Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ruxolitinib, ruxolitinib, Ruxolitinib Topical Cream, Ruxolitinib Cream, topical ruxolitinib 1.5% cream, Ruxolitinib Oral Tablet [Jakafi], Ruxolitinib (Rux)
Ruxolitinib 1.5% · 8 trials · 4 indications
WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.
Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%.
Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling
The proportion of patients with complete re-epithelization, defined as 100% re-epithelialization without any drainage, of the target ulcer at week 24.
T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area \[BSA\] estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value)\*100.
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Number of participants with TEAEs leading to dose interruption or discontinuation.
| Arm | Type | Description |
|---|---|---|
| Ruxolitinib 1.5% Cream | EXPERIMENTAL | Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. |
| Vehicle Cream | PLACEBO_COMPARATOR | Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks. |
| Cohort A : ruxolitinib cream | EXPERIMENTAL | Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream. |
| Cohort A : Vehicle | PLACEBO_COMPARATOR | Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream. |
| Cohort B : roxolitinib cream | EXPERIMENTAL | Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream. |
| Ruxolitinib Cream | ACTIVE_COMPARATOR | Participants will receive topical ruxolitinib 1.5% cream |
| Healthy Control Subjects | NO_INTERVENTION | Age- and gender-matched healthy control subjects |
| Treatment | EXPERIMENTAL | Treated with topical ruxolitinib thin laywer twice daily for 24 weeks. |
| Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB) | EXPERIMENTAL | Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study. |
| Group B: Ruxolitinib Monotherapy | EXPERIMENTAL | Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone. |
| Ruxolitinib cream 1.5% twice daily (BID) | EXPERIMENTAL | Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension. |
| Ruxolitinib cream 1.5% once daily (QD) | EXPERIMENTAL | Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension. |
| Ruxolitinib cream 0.5% QD | EXPERIMENTAL | Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension. |
| Ruxolitinib cream 0.15% QD | EXPERIMENTAL | Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if \< 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension. |
| Vehicle BID | PLACEBO_COMPARATOR | Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension. |
| Maximal Use Ruxolitinib 1.5% | EXPERIMENTAL | Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions. |
| Name | Type | Description |
|---|---|---|
| Ruxolitinib Cream | DRUG | Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period. |
| Vehicle Cream | DRUG | Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period. |
| ruxolitinib | DRUG | ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID. |
| Vehicle | DRUG | Vehicle cream is a topical formulation applied as a thin film to affected areas. |
| Ruxolitinib 1.5% Cream | DRUG | topical ruxolitinib 1.5% cream twice daily for 4 weeks |
| topical ruxolitinib 1.5% cream | DRUG | topical ruxolitinib 1.5% cream applied to wound bed twice daily for 24 weeks. |
| NB-UVB phototherapy | DEVICE | NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit |
| Ruxolitinib Cream 1.5% | DRUG | Ruxolitinib Cream 1.5% |
Inclusion Criteria: * Clinical diagnosis of PN ≥ 3 months before screening. * ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA. * IGA-CPG-S score of ≥ 2 at screening and baseline. * Baseline PN-related WI-NR...
Ruxolitinib is a small molecule kinase inhibitor being studied for multiple conditions including Lichen Sclerosus, Pancreatic Cancer, Polycythemia Vera, Exanthema, Prurigo, and T-cell Lymphoma. It is also being investigated in clinical trials for graft-versus-host disease, hypereosinophilic syndrome, and vitiligo. The drug is in Phase 2 clinical development for these indications.
Ruxolitinib is a kinase inhibitor, specifically a -tinib class drug that targets JAK kinases. It works by inhibiting the activity of these enzymes, which play a role in inflammatory and immune responses. This mechanism is relevant to its investigation in various oncology and inflammatory conditions.
Ruxolitinib is developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Ruxolitinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for the indications listed. The drug is being studied in multiple Phase 2 trials, with some completed and others ongoing.
Ruxolitinib has been studied in several clinical trials. NCT02953678 is a completed Phase 2 study in steroid-refractory acute graft-versus-host disease. NCT03112603 is a completed Phase 3 study in chronic graft-versus-host disease. NCT03801434 is an active Phase 2 trial in hypereosinophilic syndrome. NCT05750823 is a completed Phase 2 trial in genital vitiligo.
Ruxolitinib is also known as Ruxolitinib Oral Tablet, marketed under the brand name Jakafi. The drug is available in different formulations, including a topical cream and an oral tablet. The oral form is Jakafi, while the topical cream is referred to as Ruxolitinib Cream or topical ruxolitinib 1.5% cream.