Phase 2
N=157
A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT03099304 ↗Enrolled (actual)
157
Serious AEs
2.5%
Results posted
Dec 2021
Primary outcome: Primary: Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 — 3.1; 32.3; 25.8; 50.0 percentage of participants — p=0.0057
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib cream (Drug); Vehicle cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 |
3.1; 32.3; 25.8; 50.0; 45.5 | 0.0057 sig |
| SECONDARY Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear |
0; 3.2; 9.7; 13.3; 9.1 | 0.4936 |
| SECONDARY Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 |
50; 21.4; 16.7; 15.4; 25.8; 30.0 | 0.9794 |
| SECONDARY Dose Response on Percentage Change From Baseline in F-VASI |
— | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 |
20; 20; 22; 22; 20; 0 | — |
| SECONDARY Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 |
26; 23; 23; 2; 1; 1 | — |
| SECONDARY Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 |
9; 6; 5; 9; 0; 0 | — |
| SECONDARY Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE |
26; 1 | — |
| SECONDARY Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 |
15; 16; 13; 25; 0; 2 | — |
| SECONDARY Mean Change From Baseline in F-VASI Score at Week 24 |
0.05; -0.39; -0.35; -0.63; -0.46 | 0.0056 sig |
| SECONDARY Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 |
0.77; 1.21; 1.66; 1.14; 1.22; 1.45 | — |
| SECONDARY Percentage Change From Baseline in F-VASI Score at Week 24 |
6.02; -30.69; -29.10; -40.00; -37.78 | 0.0005 sig |
| SECONDARY Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 |
-72.21; -50.60; -52.43; -40.79; -45.54; -55.63 | — |
| SECONDARY Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 |
90.0; 64.3; 50.0; 38.5; 45.2; 43.3 | — |
| SECONDARY Percentage Change From Baseline in F-BSA Repigmentation at Week 24 |
6.49; -19.82; -17.55; -19.53; -27.76 | — |
| SECONDARY Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 |
-55.18; -37.94; -33.39; -15.64; -34.67; -38.37 | — |
| SECONDARY Percentage Change From Baseline in T-BSA Repigmentation at Week 24 |
3.35; -13.97; -10.83; -17.19; -13.60 | — |
| SECONDARY Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 |
-39.53; -8.72; -2.72; -8.73; -15.13; -27.33 | — |
| SECONDARY Mean Change From Baseline in T-VASI Score at Week 24 |
0.57; -2.27; -2.18; -4.51; -3.52 | 0.0326 sig |
| SECONDARY Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 |
9.56; 13.47; 22.82; 20.75; 18.43; 20.55 | — |
| SECONDARY Percentage Change From Baseline in T-VASI Score at Week 24 |
2.65; -20.88; -15.82; -27.16; -22.91 | 0.0010 sig |
| SECONDARY Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 |
-50.71; -25.12; -19.75; -20.00; -24.67; -41.90 | — |
| SECONDARY Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading |
1.78; 2.74; 1.84; 1.83; 1.21; -1.12 | — |
| SECONDARY Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading |
2.73; 2.43; 1.21; 2.21; 1.84; 1.83 | — |
| SECONDARY Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area |
22.81; 16.26; 22.35; 24.63; 20.79; 0.38 | — |
| SECONDARY Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area |
9.18; 16.43; 24.50; 24.50; 22.35; 24.63 | — |
| SECONDARY Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area |
2.61; -10.61; -13.87; -14.09; -13.10 | — |
| SECONDARY Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area |
-32.01; -7.39; -10.57; -7.13; -19.73; -22.36 | — |
| SECONDARY Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging |
10.03; 9.29; 10.03; 9.97; 8.42; -1.15 | — |
| SECONDARY Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging |
8.64; 8.43; 11.29; 10.07; 10.03; 9.97 | — |
| SECONDARY Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging |
-7.58; -17.52; -13.55; -17.00; -4.46 | — |
| SECONDARY Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging |
-33.48; -12.70; -17.31; -23.88; -21.45; -30.00 | — |
| SECONDARY Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.4936 |
| SECONDARY Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 |
0.0; 0.0; 0.0; 0.0; 6.9; 4.8 | — |
| SECONDARY Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 |
0.0; 0.0; 0.0; 0.0; 0.0; 9.4 | — |
| SECONDARY Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 |
0.0; 0.0; 3.2; 0.0; 0.0; 6.3 | — |
| SECONDARY Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 |
7.4; 3.8; 6.7; 11.5; 6.5; 0.0 | — |
| SECONDARY Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 |
0.0; 7.1; 8.3; 7.7; 10.3; 4.8 | — |
| SECONDARY Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 |
7.4; 23.1; 20.0; 30.8; 29.0 | — |
| SECONDARY Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 |
30.0; 21.4; 33.3; 30.8; 31.0; 52.4 | — |
| SECONDARY Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score |
NA; 197.0; 339.0; 172.0; 170.0 | — |
| SECONDARY Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score |
NA; NA; NA; NA; 376.0 | — |
| SECONDARY Time to Achieve an F-PhGVA of Clear or Almost Clear |
NA; 372.0; NA; NA; NA | — |
| SECONDARY Time to Achieve an T-PhGVA of Clear or Almost Clear |
NA; 372.0; NA; NA; NA | — |
| SECONDARY Time to Achieve a PaGIC-V of Very Much Improved or Much Improved |
NA; NA; NA; 282.0; 281.0 | — |
Summary
The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of vitiligo.
- Vitiligo with depigmented areas including:
- at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm [without digits]) AND
- at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints [palm plus 5 digits]).
- Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion Criteria
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Participants who are receiving any kind of phototherapy, including tanning beds.
- Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
- Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
- Participants who have received any of the following treatments within the minimum specified timeframes.
- Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
- Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
- Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
- Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
- Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
- Participants with protocol-defined cytopenias at screening
- Participants with severely impaired liver function.
- Participants with impaired renal function.
- Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
- Participants who have previously received JAK inhibitor therapy, systemic or topical.
Data sourced from ClinicalTrials.gov (NCT03099304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.