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
- Trial ID
- 2022-502249-90-00
- Protocol
- DCE806201
- Sponsor
- Dice Therapeutics Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to compare the **efficacy** and **safety** of multiple doses of DC-806 versus placebo in adult participants with moderate to severe plaque psoriasis. This is clinically relevant as it aims to establish the therapeutic potential and safety profile of DC-806, which could offer a new treatment option for individuals suffering from this chronic skin condition.
Secondary objectives include:
- Comparing the efficacy of various DC-806 dose regimens in adult participants with moderate to severe plaque psoriasis.
- Comparing the efficacy of multiple doses of DC-806 versus placebo on additional efficacy endpoints in adult participants with moderate to severe plaque psoriasis.
- Assessing the pharmacokinetics (PK) of DC-806 and intersubject variability in adult participants with moderate to severe plaque psoriasis.
Participants
The clinical trial involves **109 participants** diagnosed with **plaque psoriasis**, focusing on adults aged **18 to 70 years**. Both **male and female** subjects are included, with a **body mass index (BMI)** ranging from **18 to 40 kg/m²**. Participants were selected based on their clinical diagnosis of moderate to severe chronic plaque psoriasis, characterized by at least **10% body surface area (BSA)** involvement, a **static Physician's Global Assessment (sPGA)** score of 3 or higher, and a **Psoriasis Area and Severity Index (PASI)** score of 12 or more. The study population is required to be candidates for phototherapy or systemic therapy. Participants must be willing to discontinue any topical or systemic therapies for psoriasis prior to the study. Women of childbearing potential are required to use a highly effective method of contraception during the study and for at least 30 days after the last dose of the study drug. The trial includes a vulnerable population, ensuring comprehensive safety and efficacy assessments of the investigational drug, DC-806, compared to a placebo.
Plans and Procedures
The clinical trial is designed as a **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**. The trial will involve adult participants aged 18 to 70 years, with a body mass index (BMI) of 18 to 40 kg/m², who have a clinical diagnosis of plaque psoriasis for at least six months prior to the baseline visit. The study will compare multiple doses of DC-806, a small molecule administered as a film-coated tablet for oral use, against a placebo. The maximum daily dose of DC-806 is 1600 mg, with a total dose not exceeding 134.4 g over the treatment period.
The trial is expected to last approximately 12 months, with participant recruitment starting in September 2023 and estimated to conclude by September 2024. Participants will be involved in the study for a maximum of 12 weeks, during which they will attend several study visits. The sequence of visits includes an initial screening visit to confirm eligibility based on inclusion criteria, followed by a baseline visit where treatment will commence. Subsequent follow-up visits will occur at regular intervals to monitor efficacy and safety, with the primary endpoint being the proportion of participants achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) at Week 12. The study will also assess secondary endpoints, including the proportion of participants achieving various levels of PASI reduction and changes in the percentage of body surface area affected.
The end-of-study visit will occur at the conclusion of the treatment period, where final assessments will be conducted. Participants may be withdrawn from the study early if they experience treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) that lead to discontinuation, or if they fail to adhere to the study protocol. The trial aims to provide comprehensive data on the efficacy and safety of DC-806, contributing to the understanding of its potential as a treatment for moderate to severe plaque psoriasis.
Treatment
The clinical trial involves the administration of **DC-806**, an investigational medication, in the form of a **film-coated tablet**. The active substance, DC-806, is a chemical compound developed by DICE THERAPEUTICS, INC. The medication is administered orally, with a maximum daily dose of 1600 mg and a total maximum dose of 134.4 g over a treatment period of up to 12 weeks. The trial aims to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. The dosing schedule is designed to ensure participant compliance, with regular monitoring throughout the study period.
In addition to the experimental treatment, the study includes the use of **DC-806 Placebo tablets** as a comparator. The placebo is also administered in the form of a tablet, matching the appearance and administration route of the active treatment to maintain the double-blind nature of the trial. The placebo group serves as a control to assess the true efficacy and safety of DC-806 by comparing outcomes between the active and placebo groups. Compliance with the dosing regimen is monitored to ensure the integrity of the study results.
Efficacy
The efficacy of DC-806 in the treatment of moderate to severe plaque psoriasis will be assessed through a series of primary and secondary endpoints. The primary endpoint is the proportion of participants achieving a 75% reduction in the **Psoriasis Area and Severity Index** (PASI-75) at Week 12. Secondary endpoints include the proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12, and the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from Baseline at Week 12.
Additional secondary endpoints involve the proportion of participants achieving 50%, 75%, 90%, and 100% reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at all scheduled timepoints, as well as the proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints. Changes and percent changes from Baseline in PASI score and the percentage of body surface area (BSA) affected will also be measured at all scheduled timepoints. Plasma concentration of DC-806 will be measured at scheduled timepoints to further assess efficacy.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female, 18 to 70 years of age, inclusive • Body mass index (BMI) of 18 to 40 kg/m2 • All of the following psoriasis criteria: o Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit o 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 o Candidate for phototherapy or systemic therapy, as assessed by the Investigator • Women of childbearing potential (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
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 14 days, serious infections leading to hospitalization and intravenous antibiotic treatment within 90 days, or serious infection requiring antibiotic treatment within 30 days before thefirst 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: o History of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) within 5 years before the Screening visit o 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 rateusing Fridericia’s formula (QTcF) (>500 msec) • Laboratory values meeting the following criteria within the screening period before the first dose of study drug: o Serum aspartate transaminase ≥2× upper limit of normal (ULN) o Serum alanine transaminase ≥2×ULN o 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 o Serum albumin 3.5 g/dL o Prothrombin time ≥ 4 seconds or International Normalized Ratio 1.7 o Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula <45 mL/min/1.73m2 o Total white blood cell count <3000/μL o Absolute neutrophil count <1500/μL o Platelet count <100,000/μL o 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 "
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Czechia | Not Recruiting | 01 Sept 2023 | 32 |
 Germany | Not Recruiting | 01 Sept 2023 | 36 |
 Hungary | Not Recruiting | 01 Sept 2023 | 20 |
 Poland | Not Recruiting | 01 Sept 2023 | 100 |
 Spain | Not Recruiting | 01 Sept 2023 | 18 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
DC-806 Placebo tablets | Placebo | N/A | — | — | — | N/A |
DC-806 | Test | FILM-COATED TABLET | ORAL USE | 1600 | 12 | PRD10313469 |
DC-806 | Test | FILM-COATED TABLET | ORAL USE | 1600 | 12 | PRD10313470 |
DC-806 | Test | FILM-COATED TABLET | ORAL USE | 1600 | 12 | PRD10313467 |
DC-806 | Test | FILM-COATED TABLET | ORAL USE | 1600 | 12 | PRD10313468 |