Clinical trial NCT04152382: A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis
Official title: A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754
timeFrame: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Secondary outcomes:
measure: Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
timeFrame: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Associates - Los Angeles
state: California
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Hazleton
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: Cobourg
country: Canada
facility: Skin Health
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: