The purpose of this clinical trial is to learn how well ACT-777991 works, how safe it is and how well it is tolerated by adults with non-segmental vitiligo.
The main question this clinical trial aims to answer is:
• Can ACT-777991 help return color to the skin of the face of adults with non-segmental vitiligo?
Researchers will compare ACT-777991 to placebo (a look-alike inactive treatment that contains no medicine) to see if ACT-777991 works to treat non-segmental vitiligo.
Trial participants will:
* Take the trial intervention (either ACT-777991 or placebo) daily for 24 weeks. * Visit the clinic 7 times for check-up and tests.
F-VASI score ≥ 0.3 based on BICR at Screening.
T-VASI score ≥ 5 based on investigator assessment at Screening and Randomization.
Total body surface area (BSA) involvement, including the face, ≤ 50% based on investigator assessment at Screening and Randomization.
Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.
Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or depigmentation disorders (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation).
Any autoimmune disease, except adequately treated thyroid disease.
History of systemic immunotherapy treatment, including JAK inhibitors, for any inflammatory disease in the 12 months prior to Randomization.
History of topical JAK inhibitors for any inflammatory disease in the 6 weeks prior to Screening.
Parallel
ACT-777991
DrugACT-777991 tablets
Placebo
DrugACT-777991-matching placebo tablets
Main primary outcome measure: Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) based on Blinded Independent Central Reading (BICR) at Week 24
The vitiligo area scoring index (VASI) is a validated clinician-reported outcome measure that scores both the extent (surface area) and degree (level of depigmentation) of vitiligo lesions over time. The F-VASI describes involvement of the face, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement.
Supplementary primary outcome measure: Percentage change from baseline in F-VASI based on investigator assessment at Week 24
Supplementary primary outcome measure: Percentage change from baseline in F-VASI at Week 4, 8 and 16
F-VASI will be assessed by the investigator and by BICR.
Supplementary primary outcome measure: Achievement of F-VASI50 at Week 4, 8, 16 and 24
Proportion of patients achieving at least a 50% improvement from baseline in F-VASI.
Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 16 and 24
The T-VASI is calculated using a formula that includes contributions from all body regions, with higher scores indicating more severe disease. The F-VASI is used as the score for the 'face' component , i.e., the face is not be scored again. Negative changes from baseline indicate improvement. T-VASI will be assessed by the investigator.
Achievement of T-VASI50 at Week 4, 8, 16 and 24
Proportion of patients achieving at least a 50% improvement from baseline in T-VASI.
Adverse events (AEs) leading to premature discontinuation of trial intervention
Treatment-emergent AEs and serious AEs (SAEs)
Treatment-emergent events are AEs and SAEs reported for the first time or as worsening of a pre-existing event after first dose of trial intervention up to 37 days after last dose of trial intervention (Follow-up visit).
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This trial is not recruiting at the moment. You can still explore other options:
