Phase
Condition
Psoriasis And Psoriatic Disorders
Warts
Rosacea
Treatment
DC-806
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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% BSApsoriasis involvement, sPGA score of ≥3, and PASI score ≥12 at the Screeningand 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 WOCBPmust be willing to use a highly effective method of contraception during the studyand for ≥30 days after the last dose of study drug
Willing to discontinue topical and/or systemic therapies for psoriasis before thefirst dose of study drug
Exclusion
Key Exclusion Criteria:
Have had a clinically significant flare of psoriasis during the 12 weeks before theBaseline visit, as assessed by the Investigator
History of erythrodermic psoriasis, generalized or localized pustular psoriasis,predominantly guttate psoriasis, medication-induced or medication-exacerbatedpsoriasis
History of chronic infections including human immunodeficiency virus (HIV) or viralhepatitis (hepatitis B virus [HBV], hepatitis C virus [HCV])
History of active tuberculosis (TB)
History or evidence of active infection (including but not limited to coronavirusdisease 2019 [COVID-19] infection) and/or febrile illness within 7 days, seriousinfections leading to hospitalization and intravenous antibiotic treatment within 90days, or serious infection requiring antibiotic treatment within 30 days before thefirst dose of study drug
History of malignancy or lymphoproliferative disease except resected cutaneoussquamous 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 bya 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 ≥3months of therapy) to one or more therapeutic agents targeted to IL-17 (includingbut not limited to secukinumab, ixekizumab, brodalumab, bimekizumab)
Systemic use of known strong and moderate cytochrome P450 (CYP)3A4 inhibitors orstrong CYP3A4 inducers from Screening through the end of the study
A 12-lead electrocardiogram (ECG) at Screening that demonstrates clinicallysignificant abnormalities or criteria associated with QT interval abnormalitiesincluding prolongation of QT interval corrected for heart rate using Fridericia'sformula (QTcF) (>500 msec)
Laboratory values meeting the following criteria within the screening period beforethe 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 participantswith isolated elevation of indirect bilirubin relating to a confirmed diagnosisof Gilbert syndrome
Estimated glomerular filtration rate (GFR) by simplified 4-variableModification 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 clinicallysignificant laboratory abnormality that would affect interpretation of study data orthe participant's enrollment in the study
Study Design
Connect with a study center
DICE Therapeutics Study Site
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Kirk Barber Research
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta T6G 1C2
CanadaSite Not Available
DICE Therapeutics Study Site
Edmonton, Alberta T6G 1C2
CanadaSite Not Available
DICE Therapeutics Study Site
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Enverus Medical Research - Probity - PPDS
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
DICE Therapeutics Study Site
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
Wiseman Dermatology Research Inc. - Probity - PPDS
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
CCA Medical Research - Probity - PPDS
Ajax, Ontario L1S 7K8
CanadaSite Not Available
DICE Therapeutics Study Site
Ajax, Ontario L1S 7K8
CanadaSite Not Available
DICE Therapeutics Study Site
Barrie, Ontario L4M 7G1
CanadaSite Not Available
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
Barrie, Ontario L4M 7G1
CanadaSite Not Available
DICE Therapeutics Study Site
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
Dermatrials Research
