity, Customized Captured as Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 7 Participants | 10 Participants | 6 Participants | 28 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 47 Participants | 44 Participants | 41 Participants | 47 Participants | 179 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 36 Participants | 35 Participants | 40 Participants | 36 Participants | 147 Participants |
| Sex: Female, Male Female | 37 Participants | 39 Participants | 43 Participants | 39 Participants | 158 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 9 Participants | 14 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 | 0 / 50 | 0 / 53 |
| other Total, other adverse events | 15 / 52 | 20 / 52 | 17 / 50 | 19 / 53 |
| serious Total, serious adverse events | 3 / 52 | 2 / 52 | 1 / 50 | 0 / 53 |
Outcome results
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.
Time frame: Baseline; Week 16
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -2.5 abscesses and inflammatory nodules | Standard Error 0.88 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -5.2 abscesses and inflammatory nodules | Standard Error 0.86 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -6.9 abscesses and inflammatory nodules | Standard Error 0.88 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -6.3 abscesses and inflammatory nodules | Standard Error 0.85 |
p-value: 0.027795% CI: [-5.2, -0.3]MMRM
p-value: 0.000695% CI: [-6.8, -1.9]MMRM
p-value: 0.002195% CI: [-6.2, -1.4]MMRM
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 2 | -1.8 abscesses, INs, and DFs | Standard Error 0.74 |
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 4 | -2.7 abscesses, INs, and DFs | Standard Error 0.83 |
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 6 | -2.6 abscesses, INs, and DFs | Standard Error 0.92 |
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 8 | -2.6 abscesses, INs, and DFs | Standard Error 0.96 |
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 12 | -2.7 abscesses, INs, and DFs | Standard Error 0.99 |
| Placebo | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 16 | -2.4 abscesses, INs, and DFs | Standard Error 1.06 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 16 | -5.1 abscesses, INs, and DFs | Standard Error 1.03 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 8 | -4.4 abscesses, INs, and DFs | Standard Error 0.93 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 2 | -2.9 abscesses, INs, and DFs | Standard Error 0.72 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 6 | -4.7 abscesses, INs, and DFs | Standard Error 0.9 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 4 | -3.5 abscesses, INs, and DFs | Standard Error 0.82 |
| INCB054707 15 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 12 | -5.0 abscesses, INs, and DFs | Standard Error 0.97 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 4 | -5.7 abscesses, INs, and DFs | Standard Error 0.82 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 6 | -6.4 abscesses, INs, and DFs | Standard Error 0.92 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 8 | -7.5 abscesses, INs, and DFs | Standard Error 0.96 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 16 | -7.7 abscesses, INs, and DFs | Standard Error 1.05 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 12 | -7.7 abscesses, INs, and DFs | Standard Error 0.98 |
| INCB054707 45 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 2 | -4.0 abscesses, INs, and DFs | Standard Error 0.74 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 12 | -7.6 abscesses, INs, and DFs | Standard Error 0.95 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 16 | -7.6 abscesses, INs, and DFs | Standard Error 1.02 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 4 | -6.2 abscesses, INs, and DFs | Standard Error 0.8 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 8 | -6.8 abscesses, INs, and DFs | Standard Error 0.92 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 2 | -4.4 abscesses, INs, and DFs | Standard Error 0.71 |
| INCB054707 75 mg | Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 | Week 6 | -7.1 abscesses, INs, and DFs | Standard Error 0.89 |
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 8 | -2.7 abscesses and inflammatory nodules | Standard Error 0.82 |
| Placebo | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 4 | -3.0 abscesses and inflammatory nodules | Standard Error 0.71 |
| Placebo | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 12 | -2.8 abscesses and inflammatory nodules | Standard Error 0.84 |
