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CompletedNCT03418493Updated Sep 21, 2023Results posted

A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis

A Phase 1 interventional study of LY3316531 - IV and LY3316531 - SC in Psoriasis, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

Browse trials for

03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    LY3316531 (Part A)

    Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).

    Drug: LY3316531 - IV · Drug: LY3316531 - SC

  • Placebo comparator
    Placebo (Part A)

    Placebo matching LY3316531 administered IV.

    Drug: Placebo - IV

  • Experimental
    LY3316531 (Part B)

    Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).

    Drug: LY3316531 - IV

  • Placebo comparator
    Placebo (Part B)

    Placebo matching LY3316531 administered IV.

    Drug: Placebo - IV

  • Experimental
    LY3316531 (Part C)

    Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.

    Drug: LY3316531 - IV

Interventions

  • DrugLY3316531 - IV

    Administered IV.

  • DrugLY3316531 - SC

    Administered SC.

  • DrugPlacebo - IV

    Administered IV.

05

What researchers measure

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.

    Time frame: Pre-dose up to 1 year after administration of study drug

Secondary outcomes

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

    PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."

    Time frame: 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

  2. Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

    PK: Cmax of LY3316531 following the Day 57 dose.

    Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85

  3. Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

    PK: Cmax of LY3316531.

    Time frame: 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

  4. Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)

    Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

    Time frame: 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

  5. Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau

    AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.

    Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85

  6. Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)

    Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

    Time frame: 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

06

Results

Posted Sep 21, 2023

Participant flow

Study consists of three parts: * Part A (Single-Ascending Dose (SAD) in healthy participants) * Part B (Multiple-dose in healthy participants) and * Part C (Single dose in psoriasis participants)

Participant flow — Overall Study
MilestonePlacebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part C
Started113366666268
Completed103366666258
Not completed10000000010
Withdrew: Adverse event10000000000
Withdrew: Protocol violation00000000010

Outcome measures

PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.

Time frame:
Pre-dose up to 1 year after administration of study drug
Reported as:
Count of participants · Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
ParticipantsPlacebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part C
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration00000000010
SecondaryPart A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."

Time frame:
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
Reported as:
Geometric mean · micrograms per milliliter (μg/mL)
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
micrograms per milliliter (μg/mL)3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part A
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY33165311.27 ± 189.94 ± 2632.7 ± 22115 ± 1127.2 ± 30453 ± 14808 ± 15
SecondaryPart B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

PK: Cmax of LY3316531 following the Day 57 dose.

Time frame:
Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Reported as:
Geometric mean · μg/mL
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
μg/mL2000 mg LY3316531 IV - Part B
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531876 ± 14
SecondaryPart C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

PK: Cmax of LY3316531.

Time frame:
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
Reported as:
Geometric mean · μg/mL
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
μg/mL300 mg LY3316531 IV - Part C
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531124 ± 19
SecondaryPart A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

Time frame:
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
Reported as:
Geometric mean · micrograms*hours per milliliter(μg*h/mL)
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
micrograms*hours per milliliter(μg*h/mL)3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part A
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)401 ± 73050 ± 2312,700 ± 1946,900 ± 1025,800 ± 27181,000 ± 25319,000 ± 31
SecondaryPart B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau

AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.

Time frame:
Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Reported as:
Geometric mean · μg*h/mL
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
μg*h/mL2000 mg LY3316531 IV - Part B
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau258,000 ± 2
SecondaryPart C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

Time frame:
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
Reported as:
Geometric mean · μg*h/mL
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
μg*h/mL300 mg LY3316531 IV - Part C
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)39,500 ± 28

