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About
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical efficacy outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.
Enrollment
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Volunteers
Inclusion criteria
Part A:
Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
Participant must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Participant has a body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive)
Participant can be male or female
A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the final dose of investigational medicinal product (IMP), and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of IMP
Part B:
Participant must be 18 to 65 years of age inclusive at the time of signing the ICF
Participant has a documented history of moderate or severe atopic dermatitis (AtD) that has been present for at least 12 months prior to initiating the study (signing of the ICF) and with:
Participant has a body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive)
Participant can be male or female
A male participant must agree to use contraception during the Treatment Period and for at least 60 days after the final dose of IMP, and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 60 days after the final dose of IMP
Exclusion criteria
Part A:
Part B:
Primary purpose
Allocation
Interventional model
Masking
107 participants in 11 patient groups, including a placebo group
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Central trial contact
UCB Cares; UCB Cares
Data sourced from clinicaltrials.gov
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