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Official Title: A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
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.
- Group B: Ruxolitinib MonotherapyParticipants 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.
Device: NB-UVB phototherapyNB-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
Actual Study Start Date: May 5, 2022
Estimated Study Completion Date: January 23, 2024
Contact: Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US)
+800 00027423
eumedinfo@incyte.com
https://beta.clinicaltrials.gov/study/NCT05247489
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