A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis
- Registration Number
- NCT06602219
- Lead Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered orally. LY4100511 Dose 1 LY4100511 Participants will receive LY4100511 orally. LY4100511 Dose 2 LY4100511 Participants will receive LY4100511 orally. LY4100511 Dose 3 LY4100511 Participants will receive LY4100511 orally.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Week 12
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline Week 12 Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50) Week 12 Percentage of Participants Achieving ≥75% Reduction in PASI score (PASI 75) Week 12 Percentage of Participants Achieving ≥90% Reduction in PASI score (PASI 90) Week 12 Percentage of Participants Achieving 100% Reduction in PASI score (PASI 100) Week 12 Percentage of Participants Achieving an sPGA Score of 0 or 1 Week 12 Mean Change from Baseline in PASI Score Week 12 Percent Change from Baseline in PASI Score Week 12 Mean Change from Baseline in the Percentage of BSA Affected Week 12 Percent Change from Baseline in the Percentage of BSA affected Week 12 Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss) Predose up to 84 Days PK: Steady State Trough Concentration (Ctrough,ss) Predose up to 84 Days Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the by the investigator to be related to study drug administration Baseline to Week 12 A summary of AEs, SAEs and other non- serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events Module.
Trial Locations
- Locations (58)
Simcoderm Medical & Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
Pratia Pardubice a.s. - PRATIA - PPDS
🇨🇿Pardubice, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum Carl Gustav Carus an der TU
🇩🇪Dresden, Germany
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Bihar, Hungary
Gyongyosi Bugat Pal Korhaz
🇭🇺Gyöngyös, Hungary
Centrum Medyczne Reuma Park NZOZ
🇵🇱Warszawa, Poland
Cahaba Dermatology Skin Health Center
🇺🇸Birmingham, Alabama, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Zenith Research, Inc.
🇺🇸Beverly Hills, California, United States
First OC Dermatology Research Inc
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Driven Research
🇺🇸Coral Gables, Florida, United States
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
GCP Global Clinical Professionals, LLC
🇺🇸Saint Petersburg, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Endeavor Clinical Trials Center - Dermatology - Skokie
🇺🇸Skokie, Illinois, United States
Lawrence J Green, M.D, LLC
🇺🇸Rockville, Maryland, United States
Center for Clinical Studies, LTD.LLP
🇺🇸Webster, Texas, United States
Interior Dermatology Centre - Probity - PPDS
🇨🇦Kelowna, British Columbia, Canada
Skin Care West
🇨🇦Nanaimo, British Columbia, Canada
Dermatrials Research Inc.
🇨🇦Hamilton, Ontario, Canada
Lovegrove Dermatology - Probity - PPDS
🇨🇦London, Ontario, Canada
DermEffects - Probity - PPDS
🇨🇦London, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
Clintrial s.r.o.
🇨🇿Praha, Praha 10, Czechia
Pratia Prague s.r.o. - PRATIA - PPDS
🇨🇿Praha 3, Czechia
Kozni ambulance Fialova, s.r.o. - CRC - PPDS
🇨🇿Praha, Czechia
Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
🇩🇪Augsburg, Bayern, Germany
MensingDerma Research GmbH
🇩🇪Hamburg, Germany
Allergo-Derm Bakos Kft
🇭🇺Szolnok, Jász-Nagykun-Szolnok, Hungary
MedMare Bt
🇭🇺Veszprém, Hungary
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
🇯🇵Sapporo-shi, Hakkaido, Japan
Katahira Dermatology Urology Clinic
🇯🇵Kagoshima City, Kagoshima, Japan
Ohyama Dermatology Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Kume Clinic
🇯🇵Sakai-shi, Osaka, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tachikawa Dermatology Clinic
🇯🇵Tachikawa, Tokyo, Japan
Shirasaki dermatology clinic
🇯🇵Takaoka, Toyama, Japan
Igarashi Dermatological Clinic
🇯🇵Tokyo, Japan
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wroclaw, Dolnoslaskie, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
🇵🇱Wroclaw, Dolnoslaskie, Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
🇵🇱Lodz, Lodzkie, Poland
Clinical Best Solutions
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
🇵🇱Rzeszów, Podkarpackie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdańsk, Pomorskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱Gdynia, Pomorskie, Poland
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
🇵🇱Szczecin, Zachodniopomorskie, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
🇵🇱Częstochowa, Śląskie, Poland