Fig. 1: CONSORT diagrams of patient disposition.

a, PRIME. No patients were lost to follow-up at the time of the cutoff date. ^*Low-to-medium potency TCS/TCI as background therapy permitted (maintain dose from screening to end of treatment (EOT)). ^†Patient’s decision (fear of being exposed to Coronavirus Disease 2019 (COVID-19)). ^‡One patient experienced a serious adverse event (SAE) of Hodgkin’s disease; one patient experienced an SAE of duodenal ulcer perforation; and one patient experienced a non-serious event of neurodermatitis. ^§None was related to safety issues, lack of efficacy or COVID-19. ^‖Poor compliance to protocol. b, PRIME2. No patients were lost to follow-up at the time of the cutoff date. ^*Low-to-medium potency TCS/TCI as background therapy permitted (maintain dose from screening to EOT). ^†No discontinuations related to COVID-19. ^‡Patient could not continue the self-administration of investigational medicinal product. ^§None of the ‘other’ reasons for permanent study intervention discontinuation was related to safety or lack of efficacy. All were reported as the reason for withdrawal by the subject.