Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Povorcitinib · 16 trials · 11 indications
Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.
Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).
≥75% improvement in facial Vitiligo Area Scoring Index.
HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
Defined as the maximum observed plasma concentration.
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Defined as the maximum observed plasma concentration.
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Defined as the maximum observed plasma concentration.
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Defined as the maximum observed plasma concentration.
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Povorcitinib concentration in dermal.
Povorcitinib concentration in plasma.
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
Electrocardiogram measurement of change from baseline in HR.
Electrocardiogram measurement of change from baseline in PR.
Electrocardiogram measurement of change from baseline in QRS.
Digoxin concentration in plasma.
Rosuvastatin concentration in plasma.
Metformin concentration in plasma.
LNG concentration in plasma.
EE concentration in plasma.
| Arm | Type | Description |
|---|---|---|
| povorcitinib | EXPERIMENTAL | Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled. |
| Povorcitinib Dose 1 | EXPERIMENTAL | Povorcitinib at the protocol-defined dose. |
| Povorcitinib Dose 2 | EXPERIMENTAL | Povorcitinib at the protocol-defined dose. |
| Placebo | PLACEBO_COMPARATOR | Placebo at the protocol-defined dose. |
| Cohort A | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Cohort B | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Cohort C | EXPERIMENTAL | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
| Experimental: Povorcitinib Dose A | EXPERIMENTAL | Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
| Povorcitinib Dose A | EXPERIMENTAL | Participants will receive Povorcitinib Dose A for 54 weeks. |
| Povorcitinib Dose B | EXPERIMENTAL | Participants will receive Povorcitinib Dose B for 54 weeks. |
| Povorcitinib Dose C | EXPERIMENTAL | Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period. |
| Placebo followed by Povorcitinib Dose A, B, or C | EXPERIMENTAL | Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period. |
| Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo | PLACEBO_COMPARATOR | Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks |
| ICS-LABA + povorcitinib Dose 1 | EXPERIMENTAL | Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks |
| ICS-LABA + povorcitinib Dose 2 | EXPERIMENTAL | Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks |
| ICS-LABA + povorcitinib Dose 3 | EXPERIMENTAL | Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks |
| Cohort 1: Ruxolitinib 1.5 % Cream | EXPERIMENTAL | Ruxolitinib cream applied topically twice daily. |
| Cohort 2: Povorcitinib | EXPERIMENTAL | Povorcitinib will be administered at the protocol defined dose. |
| Cohort 3: Povorcitinib | EXPERIMENTAL | Povorcitinib will be administered at the protocol defined dose. |
| Treatment Group 1 | EXPERIMENTAL | Povorcitinib and placebo will be administered at the protocol defined doses. |
| Treatment Group 2 | EXPERIMENTAL | Povorcitinib will be administered at the protocol defined doses. |
| Treatment Group 3 | PLACEBO_COMPARATOR | Placebo will be administered at the protocol defined doses. |
| Treatment Group 4 | ACTIVE_COMPARATOR | Moxifloxacin will be administered at the protocol defined doses. |
| Cohort 1: Dose | EXPERIMENTAL | Digoxin and povorcitinib will be administered at protocol defined doses. |
| Cohort 2: Dose | EXPERIMENTAL | Rosuvastatin and povorcitinib will be administered at protocol defined doses. |
| Cohort 3: Dose | EXPERIMENTAL | Metformin and povorcitinib will be administered at protocol defined doses. |
| Cohort 4: Dose | EXPERIMENTAL | Probenecid and povorcitinib will be administered at protocol defined doses. |
| Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) | EXPERIMENTAL | Povorcitinib and LNG/EE will be administered at the protocol defined doses. |
| Name | Type | Description |
|---|---|---|
| povorcitinib | DRUG | Study drug will be taken orally as defined by the protocol. |
| Placebo | DRUG | Oral Tablet |
| ICS-LABA | DRUG | Background Therapy |
| Ruxolitinib | DRUG | Ruxolitinib cream applied topically. |
| Moxifloxacin | DRUG | Moxifloxacin will be administered at protocol defined dose. |
| Digoxin | DRUG | Oral; Tablet |
| Rosuvastatin | DRUG | Oral; Tablet |
| Metformin | DRUG | Oral; Tablet |
| Probenecid | DRUG | Oral; Tablet |
| Levonorgestrel/Ethinyl estradiol | DRUG | Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose. |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * Received clinical benefit from ...