PsoriasisPhase 1NCT04152382
A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis
A Phase 1 study testing LY3462817 - IV, LY3462817 - SC and LY3509754 in people with Psoriasis, run by Eli Lilly and Company at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- LY3462817 - IV, LY3462817 - SC and LY3509754
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 20 Nov 2019to 9 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Meridian Clinical Research
Baton Rouge, Louisiana, 70808
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201
Dermatology Associates - Los Angeles
Los Angeles, California, 90045
Miami Dermatology and Laser Research
Miami, Florida, 33173
Advanced Pharma Clinical Research
Miami, Florida, 33175
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
ForCare Clinical Research
Tampa, Florida, 33613-1244
Avita Clinical Research
Tampa, Florida, 33613
Canada3 sites
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Skin Health
Cobourg, Ontario, K9A 0Z4
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
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.
- Conditions
- Psoriasis
- Being tested
- LY3462817 - IV, LY3462817 - SC, Placebo - IV, Placebo - SC, LY3509754
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3462817 - IVDrug
Administered IV
LY3462817 - SCDrug
Administered SC
Placebo - IVDrug
Administered IV
Placebo - SCDrug
Administered SC
LY3509754Drug
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3462817 - Intravenous (IV) | Experimental | LY3462817 administered as IV infusions. Receives: Drug: LY3462817 - IV |
| Placebo - IV | Placebo comparator | Placebo administered as IV infusions. Receives: Drug: Placebo - IV |
| LY3462817 - Subcutaneous (SC) | Experimental | LY3462817 administered as SC injections. (SC administration is discretionary/optional.) Receives: Drug: LY3462817 - SC |
| Placebo - SC | Placebo comparator | Placebo administered as SC injections. (SC administration is discretionary/optional.) Receives: Drug: Placebo - SC |
| LY3509754 | Experimental | LY3509754 administered orally. Receives: Drug: LY3509754 |
| Placebo | Placebo comparator | Placebo administered orally. Receives: Drug: Placebo |
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 LY3462817 and LY3509754
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Secondary outcomes (1)
Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
PK: Cave of LY3462817 and LY3509754
Measured: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start20 Nov 2019
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Why it stopped: Terminated due to liver findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152382
- Sponsor's protocol ID
- 17218
- Other IDs
- J1A-MC-KDAC
- Status last verified
- Feb 2022
- First submitted
- 4 Nov 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT04152382
- Acronym / sponsor ID
- 17218
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to liver findings
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3462817 - Intravenous (IV) | Experimental | Drug: LY3462817 - IVLY3462817 administered as IV infusions. |
| Placebo - IV | Placebo comparator | Drug: Placebo - IVPlacebo administered as IV infusions. |
| LY3462817 - Subcutaneous (SC) | Experimental | Drug: LY3462817 - SCLY3462817 administered as SC injections. (SC administration is discretionary/optional.) |
| Placebo - SC | Placebo comparator | Drug: Placebo - SCPlacebo administered as SC injections. (SC administration is discretionary/optional.) |
| LY3509754 | Experimental | Drug: LY3509754LY3509754 administered orally. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| LY3462817 - IVAdministered IV | Drug | LY3462817 - Intravenous (IV) |
| LY3462817 - SCAdministered SC | Drug | LY3462817 - Subcutaneous (SC) |
| Placebo - IVAdministered IV | Drug | Placebo - IV |
| Placebo - SCAdministered SC | Drug | Placebo - SC |
| LY3509754Administered orally. | Drug | LY3509754 |
| PlaceboAdministered orally. | Drug | Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754
Time frame: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
1 secondary outcome
Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
Time frame: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Results and safety
The study was stopped early (reason given: Terminated due to liver findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- A Safety Study of LY3462817 in Participants With PsoriasisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3462817 - IV, LY3462817 - SC and LY3509754 in people with Psoriasis, run by Eli Lilly and Company at 13 sites in 2 countries.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
The study was stopped early (reason given: Terminated due to liver findings). Results are not available in the source record.
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 LY3462817 and LY3509754 (time frame: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.