| Placebo | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 6 | -2.7 abscesses and inflammatory nodules | Standard Error 0.77 |
| Placebo | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 2 | -1.7 abscesses and inflammatory nodules | Standard Error 0.69 |
| INCB054707 15 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 6 | -4.8 abscesses and inflammatory nodules | Standard Error 0.76 |
| INCB054707 15 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 8 | -4.7 abscesses and inflammatory nodules | Standard Error 0.79 |
| INCB054707 15 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 12 | -5.0 abscesses and inflammatory nodules | Standard Error 0.82 |
| INCB054707 15 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 4 | -3.6 abscesses and inflammatory nodules | Standard Error 0.7 |
| INCB054707 15 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 2 | -2.7 abscesses and inflammatory nodules | Standard Error 0.66 |
| INCB054707 45 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 6 | -5.3 abscesses and inflammatory nodules | Standard Error 0.77 |
| INCB054707 45 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 2 | -3.4 abscesses and inflammatory nodules | Standard Error 0.69 |
| INCB054707 45 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 4 | -4.8 abscesses and inflammatory nodules | Standard Error 0.71 |
| INCB054707 45 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 8 | -6.4 abscesses and inflammatory nodules | Standard Error 0.82 |
| INCB054707 45 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 12 | -6.7 abscesses and inflammatory nodules | Standard Error 0.84 |
| INCB054707 75 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 8 | -5.7 abscesses and inflammatory nodules | Standard Error 0.79 |
| INCB054707 75 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 4 | -5.3 abscesses and inflammatory nodules | Standard Error 0.69 |
| INCB054707 75 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 2 | -4.0 abscesses and inflammatory nodules | Standard Error 0.66 |
| INCB054707 75 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 6 | -6.2 abscesses and inflammatory nodules | Standard Error 0.75 |
| INCB054707 75 mg | Mean Change From Baseline in AN Count at Weeks 2 to 12 | Week 12 | -6.5 abscesses and inflammatory nodules | Standard Error 0.81 |
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 16 | -0.3 draining fistulas | Standard Deviation 2.05 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 6 | -0.2 draining fistulas | Standard Deviation 2.14 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 4 | 0.0 draining fistulas | Standard Deviation 1.8 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 12 | -0.3 draining fistulas | Standard Deviation 2.17 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 8 | -0.2 draining fistulas | Standard Deviation 2.46 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 2 | -0.2 draining fistulas | Standard Deviation 1.23 |
| Placebo | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Baseline | 2.4 draining fistulas | Standard Deviation 3.97 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 6 | 0.1 draining fistulas | Standard Deviation 1.85 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Baseline | 2.3 draining fistulas | Standard Deviation 4.44 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 2 | -0.2 draining fistulas | Standard Deviation 1.01 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 4 | 0.0 draining fistulas | Standard Deviation 1.11 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 8 | 0.2 draining fistulas | Standard Deviation 2.1 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 12 | 0.0 draining fistulas | Standard Deviation 2.71 |
| INCB054707 15 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 16 | 0.1 draining fistulas | Standard Deviation 3.25 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 2 | -0.6 draining fistulas | Standard Deviation 1.62 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 6 | -1.0 draining fistulas | Standard Deviation 2.95 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 8 | -1.1 draining fistulas | Standard Deviation 2.82 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Baseline | 2.2 draining fistulas | Standard Deviation 4.04 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 16 | -0.8 draining fistulas | Standard Deviation 3.2 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 12 | -1.0 draining fistulas | Standard Deviation 2.87 |
