ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-15

Among 35 studies in Psoriasis by Eli Lilly and Company — 1 open to participants now, 1 under way, none of them phase 3. Psoriasis · Eli Lilly and Company.

Enrollment
23rd of 35
63 · median 162
Started
2018
with 5 others
Phase 1
9 of 35
none open now
Registered
21st of 35
by date

Among the 35 studies in Psoriasis by Eli Lilly and Company, this one is the 23rd largest by enrollment, is one of 6 that started in 2018, is one of 9 in phase 1, and was the 21st registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 276 are open to participants now.

Browse Psoriasis studies →

Open to participants now

1 of the 35 studies in Psoriasis by Eli Lilly and Company is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 173 Psoriasis studies recruiting now, 91 (53%) set no upper age limit and 66 (38%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 64 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Psoriasis by Eli Lilly and Company, or all of them as a file.
02

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.

03

Conditions studied

  • Psoriasis

Browse trials for

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy Participants

    • Are overtly healthy males or females, as determined by medical history and physical examination
    • Females must be of non-
    • Are between 18 and 64 years of age, inclusive, at screening
    • Have a 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 (s) (included attenuated live vaccines) within 28 days of screening or intend to during the study
    • Have had any 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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.

06

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

07

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
08

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
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2018, 10 months.

Results were first posted in Sep 2023, 4 years 8 months after primary completion.

Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 10 months is close to that.

Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Jan 30, 2018
Primary completionActual
Dec 24, 2018
CompletionActual
Jul 29, 2019
Results first posted
Sep 21, 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03418493
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
View the source record on ClinicalTrials.gov ↗

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