PsoriasisPhase 1NCT03418493

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

A Phase 1 study testing LY3316531 - IV and LY3316531 - SC in people with Psoriasis, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Psoriasis
What is being tested?: LY3316531 - IV and LY3316531 - SC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 2 sitesUnited States
Study dates: 30 Jan 2018to 29 Jul 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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)

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225
Parexel Early Phase Unit at Glendale
Glendale, California, 91206-4140

Other trials in United States

About this study

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

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.

Conditions: Psoriasis
Being tested: LY3316531 - IV, LY3316531 - SC, Placebo - IV
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3316531 - IVDrug
Administered IV.
LY3316531 - SCDrug
Administered SC.
Placebo - IVDrug
Administered IV.

Study groups in NCT03418493
Study group	Role	What they receive
LY3316531 (Part A)	Experimental	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). Receives: Drug: LY3316531 - IV; Drug: LY3316531 - SC
Placebo (Part A)	Placebo comparator	Placebo matching LY3316531 administered IV. Receives: Drug: Placebo - IV
LY3316531 (Part B)	Experimental	Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks). Receives: Drug: LY3316531 - IV
Placebo (Part B)	Placebo comparator	Placebo matching LY3316531 administered IV. Receives: Drug: Placebo - IV
LY3316531 (Part C)	Experimental	Participants with psoriasis received single doses of 300 mg LY3316531 administered IV. Receives: Drug: LY3316531 - IV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre-dose up to 1 year after administration of study drug

Secondary outcomes (6)

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."
Measured: 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
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531 following the Day 57 dose.
Measured: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531.
Measured: 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
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-∞).
Measured: 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
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.
Measured: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
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-∞).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201829 Jul 2019

First posted1 Feb 2018
Study start30 Jan 2018
Primary completion24 Dec 2018
Study completion29 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03418493
Sponsor's protocol ID: 16666
Other IDs: I9H-MC-FFAA
Status last verified: 1 Nov 2022
First submitted: 26 Jan 2018
Last updated: 21 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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RecruitingPhase 1
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03418493
Acronym / sponsor ID: 16666
Conditions: Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 30 Jan 2018 (actual)
Primary completion: 24 Dec 2018 (actual)
Study completion: 29 Jul 2019 (actual)
First posted: 1 Feb 2018 (actual)
Results: Posted 21 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY3316531 (Part A)	Experimental	Drug: LY3316531 - IV, Drug: LY3316531 - SCParticipants 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).
Placebo (Part A)	Placebo comparator	Drug: Placebo - IVPlacebo matching LY3316531 administered IV.
LY3316531 (Part B)	Experimental	Drug: LY3316531 - IVParticipants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
Placebo (Part B)	Placebo comparator	Drug: Placebo - IVPlacebo matching LY3316531 administered IV.
LY3316531 (Part C)	Experimental	Drug: LY3316531 - IVParticipants with psoriasis received single doses of 300 mg LY3316531 administered IV.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy Participants
Psoriasis Participants:

Key exclusion criteria (11 listed)

Healthy and Psoriasis Participants
Psoriasis Participants Only:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3316531 - IVAdministered IV.	Drug	LY3316531 (Part A), LY3316531 (Part B), LY3316531 (Part C)
LY3316531 - SCAdministered SC.	Drug	LY3316531 (Part A)
Placebo - IVAdministered IV.	Drug	Placebo (Part A), Placebo (Part B)

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Pre-dose up to 1 year after administration of study drug
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.

6 secondary outcomes

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
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
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: Pharmacokinetics (PK): Maximum Concentration (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
Part A: PK: 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
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: PK: 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

Results and safety

Results posted to the registry on 21 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Part A	11	10
3 mg LY3316531 IV - Part A	3	3
15 mg LY3316531 IV - Part A	3	3
75 mg LY3316531 IV - Part A	6	6
300 mg LY3316531 IV - Part A	6	6
300 mg LY3316531 SC- Part A	6	6
900 mg LY3316531 IV - Part A	6	6
2000 mg LY3316531 IV - Part A	6	6
Placebo - Part B	2	2
2000 mg LY3316531 IV - Part B	6	5
300 mg LY3316531 IV - Part C	8	8

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

Time frame: Pre-dose up to 1 year after administration of study drug. Count of participants. Unit: Participants

Measure	Placebo - Part A n = 11	3 mg LY3316531 IV - Part A n = 3	15 mg LY3316531 IV - Part A n = 3	75 mg LY3316531 IV - Part A n = 6	300 mg LY3316531 IV - Part A n = 6	300 mg LY3316531 SC- Part A n = 6	900 mg LY3316531 IV - Part A n = 6	2000 mg LY3316531 IV - Part A n = 6	Placebo - Part B n = 2	2000 mg LY3316531 IV - Part B n = 6	300 mg LY3316531 IV - Part C n = 8
Value	0	0	0	0	0	0	0	0	0	1	0

Population analysed: All randomized participants who received study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 1 Year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Part A	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
3 mg LY3316531 IV - Part A	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
15 mg LY3316531 IV - Part A	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
75 mg LY3316531 IV - Part A	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
300 mg LY3316531 IV - Part A	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
300 mg LY3316531 SC- Part A	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
900 mg LY3316531 IV - Part A	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
2000 mg LY3316531 IV - Part A	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Placebo - Part B	0 of 2 (0%)	1 of 2 (50%)	0 of 2
2000 mg LY3316531 IV - Part B	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
300 mg LY3316531 IV - Part C	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of LY3316531 in Healthy Participants and in Participants With PsoriasisLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Psoriasis

Not yet recruitingPhase 2
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3316531 - IV and LY3316531 - SC in people with Psoriasis, run by Eli Lilly and Company at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Pre-dose up to 1 year after administration of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03418493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.