Clinical trial NCT06602219: A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline
timeFrame: Week 12
measure: Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50)
timeFrame: Week 12
measure: Percentage of Participants Achieving ≥75% Reduction in PASI score (PASI 75)
timeFrame: Week 12
measure: Percentage of Participants Achieving ≥90% Reduction in PASI score (PASI 90)
timeFrame: Week 12
measure: Percentage of Participants Achieving 100% Reduction in PASI score (PASI 100)
timeFrame: Week 12
measure: Percentage of Participants Achieving an sPGA Score of 0 or 1
timeFrame: Week 12
measure: Mean Change from Baseline in PASI Score
timeFrame: Week 12
measure: Percent Change from Baseline in PASI Score
timeFrame: Week 12
measure: Mean Change from Baseline in the Percentage of BSA Affected
timeFrame: Week 12
measure: Percent Change from Baseline in the Percentage of BSA affected
timeFrame: Week 12
measure: Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
timeFrame: Predose up to 84 Days
measure: PK: Steady State Trough Concentration (Ctrough,ss)
timeFrame: Predose up to 84 Days
measure: 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
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology Skin Health Center
state: Alabama
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Beverly Hills
country: United States
facility: Zenith Research, Inc.
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Skokie
country: United States
facility: Endeavor Clinical Trials Center - Dermatology - Skokie
state: Illinois
city: Rockville
country: United States
facility: Lawrence J Green, M.D, LLC
state: Maryland
city: Webster
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Kelowna
country: Canada
facility: Interior Dermatology Centre - Probity - PPDS
state: British Columbia
city: Nanaimo
country: Canada
facility: Skin Care West
state: British Columbia
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Inc.
state: Ontario
city: London
country: Canada
facility: Lovegrove Dermatology - Probity - PPDS
state: Ontario
city: London
country: Canada
facility: DermEffects - Probity - PPDS
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Praha
country: Czechia
facility: Clintrial s.r.o.
state: Praha 10
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s. - PRATIA - PPDS
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 3
country: Czechia
facility: Pratia Prague s.r.o. - PRATIA - PPDS
city: Praha
country: Czechia
facility: Kozni ambulance Fialova, s.r.o. - CRC - PPDS
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU
city: Hamburg
country: Germany
facility: MensingDerma Research GmbH
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: Bihar
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jász-Nagykun-Szolnok
city: Gyöngyös
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz
city: Veszprém
country: Hungary
facility: MedMare Bt
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sapporo shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Skin Clinic
state: Hakkaido
city: Kagoshima City
country: Japan
facility: Katahira Dermatology Urology Clinic
state: Kagoshima
city: Kumamoto-shi
country: Japan
facility: Ohyama Dermatology Clinic
state: Kumamoto
city: Sakai-shi
country: Japan
facility: Kume Clinic
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Tachikawa
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Takaoka
country: Japan
facility: Shirasaki dermatology clinic
state: Toyama
city: Tokyo
country: Japan
facility: Igarashi Dermatological Clinic
city: Wroclaw
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
state: Lodzkie
city: Warszawa
country: Poland
facility: Clinical Best Solutions
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
state: Podkarpackie
city: Gdańsk
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
state: Pomorskie
city: Gdynia
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Szczecin
country: Poland
facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park NZOZ
city: Częstochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
state: Śląskie
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: