Psoriasis Clinical Trial

A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

229

Study ID:

NCT05896527

Recruitment Status:

Active, not recruiting

Sponsor:

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

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There are 61 Locations for this study

See Locations Near You

Northwest Arkansas Clinical Trials Center PLLC
Rogers Arkansas, 72758, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Driven Research LLC
Coral Gables Florida, 33134, United States
Kirsch Dermatology - Probity - PPDS
Naples Florida, 34102, United States
GCP Global Clinical Professionals, LLC
Saint Petersburg Florida, 33713, United States
ForCare Clinical Research - CenExel FCR - PPDS
Tampa Florida, 33613, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis Indiana, 46250, United States
The Indiana Clinical Trials Center, PC
Plainfield Indiana, 46168, United States
Dermatology Specialists Research - 501 S 2nd St
Louisville Kentucky, 40202, United States
ALLCUTIS Research, LLC.
Portsmouth New Hampshire, 03801, United States
DICE Therapeutics Study Site
New York New York, 10003, United States
Dermatologists of Southwest Ohio - Probity - PPDS
Mason Ohio, 45040, United States
Paddington Testing Company Inc
Philadelphia Pennsylvania, 19103, United States
Center for Clinical Studies - Webster
Webster Texas, 77598, United States
Virginia Clinical Research Inc
Norfolk Virginia, 23502, United States
Kirk Barber Research
Calgary Alberta, T2G 1, Canada
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton Alberta, T6G 1, Canada
Enverus Medical Research - Probity - PPDS
Surrey British Columbia, V3V 0, Canada
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg Manitoba, R3M 3, Canada
CCA Medical Research - Probity - PPDS
Ajax Ontario, L1S 7, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie Ontario, L4M 7, Canada
Dermatrials Research
Hamilton Ontario, L8N 1, Canada
Lynderm Research Inc. - Probity - PPDS
Markham Ontario, L3P 1, Canada
DermEdge Research Probity - PPDS
Mississauga Ontario, , Canada
DICE Therapeutics Study Site
North York Ontario, M2M 4, Canada
Alliance Clinical Trials - Probity - PPDS
Waterloo Ontario, N2J 1, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Quebec , G1V 4, Canada
Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
Praha Praha, Hlavní Mesto, 100 0, Czechia
CCR Prague s.r.o. - PRATIA - PPDS
Praha Praha, Hlavní Mesto, 130 0, Czechia
CCR Prague s.r.o. - PRATIA - PPDS
Praha 10 , 100 0, Czechia
DICE Therapeutics Study Site
Praha 5 , 150 0, Czechia
DICE Therapeutics Study Site
Erlangen Bayern, 91054, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main Hessen, 60590, Germany
DICE Therapeutics Study Site
Bonn Nordrhein-Westfalen, 53127, Germany
DICE Therapeutics Study Site
Münster Nordrhein-Westfalen, 48149, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden Sachsen, 1307, Germany
DICE Therapeutics Study Site
Leipzig Sachsen, 4103, Germany
DICE Therapeutics Study Site
Berlin , 10117, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin , 10789, Germany
DICE Therapeutics Study Site
Lübeck , 23538, Germany
DICE Therapeutics Study Site
Tübingen , 72076, Germany
Allergo-Derm Bakos Kft.
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
DICE Therapeutics Study Site
Kaposvár Somogy, 7400, Hungary
DICE Therapeutics Study Site
Szombathely Vas, 9700, Hungary
Semmelweis Egyetem
Budapest , 1085, Hungary
DICE Therapeutics Study Site
Gyöngyös , 3200, Hungary
MedMare Bt
Veszprém , 8200, Hungary
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw Dolnoslaskie, 50-56, Poland
Wro Medica
Wroclaw Dolnoslaskie, 51-68, Poland
Dermoklinika-Centrum Medyczne s.c
Lódz Lódzkie, 90-43, Poland
Centrum Medyczne Reuma Park NZOZ
Warszawa Mazowieckie, 02-66, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów Podkarpackie, 35-05, Poland
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok Podlaskie, 15-87, Poland
Centrum Medyczne Angelius Provita
Katowice Slaskie, 40-61, Poland
Laser Clinic S.C.
Szczecin Zachodniopomorskie, 70-33, Poland
Hospital de La Santa Creu i Sant Pau
Barcelona , 8041, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas De Gran Canaria , 35010, Spain
Hospital Universitario 12 de Octubre
Madrid , 28026, Spain
CHUS - H. Clinico U. de Santiago
Santiago De Compostela , 50009, Spain
AES - DRS -NW Consortium Lancashire
Chorley Lancashire, PR7 7, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool Lancashire, L22 0, United Kingdom
Medicines Evaluation Unit
Manchester , M23 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

229

Study ID:

NCT05896527

Recruitment Status:

Active, not recruiting

Sponsor:


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

How clear is this clinincal trial information?

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