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

December 15, 2023 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

A 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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Quebec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research
      • Edmonton, Alberta, Canada, T6G 1C2
        • Alberta DermaSurgery Centre - Probity - PPDS
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research - Probity - PPDS
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc. - Probity - PPDS
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • CCA Medical Research - Probity - PPDS
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. - Probity - PPDS
      • Mississauga, Ontario, Canada
        • DermEdge Research Probity - PPDS
      • North York, Ontario, Canada, M2M 4J5
        • DICE Therapeutics Study Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials - Probity - PPDS
  • Czechia
      • Praha 10, Czechia, 100 00
        • CCR Prague s.r.o. - PRATIA - PPDS
      • Praha 5, Czechia, 150 00
        • DICE Therapeutics Study Site
    • Praha, Hlavní Mesto
      • Praha, Praha, Hlavní Mesto, Czechia, 100 00
        • Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
      • Praha, Praha, Hlavní Mesto, Czechia, 130 00
        • CCR Prague s.r.o. - PRATIA - PPDS
  • Germany
      • Berlin, Germany, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Germany, 10117
        • DICE Therapeutics Study Site
      • Lübeck, Germany, 23538
        • DICE Therapeutics Study Site
      • Tübingen, Germany, 72076
        • DICE Therapeutics Study Site
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • DICE Therapeutics Study Site
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitatsklinikum Frankfurt
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • DICE Therapeutics Study Site
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • DICE Therapeutics Study Site
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
      • Leipzig, Sachsen, Germany, 4103
        • DICE Therapeutics Study Site
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Gyöngyös, Hungary, 3200
        • DICE Therapeutics Study Site
      • Veszprém, Hungary, 8200
        • Medmare Bt
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft.
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • DICE Therapeutics Study Site
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • DICE Therapeutics Study Site
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-566
        • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
      • Wroclaw, Dolnoslaskie, Poland, 51-685
        • Wro Medica
    • Lódzkie
      • Lódz, Lódzkie, Poland, 90-436
        • Dermoklinika-Centrum Medyczne s.c
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-665
        • Centrum Medyczne Reuma Park NZOZ
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-879
        • ClinicMed Daniluk, Nowak Spólka Komandytowa
    • Slaskie
      • Katowice, Slaskie, Poland, 40-611
        • Centrum Medyczne Angelius Provita
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-332
        • Laser Clinic S.C.
  • Spain
      • Barcelona, Spain, 8041
        • Hospital de La Santa Creu I Sant Pau
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Madrid, Spain, 28026
        • Hospital Universitario 12 de Octubre
      • Santiago De Compostela, Spain, 50009
        • CHUS - H. Clinico U. de Santiago
  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • Medicines Evaluation Unit
    • Lancashire
      • Chorley, Lancashire, United Kingdom, PR7 7NA
        • AES - DRS -NW Consortium Lancashire
      • Liverpool, Lancashire, United Kingdom, L22 0LG
        • Synexus Merseyside Clinical Research Centre
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center PLLC
    • California
      • Fountain Valley, California, United States, 92708-3701
        • First OC Dermatology
      • Santa Monica, California, United States, 90404-2120
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, United States, 33134-3901
        • Driven Research LLC
      • Naples, Florida, United States, 34102-6538
        • Kirsch Dermatology - Probity - PPDS
      • Saint Petersburg, Florida, United States, 33713-8012
        • GCP Global Clinical Professionals, LLC
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research - CenExel FCR - PPDS
    • Indiana
      • Indianapolis, Indiana, United States, 46250-2041
        • Dawes Fretzin Clinical Research Group Llc
      • Plainfield, Indiana, United States, 46168-2792
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Louisville, Kentucky, United States, 40202-2862
        • Dermatology Specialists Research - 501 S 2nd St
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801-7156
        • ALLCUTIS Research, LLC.
    • New York
      • New York, New York, United States, 10003-3314
        • DICE Therapeutics Study Site
    • Ohio
      • Mason, Ohio, United States, 45040-4520
        • Dermatologists of Southwest Ohio - Probity - PPDS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103-4738
        • Paddington Testing Company Inc
    • Texas
      • Webster, Texas, United States, 77598-4927
        • Center for Clinical Studies - Webster
    • Virginia
      • Norfolk, Virginia, United States, 23502-3945
        • Virginia Clinical Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1: DC-806 Dose A
Drug: DC-806
DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 2: DC-806 Dose B
Drug: DC-806
DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 3: DC-806 Dose C
Drug: DC-806
DC-806 will be supplied as tablets to be administered orally.
Experimental: Treatment Group 4: DC-806 Dose D
Drug: DC-806
DC-806 will be supplied as tablets to be administered orally.
Placebo Comparator: Treatment Group 5: Placebo
Other: Placebo
Matching placebo will be supplied as tablets to be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75)
Time Frame: Week 12
Week 12
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 16 weeks
16 weeks
Incidence of serious adverse events (SAEs)
Time Frame: 20 weeks
20 weeks
Incidence of TEAEs leading to discontinuation
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

February 21, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCE806201
  • 2022-502249-90-00 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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