A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05896527
Last Updated: 2025-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2023-05-02
2024-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo tablets orally twice daily (BID) for 12 weeks.
Placebo
Matching placebo was supplied as tablets to be administered orally.
DC-806 200 mg BID
Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
DC-806
DC-806 was supplied as tablets to be administered orally.
DC-806 400 mg BID
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
DC-806
DC-806 was supplied as tablets to be administered orally.
DC-806 600 mg QD
Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
DC-806
DC-806 was supplied as tablets to be administered orally.
DC-806 800 mg BID
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
DC-806
DC-806 was supplied as tablets to be administered orally.
Interventions
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DC-806
DC-806 was supplied as tablets to be administered orally.
Placebo
Matching placebo was supplied as tablets to be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18 to 40 kg/m2
* All of the following psoriasis criteria:
* Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit
* Stable moderate to severe chronic plaque psoriasis, defined as ≥10% BSA psoriasis involvement, sPGA score of ≥3, and PASI score ≥12 at the Screening and Baseline visits
* Candidate for phototherapy or systemic therapy, as assessed by the Investigator
* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use a highly effective method of contraception during the study and for ≥30 days after the last dose of study drug
* Willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study drug
Exclusion Criteria
* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, medication-induced or medication-exacerbated psoriasis
* History of chronic infections including human immunodeficiency virus (HIV) or viral hepatitis (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\])
* History of active tuberculosis (TB)
* History or evidence of active infection (including but not limited to coronavirus disease 2019 \[COVID-19\] infection) and/or febrile illness within 7 days, serious infections leading to hospitalization and intravenous antibiotic treatment within 90 days, or serious infection requiring antibiotic treatment within 30 days before the first dose of study drug
* History of malignancy or lymphoproliferative disease except resected cutaneous squamous cell or basal cell carcinoma that has been treated without recurrence
* Presence of active suicidal ideation, or positive suicide behavior using the "Baseline/Screening" version of the Columbia Suicide Severity Rating Scale (C-SSRS) and with either of the following criteria:
* History of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) within 5 years before the Screening visit
* Suicidal ideation in the past month before the Screening visit as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Baseline/Screening" version of the C-SSRS
* Participant has experienced primary failure (no response at approved doses after ≥3 months of therapy) to one or more therapeutic agents targeted to IL-17 (including but not limited to secukinumab, ixekizumab, brodalumab, bimekizumab)
* Systemic use of known strong and moderate cytochrome P450 (CYP)3A4 inhibitors or strong CYP3A4 inducers from Screening through the end of the study
* A 12-lead electrocardiogram (ECG) at Screening that demonstrates clinically significant abnormalities or criteria associated with QT interval abnormalities including prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) (\>500 msec)
* Laboratory values meeting the following criteria within the screening period before the first dose of study drug:
* Serum aspartate transaminase ≥2× upper limit of normal (ULN)
* Serum alanine transaminase ≥2×ULN
* Serum total, direct, or indirect bilirubin ≥2.0 mg/dL; except for participants with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome
* Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \<45 mL/min/1.73m2
* Total white blood cell count \<3000/μL
* Absolute neutrophil count \<1500/μL
* Platelet count \<100,000/μL
* Hemoglobin \<9 g/dL
* In the opinion of the Investigator or Sponsor, have any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the participant's enrollment in the study
18 Years
70 Years
ALL
No
Sponsors
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DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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First OC Dermatology
Fountain Valley, California, United States
Clinical Science Institute
Santa Monica, California, United States
Driven Research LLC
Coral Gables, Florida, United States
Kirsch Dermatology - Probity - PPDS
Naples, Florida, United States
GCP Global Clinical Professionals, LLC
St. Petersburg, Florida, United States
ForCare Clinical Research - CenExel FCR - PPDS
Tampa, Florida, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Dermatology Specialists Research - 501 S 2nd St
Louisville, Kentucky, United States
DICE Therapeutics Study Site
New York, New York, United States
Dermatologists of Southwest Ohio - Probity - PPDS
Mason, Ohio, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
Center for Clinical Studies - Webster
Webster, Texas, United States
Virginia Clinical Research Inc
Norfolk, Virginia, United States
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, Canada
Enverus Medical Research - Probity - PPDS
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba, Canada
CCA Medical Research - Probity - PPDS
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
Lynderm Research Inc. - Probity - PPDS
Markham, Ontario, Canada
DermEdge Research Probity - PPDS
Mississauga, Ontario, Canada
DICE Therapeutics Study Site
North York, Ontario, Canada
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, , Canada
Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
Prague, Praha, Hlavní Mesto, Czechia
CCR Prague s.r.o. - PRATIA - PPDS
Prague, Praha, Hlavní Mesto, Czechia
CCR Prague s.r.o. - PRATIA - PPDS
Prague, , Czechia
DICE Therapeutics Study Site
Prague, , Czechia
DICE Therapeutics Study Site
Erlangen, Bavaria, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
DICE Therapeutics Study Site
Bonn, North Rhine-Westphalia, Germany
DICE Therapeutics Study Site
Münster, North Rhine-Westphalia, Germany
DICE Therapeutics Study Site
Leipzig, Saxony, Germany
DICE Therapeutics Study Site
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
DICE Therapeutics Study Site
Lübeck, , Germany
DICE Therapeutics Study Site
Tübingen, , Germany
Allergo-Derm Bakos Kft.
Szolnok, Jász-Nagykun-Szolnok, Hungary
DICE Therapeutics Study Site
Kaposvár, Somogy County, Hungary
DICE Therapeutics Study Site
Szombathely, Vas County, Hungary
Semmelweis Egyetem
Budapest, , Hungary
DICE Therapeutics Study Site
Gyöngyös, , Hungary
MedMare Bt
Veszprém, , Hungary
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Lower Silesian Voivodeship, Poland
Wro Medica
Wroclaw, Lower Silesian Voivodeship, Poland
Dermoklinika-Centrum Medyczne s.c
Lódz, Lódzkie, Poland
Centrum Medyczne Reuma Park NZOZ
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Laser Clinic S.C.
Szczecin, West Pomeranian Voivodeship, Poland
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, , Spain
Synexus Merseyside Clinical Research Centre
Liverpool, Lancashire, United Kingdom
Medicines Evaluation Unit
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-502249-90-00
Identifier Type: OTHER
Identifier Source: secondary_id
J5B-MC-FHAG
Identifier Type: OTHER
Identifier Source: secondary_id
DCE806201
Identifier Type: -
Identifier Source: org_study_id
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