Psoriasis
Conditions
Brief summary
This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.
Interventions
DRUGLY3462817 - IV
Administered IV
DRUGLY3462817 - SC
Administered SC
DRUGPlacebo - IV
Administered IV
DRUGPlacebo - SC
Administered SC
DRUGLY3509754
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have been diagnosed with psoriasis for at least 6 months * Participants must have active psoriasis plaques * Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)
Exclusion criteria
* Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1) * Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754 | Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754 | Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754) | PK: Cave of LY3462817 and LY3509754 |
Countries
Canada, United States
Outcome results
None listed