Idorsia Pharmaceuticals Ltd.
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.
The trial includes three trial periods: Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 2:1 ratio to receive either ACT-777991 or placebo for 24 weeks (Trial intervention period). On completion of treatment, participants will be followed for 30 (+7) days (Follow-up period). Trial participation will end with a Follow-up visit (Participant Last Visit) at the end of the Follow-up period. The maximum trial duration for an individual participant is approximately 33 weeks including a screening p…
Inclusion Criteria: * Clinical diagnosis of either active or stable non segmental vitiligo for at least 3 months prior to Screening and meet all the following criteria: * 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. Applicable only to…
ACT-777991 tablets
ACT-777991-matching placebo tablets