Clinical trial NCT03418493: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Official title: A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-02-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).

This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy Participants

  * Are overtly healthy males or females, as determined by medical history and physical examination
  * Females must be of non-childbearing potential
  * Are between 18 and 64 years of age, inclusive, at screening
  * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
  * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Psoriasis Participants:

  * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
  * Meet psoriasis disease activity criteria
  * Are at least 18 years of age
  * Have a minimum body weight of 50 kilograms (kg)

Exclusion Criteria:

* Healthy and Psoriasis Participants

  * Have known or ongoing neuropsychiatric disorders
  * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study
  * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline
  * Show evidence of active or latent tuberculosis (TB)
  * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data
* Psoriasis Participants Only:

  * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)
  * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
  * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline
  * Have received topical psoriasis treatment within 14 days of baseline

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Pre-dose up to 1 year after administration of study drug
Secondary outcomes:
measure: Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
timeFrame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
measure: Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
timeFrame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
measure: Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
timeFrame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
timeFrame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
measure: Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
timeFrame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
measure: Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
timeFrame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
city: Baltimore
country: United States
facility: PAREXEL-Phase 1 Baltimore Harbor Hospital Center
state: Maryland
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: