Phase 3
N=458
Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT04530344 ↗Enrolled (actual)
458
Serious AEs
2.6%
Results posted
Jul 2023
Primary outcome: Primary: Time to Relapse (Defined as <F-VASI75) — NA; NA days — p=0.0414
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ruxolitinib (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse (Defined as <F-VASI75) |
NA; NA | 0.0414 sig |
| SECONDARY Time to Loss of Adequate Response |
195.0; NA | 0.0003 sig |
| SECONDARY Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period |
98.2; 98.2; 45.8; 65.6; 98.2; 96.4 | — |
| SECONDARY Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period |
98.2; 98.2; 16.1; 30.8; 96.4; 96.4 | — |
| SECONDARY Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period |
98.2; 96.5; 0.0; 2.3; 89.3; 94.5 | — |
| SECONDARY Mean F-VASI Scores During the Extension Treatment Period |
0.86; 0.99; 0.88; 0.91; 0.05; 0.07 | — |
| SECONDARY Change From Baseline in F-VASI Scores During the Extension Treatment Period |
-0.81; -0.92; -0.37; -0.51; -0.82; -0.90 | — |
| SECONDARY Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period |
-94.45; -94.50; -44.32; -54.72; -93.79; -93.21 | — |
| SECONDARY Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period |
80.7; 71.9; 16.9; 42.5; 76.8; 72.7 | — |
| SECONDARY Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period |
38.6; 42.1; 3.4; 12.2; 42.9; 43.6 | — |
| SECONDARY Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period |
12.3; 12.3; 0.0; 2.3; 12.5; 14.5 | — |
| SECONDARY Mean T-VASI Scores During the Extension Treatment Period |
6.06; 6.27; 6.69; 6.74; 2.38; 2.36 | — |
| SECONDARY Change From Baseline in T-VASI Scores During the Extension Treatment Period |
-3.68; -3.91; -1.45; -2.83; -3.71; -3.91 | — |
| SECONDARY Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period |
-65.01; -64.95; -24.75; -42.14; -65.16; -65.69 | — |
| SECONDARY Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period |
0.92; 1.10; 1.01; 1.02; 0.18; 0.27 | — |
| SECONDARY Change From Baseline in F-BSA During the Extension Treatment Period |
-0.74; -0.83; -0.20; -0.31; -0.76; -0.82 | — |
| SECONDARY Percent Change From Baseline in F-BSA During the Extension Treatment Period |
-80.75; -76.75; -22.15; -29.06; -80.23; -74.42 | — |
| SECONDARY Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period |
6.79; 6.85; 7.42; 7.49; 4.09; 4.20 | — |
| SECONDARY Change From Baseline in T-BSA During the Extension Treatment Period |
-2.70; -2.64; -0.47; -1.52; -2.74; -2.70 | — |
| SECONDARY Percent Change From Baseline in T-BSA During the Extension Treatment Period |
-43.81; -41.50; -8.54; -20.57; -44.22; -43.12 | — |
| SECONDARY Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period |
49.1; 42.1; 11.9; 35.3; 48.2; 34.5 | — |
| SECONDARY Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period |
2.87; 4.10; 3.69; 3.53; 0.11; -0.47 | — |
| SECONDARY Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period |
1.67; 1.00; 1.25; 2.32; -1.00; -0.17 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
21; 3; 32; 59; 114 | — |
| SECONDARY Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 |
7.28; 5.56; 5.85; 15.1; 12.7; 13.1 | — |
Summary
The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.
Eligibility Criteria
Inclusion Criteria
- Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
- Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
- Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
- Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
- Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.
Exclusion Criteria
- Has been permanently discontinued from study treatment in the parent study for any reason.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding woman.
- Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
Data sourced from ClinicalTrials.gov (NCT04530344). 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.