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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05896527
Other study ID # DCE806201
Secondary ID 2022-502249-90-0
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 11, 2023
Est. completion date March 31, 2024

Study information

Verified date December 2023
Source DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 229
Est. completion date March 31, 2024
Est. primary completion date February 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: - Male or female, 18 to 70 years of age - 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 Key Exclusion Criteria: - Have had a clinically significant flare of psoriasis during the 12 weeks before the Baseline visit, as assessed by the Investigator - 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 within the last 5 years 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DC-806
DC-806 will be supplied as tablets to be administered orally.
Other:
Placebo
Matching placebo will be supplied as tablets to be administered orally.

Locations

Country Name City State
Canada CCA Medical Research - Probity - PPDS Ajax Ontario
Canada SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS Barrie Ontario
Canada Kirk Barber Research Calgary Alberta
Canada Alberta DermaSurgery Centre - Probity - PPDS Edmonton Alberta
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 Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) Quebec
Canada Enverus Medical Research - Probity - PPDS Surrey British Columbia
Canada Alliance Clinical Trials - Probity - PPDS Waterloo Ontario
Canada Wiseman Dermatology Research Inc. - Probity - PPDS Winnipeg Manitoba
Czechia CCR Prague s.r.o. - PRATIA - PPDS Praha Praha, Hlavní Mesto
Czechia Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS Praha Praha, Hlavní Mesto
Czechia CCR Prague s.r.o. - PRATIA - PPDS Praha 10
Czechia DICE Therapeutics Study Site Praha 5
Germany DICE Therapeutics Study Site Berlin
Germany ISA - Interdisciplinary Study Association GmbH Berlin
Germany DICE Therapeutics Study Site Bonn Nordrhein-Westfalen
Germany Universitätsklinikum Carl Gustav Carus an der TU Dresden Dresden Sachsen
Germany DICE Therapeutics Study Site Erlangen Bayern
Germany Universitätsklinikum Frankfurt Frankfurt am Main Hessen
Germany DICE Therapeutics Study Site Leipzig Sachsen
Germany DICE Therapeutics Study Site Lübeck
Germany DICE Therapeutics Study Site Münster Nordrhein-Westfalen
Germany DICE Therapeutics Study Site Tübingen
Hungary Semmelweis Egyetem Budapest
Hungary DICE Therapeutics Study Site Gyöngyös
Hungary DICE Therapeutics Study Site Kaposvár Somogy
Hungary Allergo-Derm Bakos Kft. Szolnok Jász-Nagykun-Szolnok
Hungary DICE Therapeutics Study Site Szombathely Vas
Hungary MedMare Bt Veszprém
Poland ClinicMed Daniluk, Nowak Spólka Komandytowa Bialystok Podlaskie
Poland Centrum Medyczne Angelius Provita Katowice Slaskie
Poland Dermoklinika-Centrum Medyczne s.c Lódz Lódzkie
Poland Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie Rzeszów Podkarpackie
Poland Laser Clinic S.C. Szczecin Zachodniopomorskie
Poland Centrum Medyczne Reuma Park NZOZ Warszawa Mazowieckie
Poland Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Wroclaw Dolnoslaskie
Poland Wro Medica Wroclaw Dolnoslaskie
Spain Hospital de La Santa Creu i Sant Pau Barcelona
Spain 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
United Kingdom AES - DRS -NW Consortium Lancashire Chorley Lancashire
United Kingdom Synexus Merseyside Clinical Research Centre Liverpool Lancashire
United Kingdom Medicines Evaluation Unit Manchester
United States Driven Research LLC Coral Gables Florida
United States First OC Dermatology Fountain Valley California
United States Dawes Fretzin Clinical Research Group LLC Indianapolis Indiana
United States Dermatology Specialists Research - 501 S 2nd St Louisville Kentucky
United States Dermatologists of Southwest Ohio - Probity - PPDS Mason Ohio
United States Kirsch Dermatology - Probity - PPDS Naples Florida
United States DICE Therapeutics Study Site New York New York
United States Virginia Clinical Research Inc Norfolk Virginia
United States Paddington Testing Company Inc Philadelphia Pennsylvania
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States ALLCUTIS Research, LLC. Portsmouth New Hampshire
United States Northwest Arkansas Clinical Trials Center PLLC Rogers Arkansas
United States GCP Global Clinical Professionals, LLC Saint Petersburg Florida
United States Clinical Science Institute Santa Monica California
United States ForCare Clinical Research - CenExel FCR - PPDS Tampa Florida
United States Center for Clinical Studies - Webster Webster Texas

Sponsors (1)

Lead Sponsor Collaborator
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants achieving =75% reduction in Psoriasis Area of Severity Index score (PASI-75) Week 12
Primary Incidence of treatment-emergent adverse events (TEAEs) 16 weeks
Primary Incidence of serious adverse events (SAEs) 20 weeks
Primary Incidence of TEAEs leading to discontinuation 16 weeks
See also
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