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
DICE Therapeutics Study Site
Markham, Ontario L3P 1X2
CanadaSite Not Available
Lynderm Research Inc. - Probity - PPDS
Markham, Ontario L3P 1X2
CanadaSite Not Available
DermEdge Research Probity - PPDS
Mississauga, Ontario
CanadaSite Not Available
DICE Therapeutics Study Site
North York, Ontario M2M 4J5
CanadaSite Not Available
Alliance Clinical Trials - Probity - PPDS
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
DICE Therapeutics Study Site
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Quebec, G1V 4X7
CanadaSite Not Available
DICE Therapeutics Study Site
Quebec, G1V 4X7
CanadaSite Not Available
CCR Prague s.r.o. - PRATIA - PPDS
Praha, Praha, Hlavní Mesto 130 00
CzechiaSite Not Available
DICE Therapeutics Study Site
Praha, Praha, Hlavní Mesto 100 00
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
Praha, Praha, Hlavní Mesto 100 00
CzechiaSite Not Available
CCR Prague s.r.o. - PRATIA - PPDS
Praha 10, 100 00
CzechiaSite Not Available
DICE Therapeutics Study Site
Praha 10, 100 00
CzechiaSite Not Available
DICE Therapeutics Study Site
Praha 5, 150 00
CzechiaSite Not Available
DICE Therapeutics Study Site
Erlangen, Bayern 91054
GermanySite Not Available
DICE Therapeutics Study Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt am Main, Hessen 60590
GermanySite Not Available
DICE Therapeutics Study Site
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
DICE Therapeutics Study Site
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
DICE Therapeutics Study Site
Dresden, Sachsen 1307
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Sachsen 1307
GermanySite Not Available
DICE Therapeutics Study Site
Leipzig, Sachsen 4103
GermanySite Not Available
DICE Therapeutics Study Site
Berlin, 10117
GermanySite Not Available
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
GermanySite Not Available
DICE Therapeutics Study Site
Lübeck, 23538
GermanySite Not Available
DICE Therapeutics Study Site
Tübingen, 72076
GermanySite Not Available
Allergo-Derm Bakos Kft.
Szolnok, Jász-Nagykun-Szolnok 5000
HungarySite Not Available
DICE Therapeutics Study Site
Szolnok, Jász-Nagykun-Szolnok 5000
HungarySite Not Available
DICE Therapeutics Study Site
Kaposvár, Somogy 7400
HungarySite Not Available
DICE Therapeutics Study Site
Szombathely, Vas 9700
HungarySite Not Available
DICE Therapeutics Study Site
Budapest, 1085
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1085
HungarySite Not Available
DICE Therapeutics Study Site
Gyöngyös, 3200
HungarySite Not Available
DICE Therapeutics Study Site
Veszprém, 8200
HungarySite Not Available
MedMare Bt
Veszprém, 8200
HungarySite Not Available
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Dolnoslaskie 50-566
PolandSite Not Available
DICE Therapeutics Study Site
Wroclaw, Dolnoslaskie 51-685
PolandSite Not Available
Wro Medica
Wroclaw, Dolnoslaskie 51-685
PolandSite Not Available
DICE Therapeutics Study Site
Lódz, Lódzkie 90-436
PolandSite Not Available
Dermoklinika-Centrum Medyczne s.c
Lódz, Lódzkie 90-436
PolandSite Not Available
Centrum Medyczne Reuma Park NZOZ
Warszawa, Mazowieckie 02-665
PolandSite Not Available
DICE Therapeutics Study Site
Warszawa, Mazowieckie 02-665
PolandSite Not Available
DICE Therapeutics Study Site
Rzeszów, Podkarpackie 35-055
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie 35-055
PolandSite Not Available
ClinicMed Daniluk, Nowak Spólka Komandytowa
Bialystok, Podlaskie 15-879
PolandSite Not Available
DICE Therapeutics Study Site
Bialystok, Podlaskie 15-879
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, Slaskie 40-611
PolandSite Not Available
DICE Therapeutics Study Site
Katowice, Slaskie 40-611
PolandSite Not Available
DICE Therapeutics Study Site
Szczecin, Zachodniopomorskie 70-332
PolandSite Not Available
Laser Clinic S.C.
