Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma SRL
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
You may not be if
Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
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