A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

Conditions

• Vitiligo

Eligibility Criteria

Sex

ALL

Age

12 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib 1.5% cream — DRUG
  Ruxolitinib cream 1.5% applied twice a day (BID).
• 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

Study Details

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Key Dates

Start date

May 5, 2022

Status verified

Feb 2025

Primary completion

Dec 19, 2023

Completion

Dec 19, 2023

Study Design

Enrollment

55 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
  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.
• Experimental: Group B: Ruxolitinib Monotherapy
  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.

Primary Outcome Measure

Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 [ Time Frame: Baseline; Week 48 ]

Locations (11)

Find similar trials in Fountain Valley, CA

Related Studies

• A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
  PHASE2 · Recruiting · Eli Lilly and Company · Phoenix, Arizona
• The Gut and Skin Microbiome in Vitiligo Disease Progression
  Recruiting · Northwestern University · Chicago, Illinois