Phase 3
N=344
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
Non-segmental Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT04057573 ↗Enrolled (actual)
344
Serious AEs
1.4%
Results posted
Sep 2022
Primary outcome: Primary: Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 — 30.9; 11.4 percentage of participants — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruxolitinib cream (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 |
30.9; 11.4 | 0.0004 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 |
51.4; 20.9 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 |
16.3; 1.3 | 0.0065 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 |
23.9; 6.8 | 0.0006 sig |
| SECONDARY Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 |
20.5; 4.9 | 0.0013 sig |
| SECONDARY Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 |
-26.4; -7.0 | < 0.0001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period |
114; 39 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period |
82; 38 | — |
| SECONDARY Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 |
63.9; 32.0 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 |
82.5; 71.6; 74.0; 49.4; 48.0; 29.6 | — |
| SECONDARY Percentage Change From Baseline in F-VASI at Week 24 |
-44.39; -15.80 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in F-VASI at Week 52 |
-63.75; -43.50 | — |
| SECONDARY Percentage Change From Baseline in F-BSA at Week 52 |
-41.81; -23.45 | — |
| SECONDARY Percentage Change From Baseline in T-VASI at Week 24 |
-28.85; -8.99 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in T-VASI at Week 52 |
-46.80; -30.11 | — |
| SECONDARY Percentage Change From Baseline in T-BSA at Week 24 |
-14.23; -2.28 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in T-BSA at Week 52 |
-26.04; -13.54 | — |
| SECONDARY Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 |
50.2; 21.2; 8.0; 1.8; 1.0; 0.0 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 |
76.8; 53.1; 49.2; 22.2; 20.9; 8.6 | — |
| SECONDARY Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) |
8.5; 11.2; 30.7; 58.2; 40.2; 25.5 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24 |
-1.19; -0.59 | 0.2350 |
| SECONDARY Change From Baseline in DLQI at Week 52 |
4.37; 5.38; -0.84; -1.15 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) |
1.29; 6.33; 0.00; -2.33; 1.19; -1.00 | — |
| SECONDARY Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 |
61.0; 54.5; 57.0; 48.2 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
- Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.
Key Exclusion Criteria
- No pigmented hair within any of the vitiligo areas on the face.
- Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- Use of protocol-defined treatments within the indicated washout period before baseline.
Data sourced from ClinicalTrials.gov (NCT04057573). 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.