Evaluating LY4100511 for treating moderate-to-severe plaque psoriasis in adults
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
This study is testing a new treatment called LY4100511 to see if it can help adults with moderate-to-severe plaque psoriasis feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 58 sites (Birmingham, Alabama and 57 other locations) |
| Trial ID | NCT06602219 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of LY4100511, a new treatment, in adults suffering from moderate-to-severe plaque psoriasis. Participants will be randomly assigned to receive either the active treatment or a placebo. The study will monitor participants for any adverse effects and measure improvements in their psoriasis symptoms over time. The goal is to determine if LY4100511 can provide a better treatment option for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate-to-severe plaque psoriasis for at least six months and who meet specific health criteria.
Not a fit: Patients with certain types of psoriasis or those who have had recent significant flare-ups may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer significant relief and improved quality of life for patients with moderate-to-severe plaque psoriasis.
How similar studies have performed: Other studies have shown promise with similar treatments for plaque psoriasis, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Birmingham, Alabama and 57 other locations
- Cahaba Dermatology Skin Health Center — Birmingham, Alabama, United States (Recruiting)
- Dermatology Trial Associates — Bryant, Arkansas, United States (Recruiting)
- Zenith Research, Inc. — Beverly Hills, California, United States (Not_yet_recruiting)
- First OC Dermatology Research Inc — Fountain Valley, California, United States (Recruiting)
- Center for Dermatology Clinical Research — Fremont, California, United States (Recruiting)
- Dermatology Research Associates — Los Angeles, California, United States (Recruiting)
- Clinical Science Institute — Santa Monica, California, United States (Recruiting)
- Driven Research — Coral Gables, Florida, United States (Recruiting)
- Direct Helpers Research Center — Hialeah, Florida, United States (Recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Not_yet_recruiting)
- GCP Global Clinical Professionals, LLC — Saint Petersburg, Florida, United States (Recruiting)
- ForCare Clinical Research — Tampa, Florida, United States (Recruiting)
- Endeavor Clinical Trials Center - Dermatology - Skokie — Skokie, Illinois, United States (Not_yet_recruiting)
- Lawrence J Green, M.D, LLC — Rockville, Maryland, United States (Recruiting)
- Center for Clinical Studies, LTD.LLP — Webster, Texas, United States (Recruiting)
- Interior Dermatology Centre - Probity - PPDS — Kelowna, British Columbia, Canada (Recruiting)
- Skin Care West — Nanaimo, British Columbia, Canada (Recruiting)
- Simcoderm Medical & Surgical Dermatology Centre — Barrie, Ontario, Canada (Recruiting)
- Dermatrials Research Inc. — Hamilton, Ontario, Canada (Recruiting)
- Lovegrove Dermatology - Probity - PPDS — London, Ontario, Canada (Recruiting)
- DermEffects - Probity - PPDS — London, Ontario, Canada (Recruiting)
- Lynderm Research Inc. — Markham, Ontario, Canada (Recruiting)
- DermEdge Research — Mississauga, Ontario, Canada (Recruiting)
- Clintrial s.r.o. — Praha, Praha 10, Czechia (Recruiting)
- Pratia Pardubice a.s. - PRATIA - PPDS — Pardubice, Czechia (Recruiting)
- Fakultni nemocnice Kralovske Vinohrady — Praha 10, Czechia (Recruiting)
- Pratia Prague s.r.o. - PRATIA - PPDS — Praha 3, Czechia (Recruiting)
- Kozni ambulance Fialova, s.r.o. - CRC - PPDS — Praha, Czechia (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Baden-Württemberg, Germany (Recruiting)
- Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD — Augsburg, Bayern, Germany (Recruiting)
- Universitätsklinikum Frankfurt — Frankfurt, Hessen, Germany (Recruiting)
- Universitätsklinikum Münster — Münster, Nordrhein-Westfalen, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus an der TU — Dresden, Germany (Recruiting)
- MensingDerma Research GmbH — Hamburg, Germany (Recruiting)
- Debreceni Egyetem Klinikai Kozpont — Debrecen, Bihar, Hungary (Recruiting)
- Allergo-Derm Bakos Kft — Szolnok, Jász-Nagykun-Szolnok, Hungary (Recruiting)
- Gyongyosi Bugat Pal Korhaz — Gyöngyös, Hungary (Recruiting)
- MedMare Bt — Veszprém, Hungary (Recruiting)
- Nagoya City University Hospital — Nagoya, Aichi, Japan (Active_not_recruiting)
- Medical Corporation Kojinkai Sapporo Skin Clinic — Sapporo shi, Hakkaido, Japan (Active_not_recruiting)
- Katahira Dermatology Urology Clinic — Kagoshima City, Kagoshima, Japan (Active_not_recruiting)
- Ohyama Dermatology Clinic — Kumamoto-shi, Kumamoto, Japan (Active_not_recruiting)
- Kume Clinic — Sakai-shi, Osaka, Japan (Active_not_recruiting)
- Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, Japan (Active_not_recruiting)
- Tachikawa Dermatology Clinic — Tachikawa, Tokyo, Japan (Active_not_recruiting)
- Shirasaki dermatology clinic — Takaoka, Toyama, Japan (Active_not_recruiting)
- Igarashi Dermatological Clinic — Tokyo, Japan (Active_not_recruiting)
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu — Wroclaw, Dolnoslaskie, Poland (Recruiting)
- Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska — Wroclaw, Dolnoslaskie, Poland (Recruiting)
- Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak — Lodz, Lodzkie, Poland (Recruiting)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 3176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.