| INCB054707 45 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 4 | -0.8 draining fistulas | Standard Deviation 2.59 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 12 | -1.0 draining fistulas | Standard Deviation 2.61 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 2 | -0.2 draining fistulas | Standard Deviation 1.3 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 6 | -0.8 draining fistulas | Standard Deviation 2.62 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Baseline | 1.6 draining fistulas | Standard Deviation 2.85 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 16 | -1.1 draining fistulas | Standard Deviation 2.57 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 4 | -0.6 draining fistulas | Standard Deviation 2.44 |
| INCB054707 75 mg | Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 | Change from Baseline at Week 8 | -0.8 draining fistulas | Standard Deviation 2.7 |
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Week 2 | -2.4 scores on a scale | Standard Error 1.17 |
| Placebo | 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 | Week 4 | -2.1 scores on a scale | Standard Error 1.52 |
| Placebo | 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 | Week 6 | -3.1 scores on a scale | Standard Error 1.77 |
| Placebo | 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 | Week 8 | -3.0 scores on a scale | Standard Error 1.85 |
| Placebo | 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 | Week 12 | -3.1 scores on a scale | Standard Error 1.8 |
| Placebo | 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 | Week 16 | -3.1 scores on a scale | Standard Error 1.96 |
| INCB054707 15 mg | 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 | Week 16 | -5.6 scores on a scale | Standard Error 1.92 |
| INCB054707 15 mg | 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 | Week 8 | -4.0 scores on a scale | Standard Error 1.79 |
| INCB054707 15 mg | 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 | Week 2 | -3.8 scores on a scale | Standard Error 1.13 |
| INCB054707 15 mg | 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 | Week 6 | -4.7 scores on a scale | Standard Error 1.73 |
| INCB054707 15 mg | 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 | Week 4 | -3.9 scores on a scale | Standard Error 1.49 |
| INCB054707 15 mg | 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 | Week 12 | -5.5 scores on a scale | Standard Error 1.76 |
| INCB054707 45 mg | 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 | Week 4 | -9.3 scores on a scale | Standard Error 1.51 |
| INCB054707 45 mg | 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 | Week 6 | -10.7 scores on a scale | Standard Error 1.75 |
| INCB054707 45 mg | 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 | Week 8 | -11.8 scores on a scale | Standard Error 1.83 |
| INCB054707 45 mg | 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 | Week 16 | -11.0 scores on a scale | Standard Error 1.96 |
| INCB054707 45 mg | 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 | Week 12 | -11.8 scores on a scale | Standard Error 1.79 |
| INCB054707 45 mg | 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 | Week 2 | -6.7 scores on a scale | Standard Error 1.16 |
| INCB054707 75 mg | 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 | Week 12 | -11.9 scores on a scale | Standard Error 1.73 |
| INCB054707 75 mg | 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 | Week 16 | -12.1 scores on a scale | Standard Error 1.9 |
| INCB054707 75 mg | 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 | Week 4 | -9.3 scores on a scale | Standard Error 1.47 |
| INCB054707 75 mg | 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 | Week 8 | -10.7 scores on a scale | Standard Error 1.78 |
| INCB054707 75 mg | 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 | Week 2 | -6.1 scores on a scale | Standard Error 1.12 |
| INCB054707 75 mg | 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 | Week 6 | -10.6 scores on a scale | Standard Error 1.71 |
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.
Time frame: up to Week 16
Population: Safety Population: all participants who received at least 1 dose of INCB054707 or placebo during the Placebo-controlled Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 34 Participants |
| INCB054707 15 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 31 Participants |
| INCB054707 45 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 30 Participants |
| INCB054707 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 32 Participants |
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.
