Plaque PsoriasisPhase 2NCT06602219
A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing LY4100511 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 58 sites in 7 countries.
Trial summary
The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- LY4100511
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 58 sitesin 7 countries
- Study dates
- 25 Oct 2024to 4 Sep 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
- Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
- Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
- Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study
Who cannot join
- Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
- Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
- Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
- Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
- Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.
Trial locations and contacts
58 sites in 7 countries.
58 sites in 7 countries
United States15 sites
Zenith Research, Inc.
Beverly Hills, California, 90212
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244
Dermatology Trial Associates
Bryant, Arkansas, 72022
Driven Research
Coral Gables, Florida, 33134
First OC Dermatology Research Inc
Fountain Valley, California, 92708
Center for Dermatology Clinical Research
Fremont, California, 94538-1614
Direct Helpers Research Center
Hialeah, Florida, 33012
Dermatology Research Associates
Los Angeles, California, 90045
Renstar Medical Research
Ocala, Florida, 34470
Lawrence J Green, M.D, LLC
Rockville, Maryland, 20850
Clinical Science Institute
Santa Monica, California, 90404
Endeavor Clinical Trials Center - Dermatology - Skokie
Skokie, Illinois, 60077-1049
GCP Global Clinical Professionals, LLC
St. Petersburg, Florida, 33713-8012
ForCare Clinical Research
Tampa, Florida, 33613
Center for Clinical Studies, LTD.LLP
Webster, Texas, 77598
Poland11 sites
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, 42-202
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537
Centrum Medyczne Angelius Provita
Katowice, 40-611
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Łódź Voivodeship, 90-436
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, 35-055
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
Szczecin, West Pomeranian Voivodeship, 70-332
Clinical Best Solutions
Warsaw, Masovian Voivodeship, 00-710
Centrum Medyczne Reuma Park NZOZ
Warsaw, 02-665
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566
Japan9 sites
Katahira Dermatology Urology Clinic
Kagoshima, Kagoshima-ken, 890-0063
Ohyama Dermatology Clinic
Kumamoto, Kumamoto, 861-4101
Nagoya City University Hospital
Nagoya, Aichi-ken, 450-0003
Kume Clinic
Sakai-shi, Osaka, 593-8324
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hakkaido, 060-0063
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Tachikawa Dermatology Clinic
Tachikawa, Tokyo, 190-0023
Shirasaki dermatology clinic
Takaoka, Toyama, 933-0871
Igarashi Dermatological Clinic
Tokyo
Canada8 sites
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Dermatrials Research Inc.
Hamilton, Ontario, L8N 1Y2
Interior Dermatology Centre - Probity - PPDS
Kelowna, British Columbia, V1W 4V5
Lovegrove Dermatology - Probity - PPDS
London, Ontario, N6A 5R9
DermEffects - Probity - PPDS
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Skin Care West
Nanaimo, British Columbia, V9T1W1
Germany6 sites
Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
Augsburg, Bavaria, 86150
Universitätsklinikum Carl Gustav Carus an der TU
Dresden, 1307
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
MensingDerma Research GmbH
Hamburg, 22391
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Czechia5 sites
Pratia Pardubice a.s. - PRATIA - PPDS
Pardubice, 530 02
Clintrial s.r.o.
Prague, Praha 10, 10100
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Pratia Prague s.r.o. - PRATIA - PPDS
Prague, 13000
Kozni ambulance Fialova, s.r.o. - CRC - PPDS
Prague, 160 00
Hungary4 sites
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032
Gyongyosi Bugat Pal Korhaz
Gyöngyös, 3200
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000
MedMare Bt
Veszprém, 8200
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants With Moderate-to Severe Plaque Psoriasis
The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- LY4100511, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4100511Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4100511 200 mg BID | Experimental | Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks. Receives: Drug: LY4100511 |
| LY4100511 400 mg BID | Experimental | Participants received LY4100511 400 mg administered orally BID for 12 weeks. Receives: Drug: LY4100511 |
| LY4100511 800 mg QD | Experimental | Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening. Receives: Drug: LY4100511 |
| Placebo BID | Placebo comparator | Participants received placebo administered orally BID for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Secondary outcomes (13)
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe):
- 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur
- 1 = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling
- 2 = Mild: Pink to light red color; slight thickening; mainly fine scaling
- 3 = Moderate: Dull bright red erythema; moderate thickening; moderate scaling
- 4 = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions
Measured: Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Week 12
Change From Baseline in PASI Score at Week 12
Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12
Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Measured: Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.
BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.
BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.
Measured: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
Ctrough,ss of LY4100511
Measured: Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511.
A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit.
A serious adverse event (SAE) is any untoward medical occurrence at any dose that:
- Results in death
- Is life-threatening (risk of death at the time of the event)
- Requires inpatient hospitalization or prolongation of existing hospitalization (excluding elective admission for a stable pre-existing condition)
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Other medically important event that may jeopardize the participant or require intervention to prevent the above outcomes
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Oct 2024
- Primary completion24 Jul 2025
- Study completion4 Sep 2025
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 Plaque PsoriasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of 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
- NCT06602219
- Sponsor's protocol ID
- 18845
- Other IDs
- J5C-MC-FOAB
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2024
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants With Moderate-to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06602219
- Acronym / sponsor ID
- 18845
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY4100511 200 mg BID | Experimental | Drug: LY4100511Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks. |
| LY4100511 400 mg BID | Experimental | Drug: LY4100511Participants received LY4100511 400 mg administered orally BID for 12 weeks. |
| LY4100511 800 mg QD | Experimental | Drug: LY4100511Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening. |
| Placebo BID | Placebo comparator | Drug: PlaceboParticipants received placebo administered orally BID for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
- Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
- Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
- Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study
Key exclusion criteria (5 listed)
- Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
- Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
- Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
- Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
- Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/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 |
|---|---|---|
| LY4100511Administered orally | Drug | LY4100511 200 mg BID, LY4100511 400 mg BID, LY4100511 800 mg QD |
| PlaceboAdministered orally | Drug | Placebo BID |
Primary outcome
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Time frame: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
13 secondary outcomes
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
Time frame: Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
Time frame: Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
Time frame: Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Time frame: Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
Time frame: Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
Time frame: Week 12
Change From Baseline in PASI Score at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Time frame: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
Time frame: Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
Time frame: Baseline up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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
58 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY4100511 in people with Plaque Psoriasis, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 58 sites in 7 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 4 inclusion and 5 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Poland, Japan, Canada, Germany and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Aug 2026). 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?
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo) (time frame: Week 12). 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 18 Aug 2026.