Ended Therapeutic exploratory (Phase II) Plaque Psoriasis

A study to understand how well DC806 works and how safe it is in participants with plaque psoriasis

EU CTIS ID: 2022-502249-90-00

What this study is testing

To compare the efficacy of multiple doses of DC-806 versus placebo in adult participants with moderate to severe plaque psoriasis To compare the safety and tolerability of multiple doses of DC-806 versus placebo in adult participants with moderate to severe plaque psoriasis

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • 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

You likely can't join if

  • • 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 "

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • United States
  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.