Time frame: Baseline; Week 16
Population: ITT Population. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 28.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 48.1 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 44.2 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 45.3 percentage of participants |
p-value: 0.044595% CI: [1, 5.3]Wald test
p-value: 0.099895% CI: [0.9, 4.6]Wald test
p-value: 0.082995% CI: [0.9, 4.7]Wald test
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 8 | 28.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 4 | 25.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 12 | 30.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 6 | 17.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 2 | 15.4 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 6 | 32.7 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 8 | 36.5 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 12 | 42.3 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 4 | 36.5 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 2 | 25.0 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 6 | 48.1 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 2 | 34.6 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 4 | 44.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 8 | 44.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 12 | 48.1 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 8 | 52.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 4 | 49.1 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 2 | 34.0 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 6 | 52.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 | Week 12 | 58.5 percentage of participants |
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 16 | 17.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 2 | 1.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 12 | 23.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 8 | 21.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 4 | 7.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 4 | 30.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 6 | 13.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 12 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 4 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 6 | 32.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 2 | 15.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 16 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 12 | 5.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 8 | 36.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 8 | 5.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 12 | 44.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 16 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 6 | 5.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 4 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 16 | 36.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 8 | 3.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 2 | 0.0 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 8 | 55.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 2 | 25.0 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 4 | 44.2 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 6 | 46.2 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 12 | 51.9 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 16 | 55.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 2 | 9.6 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 4 | 15.4 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 6 | 25.0 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 8 | 28.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 12 | 32.7 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 16 | 36.5 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 2 | 3.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 4 | 5.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 6 | 5.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 8 | 15.4 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 12 | 17.3 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 16 | 17.3 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 2 | 3.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 4 | 3.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 6 | 3.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 8 | 13.5 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 12 | 13.5 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 16 | 15.4 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 16 | 36.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 16 | 57.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 2 | 1.9 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 2 | 34.6 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 4 | 7.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 12 | 55.8 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 8 | 53.8 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 6 | 11.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 8 | 11.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 8 | 19.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 6 | 7.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 12 | 13.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 6 | 51.9 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 16 | 11.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 16 | 19.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 2 | 1.9 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 4 | 46.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 12 | 11.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 4 | 23.1 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 4 | 5.8 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 6 | 32.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 8 | 32.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 2 | 13.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 12 | 36.5 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 4 | 5.7 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 16 | 18.9 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 6 | 9.4 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 4 | 58.5 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 2 | 11.3 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 12 | 62.3 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 16 | 17.0 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 16 | 52.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 4 | 5.7 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 2 | 7.5 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 8 | 37.7 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 12 | 18.9 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 6 | 9.4 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 8 | 54.7 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 4 | 18.9 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 2 | 39.6 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 8 | 18.9 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 16 | 34.0 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN50, Week 6 | 56.6 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN100, Week 8 | 17.0 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 12 | 39.6 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN90, Week 12 | 20.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 6 | 26.4 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 | AN75, Week 2 | 20.8 percentage of participants |
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.
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 16 | 17.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 8 | 19.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 2 | 1.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 6 | 9.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 12 | 19.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 4 | 7.7 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 12 | 26.9 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 16 | 30.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 4 | 15.4 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 2 | 9.6 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 6 | 17.3 percentage of participants |
| INCB054707 15 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 8 | 23.1 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 2 | 13.5 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 4 | 21.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 12 | 32.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 8 | 30.8 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 16 | 28.8 percentage of participants |
| INCB054707 45 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 6 | 28.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 16 | 30.2 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 2 | 18.9 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 4 | 15.1 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 6 | 24.5 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 12 | 39.6 percentage of participants |
| INCB054707 75 mg | Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 | Week 8 | 35.8 percentage of participants |
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.
Time frame: Weeks 2, 4, 6, 8, 12, and 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 2 | 4.3 percentage of participants |
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 4 | 14.3 percentage of participants |
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 6 | 13.3 percentage of participants |
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 8 | 28.9 percentage of participants |
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 12 | 28.9 percentage of participants |
| Placebo | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 16 | 25.6 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 16 | 44.4 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 8 | 30.0 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 2 | 9.8 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 6 | 19.1 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 4 | 20.0 percentage of participants |
| INCB054707 15 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 12 | 33.3 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 4 | 20.0 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 6 | 31.3 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 8 | 38.3 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 16 | 51.2 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 12 | 46.7 percentage of participants |
| INCB054707 45 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 2 | 16.7 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 12 | 38.8 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 16 | 37.0 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 4 | 23.1 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 8 | 41.2 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 2 | 23.1 percentage of participants |
| INCB054707 75 mg | Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 | Week 6 | 38.8 percentage of participants |