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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Other: Placebo; Drug: DC-806

• Registration Number: NCT05896527
• Lead Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2025-03
• Results First Submitted: 2025-03-24
• Results First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Results First Posted: 2025-04-04
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo tablets orally twice daily (BID) for 12 weeks.
DC-806 200 mg BID	DC-806	Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
DC-806 400 mg BID	DC-806	Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
DC-806 600 mg QD	DC-806	Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
DC-806 800 mg BID	DC-806	Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations	Baseline through End of follow-up (Up to 16 weeks)	* 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.

Trial Locations

Locations (43)

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Lynderm Research Inc. - Probity - PPDS; 🇨🇦 Markham, Ontario, Canada

MedMare Bt; 🇭🇺 Veszprém, Hungary

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Driven Research LLC; 🇺🇸 Coral Gables, Florida, United States

Kirsch Dermatology - Probity - PPDS; 🇺🇸 Naples, Florida, United States

GCP Global Clinical Professionals, LLC; 🇺🇸 Saint Petersburg, Florida, United States

The Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Dermatology Specialists Research - 501 S 2nd St; 🇺🇸 Louisville, Kentucky, United States

Dermatologists of Southwest Ohio - Probity - PPDS; 🇺🇸 Mason, Ohio, United States

Paddington Testing Company Inc; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Clinical Research Inc; 🇺🇸 Norfolk, Virginia, United States

Center for Clinical Studies - Webster; 🇺🇸 Webster, Texas, United States

CCA Medical Research - Probity - PPDS; 🇨🇦 Ajax, Ontario, Canada

SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS; 🇨🇦 Barrie, Ontario, Canada

Dermatrials Research; 🇨🇦 Hamilton, Ontario, Canada

DermEdge Research Probity - PPDS; 🇨🇦 Mississauga, Ontario, Canada

Alliance Clinical Trials - Probity - PPDS; 🇨🇦 Waterloo, Ontario, Canada

CCR Prague s.r.o. - PRATIA - PPDS; 🇨🇿 Praha 10, Czechia

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ); 🇨🇦 Quebec, Canada

Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS; 🇨🇿 Praha, Praha, Hlavní Mesto, Czechia

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany

ISA - Interdisciplinary Study Association GmbH; 🇩🇪 Berlin, Germany

Allergo-Derm Bakos Kft.; 🇭🇺 Szolnok, Jász-Nagykun-Szolnok, Hungary

Semmelweis Egyetem; 🇭🇺 Budapest, Hungary

Wro Medica; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Dermoklinika-Centrum Medyczne s.c; 🇵🇱 Lódz, Lódzkie, Poland

Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Laser Clinic S.C.; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie; 🇵🇱 Rzeszów, Podkarpackie, Poland

ClinicMed Daniluk, Nowak Spólka Komandytowa; 🇵🇱 Bialystok, Podlaskie, Poland

Centrum Medyczne Angelius Provita; 🇵🇱 Katowice, Slaskie, Poland

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario de Gran Canaria Doctor Negrin; 🇪🇸 Las Palmas De Gran Canaria, Spain

Centrum Medyczne Reuma Park NZOZ; 🇵🇱 Warszawa, Mazowieckie, Poland

CHUS - H. Clinico U. de Santiago; 🇪🇸 Santiago De Compostela, Spain

Synexus Merseyside Clinical Research Centre; 🇬🇧 Liverpool, Lancashire, United Kingdom

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

Enverus Medical Research - Probity - PPDS; 🇨🇦 Surrey, British Columbia, Canada

Alberta DermaSurgery Centre - Probity - PPDS; 🇨🇦 Edmonton, Alberta, Canada

DICE Therapeutics Study Site; 🇭🇺 Gyöngyös, Hungary

ForCare Clinical Research - CenExel FCR - PPDS; 🇺🇸 Tampa, Florida, United States

Wiseman Dermatology Research Inc. - Probity - PPDS; 🇨🇦 Winnipeg, Manitoba, Canada