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

Last updated: March 24, 2025
Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Overall Status: Completed

Phase

2

Condition

Psoriasis And Psoriatic Disorders

Warts

Rosacea

Treatment

DC-806

Placebo

Clinical Study ID

NCT05896527
DCE806201
J5B-MC-FHAG
2022-502249-90-00
  • Ages 18-70
  • All Genders

Study Summary

This was a 12-week treatment, 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 evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.

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

Total Participants: 229
Treatment Group(s): 2
Primary Treatment: DC-806
Phase: 2
Study Start date:
May 02, 2023
Estimated Completion Date:
March 25, 2024

Connect with a study center

  • DICE Therapeutics Study Site

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Kirk Barber Research

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Alberta DermaSurgery Centre - Probity - PPDS

    Edmonton, Alberta T6G 1C2
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Edmonton, Alberta T6G 1C2
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Enverus Medical Research - Probity - PPDS

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc. - Probity - PPDS

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • CCA Medical Research - Probity - PPDS

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Dermatrials Research

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Lynderm Research Inc. - Probity - PPDS

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • DermEdge Research Probity - PPDS

    Mississauga, Ontario
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Alliance Clinical Trials - Probity - PPDS

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • DICE Therapeutics Study Site

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • CCR Prague s.r.o. - PRATIA - PPDS

    Praha, Praha, Hlavní Mesto 130 00
    Czechia

    Site Not Available

  • DICE Therapeutics Study Site

    Praha, Praha, Hlavní Mesto 100 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS

    Praha, Praha, Hlavní Mesto 100 00
    Czechia

    Site Not Available

  • CCR Prague s.r.o. - PRATIA - PPDS

    Praha 10, 100 00
    Czechia

    Site Not Available

  • DICE Therapeutics Study Site

    Praha 10, 100 00
    Czechia

    Site Not Available

  • DICE Therapeutics Study Site

    Praha 5, 150 00
    Czechia

    Site Not Available

  • DICE Therapeutics Study Site

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Leipzig, Sachsen 4103
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Berlin, 10117
    Germany

    Site Not Available

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Lübeck, 23538
    Germany

    Site Not Available

  • DICE Therapeutics Study Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Allergo-Derm Bakos Kft.

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Kaposvár, Somogy 7400
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Szombathely, Vas 9700
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Budapest, 1085
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1085
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • DICE Therapeutics Study Site

    Veszprém, 8200
    Hungary

    Site Not Available

  • MedMare Bt

    Veszprém, 8200
    Hungary

    Site Not Available

  • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

    Wroclaw, Dolnoslaskie 50-566
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Wroclaw, Dolnoslaskie 51-685
    Poland

    Site Not Available

  • Wro Medica

    Wroclaw, Dolnoslaskie 51-685
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Lódz, Lódzkie 90-436
    Poland

    Site Not Available

  • Dermoklinika-Centrum Medyczne s.c

    Lódz, Lódzkie 90-436
    Poland

    Site Not Available

  • Centrum Medyczne Reuma Park NZOZ

    Warszawa, Mazowieckie 02-665
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Warszawa, Mazowieckie 02-665
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Rzeszów, Podkarpackie 35-055
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszów, Podkarpackie 35-055
    Poland

    Site Not Available

  • ClinicMed Daniluk, Nowak Spólka Komandytowa

    Bialystok, Podlaskie 15-879
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Bialystok, Podlaskie 15-879
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, Slaskie 40-611
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Katowice, Slaskie 40-611
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Szczecin, Zachodniopomorskie 70-332
    Poland

    Site Not Available

  • Laser Clinic S.C.

    Szczecin, Zachodniopomorskie 70-332
    Poland

    Site Not Available

  • DICE Therapeutics Study Site

    Barcelona, 8041
    Spain

    Site Not Available

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Site Not Available

  • DICE Therapeutics Study Site

    Las Palmas De Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas De Gran Canaria, 35010
    Spain

    Site Not Available

  • DICE Therapeutics Study Site

    Madrid, 28026
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28026
    Spain

    Site Not Available

  • CHUS - H. Clinico U. de Santiago

    Santiago De Compostela, 50009
    Spain

    Site Not Available

  • DICE Therapeutics Study Site

    Santiago De Compostela, 50009
    Spain

    Site Not Available

  • AES - DRS -NW Consortium Lancashire

    Chorley, Lancashire PR7 7NA
    United Kingdom

    Site Not Available

  • DICE Therapeutics Study Site

    Chorley, Lancashire PR7 7NA
    United Kingdom

    Site Not Available

  • DICE Therapeutics Study Site

    Liverpool, Lancashire L22 0LG
    United Kingdom

    Site Not Available

  • Synexus Merseyside Clinical Research Centre

    Liverpool, Lancashire L22 0LG
    United Kingdom

    Site Not Available

  • DICE Therapeutics Study Site

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • Medicines Evaluation Unit

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • DICE Therapeutics Study Site

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Northwest Arkansas Clinical Trials Center PLLC

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708-3701
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    San Francisco, California 94132-1910
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404-2120
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Santa Monica, California 90404-2120
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Coral Gables, Florida 33134-3901
    United States

    Active - Recruiting

  • Driven Research LLC

    Coral Gables, Florida 33134-3901
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Naples, Florida 34102-6538
    United States

    Active - Recruiting

  • Kirsch Dermatology - Probity - PPDS

    Naples, Florida 34102-6538
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Saint Petersburg, Florida 33713-8012
    United States

    Site Not Available

  • GCP Global Clinical Professionals, LLC

    Saint Petersburg, Florida 33713-8012
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Tampa, Florida 33613-1244
    United States

    Active - Recruiting

  • ForCare Clinical Research - CenExel FCR - PPDS

    Tampa, Florida 33613-1244
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Indianapolis, Indiana 46250-2041
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana 46250-2041
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Plainfield, Indiana 46168-2792
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168-2792
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Louisville, Kentucky 40202-2862
    United States

    Site Not Available

  • Dermatology Specialists Research - 501 S 2nd St

    Louisville, Kentucky 40202-2862
    United States

    Site Not Available

  • ALLCUTIS Research, LLC.

    Portsmouth, New Hampshire 03801-7156
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Portsmouth, New Hampshire 03801-7156
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    New York, New York 10003-3314
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Mason, Ohio 45040-4520
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio - Probity - PPDS

    Mason, Ohio 45040-4520
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Philadelphia, Pennsylvania 19103-4738
    United States

    Site Not Available

  • Paddington Testing Company Inc

    Philadelphia, Pennsylvania 19103-4738
    United States

    Site Not Available

  • Center for Clinical Studies - Webster

    Webster, Texas 77598-4927
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Webster, Texas 77598-4927
    United States

    Site Not Available

  • DICE Therapeutics Study Site

    Norfolk, Virginia 23502-3945
    United States

    Site Not Available

  • Virginia Clinical Research Inc

    Norfolk, Virginia 23502-3945
    United States

    Site Not Available

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