Szczecin, Zachodniopomorskie 70-332
PolandSite Not Available
DICE Therapeutics Study Site
Barcelona, 8041
SpainSite Not Available
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
SpainSite Not Available
DICE Therapeutics Study Site
Las Palmas De Gran Canaria, 35010
SpainSite Not Available
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas De Gran Canaria, 35010
SpainSite Not Available
DICE Therapeutics Study Site
Madrid, 28026
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28026
SpainSite Not Available
CHUS - H. Clinico U. de Santiago
Santiago De Compostela, 50009
SpainSite Not Available
DICE Therapeutics Study Site
Santiago De Compostela, 50009
SpainSite Not Available
AES - DRS -NW Consortium Lancashire
Chorley, Lancashire PR7 7NA
United KingdomSite Not Available
DICE Therapeutics Study Site
Chorley, Lancashire PR7 7NA
United KingdomSite Not Available
DICE Therapeutics Study Site
Liverpool, Lancashire L22 0LG
United KingdomSite Not Available
Synexus Merseyside Clinical Research Centre
Liverpool, Lancashire L22 0LG
United KingdomSite Not Available
DICE Therapeutics Study Site
Manchester, M23 9QZ
United KingdomSite Not Available
Medicines Evaluation Unit
Manchester, M23 9QZ
United KingdomSite Not Available
DICE Therapeutics Study Site
Rogers, Arkansas 72758
United StatesSite Not Available
Northwest Arkansas Clinical Trials Center PLLC
Rogers, Arkansas 72758
United StatesSite Not Available
DICE Therapeutics Study Site
Fountain Valley, California 92708-3701
United StatesSite Not Available
First OC Dermatology
Fountain Valley, California 92708-3701
United StatesSite Not Available
DICE Therapeutics Study Site
San Francisco, California 94132-1910
United StatesSite Not Available
Clinical Science Institute
Santa Monica, California 90404-2120
United StatesSite Not Available
DICE Therapeutics Study Site
Santa Monica, California 90404-2120
United StatesSite Not Available
DICE Therapeutics Study Site
Coral Gables, Florida 33134-3901
United StatesActive - Recruiting
Driven Research LLC
Coral Gables, Florida 33134-3901
United StatesSite Not Available
DICE Therapeutics Study Site
Naples, Florida 34102-6538
United StatesActive - Recruiting
Kirsch Dermatology - Probity - PPDS
Naples, Florida 34102-6538
United StatesSite Not Available
DICE Therapeutics Study Site
Saint Petersburg, Florida 33713-8012
United StatesSite Not Available
GCP Global Clinical Professionals, LLC
Saint Petersburg, Florida 33713-8012
United StatesSite Not Available
DICE Therapeutics Study Site
Tampa, Florida 33613-1244
United StatesActive - Recruiting
ForCare Clinical Research - CenExel FCR - PPDS
Tampa, Florida 33613-1244
United StatesSite Not Available
DICE Therapeutics Study Site
Indianapolis, Indiana 46250-2041
United StatesSite Not Available
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana 46250-2041
United StatesSite Not Available
DICE Therapeutics Study Site
Plainfield, Indiana 46168-2792
United StatesSite Not Available
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168-2792
United StatesSite Not Available
DICE Therapeutics Study Site
Louisville, Kentucky 40202-2862
United StatesSite Not Available
Dermatology Specialists Research - 501 S 2nd St
Louisville, Kentucky 40202-2862
United StatesSite Not Available
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire 03801-7156
United StatesSite Not Available
DICE Therapeutics Study Site
Portsmouth, New Hampshire 03801-7156
United StatesSite Not Available
DICE Therapeutics Study Site
New York, New York 10003-3314
United StatesSite Not Available
DICE Therapeutics Study Site
Mason, Ohio 45040-4520
United StatesSite Not Available
Dermatologists of Southwest Ohio - Probity - PPDS
Mason, Ohio 45040-4520
United StatesSite Not Available
DICE Therapeutics Study Site
Philadelphia, Pennsylvania 19103-4738
United StatesSite Not Available
Paddington Testing Company Inc
Philadelphia, Pennsylvania 19103-4738
United StatesSite Not Available
Center for Clinical Studies - Webster
Webster, Texas 77598-4927
United StatesSite Not Available
DICE Therapeutics Study Site
Webster, Texas 77598-4927
United StatesSite Not Available
DICE Therapeutics Study Site
Norfolk, Virginia 23502-3945
United StatesSite Not Available
Virginia Clinical Research Inc
Norfolk, Virginia 23502-3945
United StatesSite Not Available
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