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

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 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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: DC-806

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
  • Alberta
    • 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
      • Universitätsklinikum Frankfurt
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • DICE Therapeutics Study Site
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • DICE Therapeutics Study Site
  • Sachsen
    • 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 Spolka Komandytowa
  • Slaskie
    • Katowice, Slaskie, Poland, 40-611
      • Centrum Medyczne Angelius Provita
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-332
      • Laser Clinic S.C.
• Spain
  • 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
    • Liverpool, Lancashire, United Kingdom, L22 0LG
      • Synexus Merseyside Clinical Research Centre
• United States
  • 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
    • 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 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

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 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo tablets orally twice daily (BID) for 12 weeks.	Other: Placebo; Matching placebo was supplied as tablets to be administered orally.
Experimental: DC-806 200 mg BID; Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.	Drug: DC-806; DC-806 was supplied as tablets to be administered orally.
Experimental: DC-806 400 mg BID; Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.	Drug: DC-806; DC-806 was supplied as tablets to be administered orally.
Experimental: DC-806 600 mg QD; Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.	Drug: DC-806; DC-806 was supplied as tablets to be administered orally.
Experimental: DC-806 800 mg BID; Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.	Drug: DC-806; DC-806 was supplied as tablets to be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12	Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.	Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations	A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.; An SAE is any untoward medical occurrence that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.	Baseline through End of follow-up (Up to 16 weeks)

Collaborators and Investigators

• Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 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 (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: DCE806201; 2022-502249-90-00 (Other Identifier: EU CTR Number); J5B-MC-FHAG (Other Identifier: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)

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