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.
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
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There are 61 Locations for this study
Rogers Arkansas, 72758, United States
Fountain Valley California, 92708, United States
Santa Monica California, 90404, United States
Coral Gables Florida, 33134, United States
Naples Florida, 34102, United States
Saint Petersburg Florida, 33713, United States
Tampa Florida, 33613, United States
Indianapolis Indiana, 46250, United States
Plainfield Indiana, 46168, United States
Louisville Kentucky, 40202, United States
Portsmouth New Hampshire, 03801, United States
New York New York, 10003, United States
Mason Ohio, 45040, United States
Philadelphia Pennsylvania, 19103, United States
Webster Texas, 77598, United States
Norfolk Virginia, 23502, United States
Calgary Alberta, T2G 1, Canada
Edmonton Alberta, T6G 1, Canada
Surrey British Columbia, V3V 0, Canada
Winnipeg Manitoba, R3M 3, Canada
Ajax Ontario, L1S 7, Canada
Barrie Ontario, L4M 7, Canada
Hamilton Ontario, L8N 1, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, , Canada
North York Ontario, M2M 4, Canada
Waterloo Ontario, N2J 1, Canada
Quebec , G1V 4, Canada
Praha Praha, Hlavní Mesto, 100 0, Czechia
Praha Praha, Hlavní Mesto, 130 0, Czechia
Praha 10 , 100 0, Czechia
Praha 5 , 150 0, Czechia
Erlangen Bayern, 91054, Germany
Frankfurt am Main Hessen, 60590, Germany
Bonn Nordrhein-Westfalen, 53127, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Dresden Sachsen, 1307, Germany
Leipzig Sachsen, 4103, Germany
Berlin , 10117, Germany
Berlin , 10789, Germany
Lübeck , 23538, Germany
Tübingen , 72076, Germany
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
Kaposvár Somogy, 7400, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1085, Hungary
Gyöngyös , 3200, Hungary
Veszprém , 8200, Hungary
Wroclaw Dolnoslaskie, 50-56, Poland
Wroclaw Dolnoslaskie, 51-68, Poland
Lódz Lódzkie, 90-43, Poland
Warszawa Mazowieckie, 02-66, Poland
Rzeszów Podkarpackie, 35-05, Poland
Bialystok Podlaskie, 15-87, Poland
Katowice Slaskie, 40-61, Poland
Szczecin Zachodniopomorskie, 70-33, Poland
Barcelona , 8041, Spain
Las Palmas De Gran Canaria , 35010, Spain
Madrid , 28026, Spain
Santiago De Compostela , 50009, Spain
Chorley Lancashire, PR7 7, United Kingdom
Liverpool Lancashire, L22 0, United Kingdom
Manchester , M23 9, United Kingdom
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