Adverse events

Collected over Up To 1 Year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo - Part A0/11 (0%)0/11 (0%)5/11 (45.5%)
3 mg LY3316531 IV - Part A0/3 (0%)0/3 (0%)1/3 (33.3%)
15 mg LY3316531 IV - Part A0/3 (0%)0/3 (0%)1/3 (33.3%)
75 mg LY3316531 IV - Part A0/6 (0%)0/6 (0%)1/6 (16.7%)
300 mg LY3316531 IV - Part A0/6 (0%)0/6 (0%)1/6 (16.7%)
300 mg LY3316531 SC- Part A0/6 (0%)0/6 (0%)5/6 (83.3%)
900 mg LY3316531 IV - Part A0/6 (0%)0/6 (0%)2/6 (33.3%)
2000 mg LY3316531 IV - Part A0/6 (0%)0/6 (0%)1/6 (16.7%)
Placebo - Part B0/2 (0%)0/2 (0%)1/2 (50%)
2000 mg LY3316531 IV - Part B0/6 (0%)1/6 (16.7%)4/6 (66.7%)
300 mg LY3316531 IV - Part C0/8 (0%)0/8 (0%)7/8 (87.5%)
Most frequent serious events
Most frequent serious events
EventPlacebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part C
Abscess limbInfections and infestations0/110/30/30/60/60/60/60/60/21/60/8
Most frequent other events
Showing 10 of 36
Most frequent other events
EventPlacebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part C
ConstipationGastrointestinal disorders0/110/30/30/60/60/60/60/61/20/60/8
Upper respiratory tract infectionInfections and infestations0/111/30/30/60/60/60/60/61/20/61/8
Injection site erythemaGeneral disorders0/110/30/30/60/62/60/60/60/20/60/8
LacerationInjury, poisoning and procedural complications0/110/31/30/60/60/60/60/60/20/60/8
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders0/111/30/30/60/60/60/60/60/21/60/8
HeadacheNervous system disorders2/110/30/30/60/60/60/60/60/20/60/8
Chapped lipsGastrointestinal disorders0/110/30/31/60/60/60/60/60/20/60/8
Chest painGeneral disorders0/110/30/30/60/60/61/60/60/20/60/8
Infusion site bruisingGeneral disorders0/110/30/30/60/60/60/60/60/21/60/8
Injection site bruisingGeneral disorders0/110/30/30/60/61/60/60/60/20/60/8

Baseline characteristics

All randomized participants.

Age, Categorical
Age, Categorical(Participants)Placebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part CTotal
<=18 years000000000000
Between 18 and 65 years11336666626863
>=65 years000000000000
Sex: Female, Male
Sex: Female, Male(Participants)Placebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part CTotal
Female4112102111317
Male7224564515546
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part CTotal
Hispanic or Latino2112422210017
Not Hispanic or Latino9224244416846
Unknown or Not Reported000000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part CTotal
American Indian or Alaska Native000000000000
Asian101001000003
Native Hawaiian or Other Pacific Islander000001000001
Black or African American5203102202421
White5123543422334
More than one race000000100214
Unknown or Not Reported000000000000
Region of Enrollment
Region of Enrollment(Participants)Placebo - Part A3 mg LY3316531 IV - Part A15 mg LY3316531 IV - Part A75 mg LY3316531 IV - Part A300 mg LY3316531 IV - Part A300 mg LY3316531 SC- Part A900 mg LY3316531 IV - Part A2000 mg LY3316531 IV - Part APlacebo - Part B2000 mg LY3316531 IV - Part B300 mg LY3316531 IV - Part CTotal
United States11336666626863
07

Study locations

2 sites
  • Parexel Early Phase Unit at Glendale
    Glendale, California 91206-4140, United States
  • PAREXEL-Phase 1 Baltimore Harbor Hospital Center
    Baltimore, Maryland 21225, United States
08

References and documents

Study documents

  • Study protocol · Aug 17, 2018
  • Statistical analysis plan · Jan 31, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03418493
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Jan 30, 2018
Primary completion
Dec 24, 2018
Completion
Jul 29, 2019
Results posted
Sep 21, 2023
Last update
Sep 21, 2023

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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