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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

DICE Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

31 Aug 2023 → 26 Mar 2024

Decision date (initial)

2023-08-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DICE Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others, Pharmacokinetic

• 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

Secondary objectives 1

1. • To compare the efficacy of various DC-806 dose regimens in adult participants with moderate to severe plaque psoriasis • To compare the efficacy of multiple doses of DC-806 versus placebo on additional efficacy endpoints in adult participants with moderate to severe plaque psoriasis • To assess the PK of DC-806 and intersubject variability in adult participants with moderate to severe plaque psoriasis

Conditions and MedDRA coding

Plaque Psoriasis

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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 1

1. • 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 "

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75) at Week 12 • Incidence proportion of TEAEs, SAEs, and TEAEs leading to discontinuation

Secondary endpoints 3

1. • Proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12 • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12
2. • 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 • Proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints
3. • Change and percent change from Baseline in PASI score at all scheduled timepoints • Change and percent change from Baseline in the percentage of BSA affected at all scheduled timepoints • Measurement of plasma concentration of DC-806 at scheduled timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

DICE Therapeutics Inc.

Sponsor organisation

DICE Therapeutics Inc.

Address

400 East Jamie Court Suite 300

City

South San Francisco

Postcode

94080-6230

Country

United States

Scientific contact point

Organisation

DICE Therapeutics Inc.

Contact name

Jeff Enejosa MD

Public contact point

Organisation

DICE Therapeutics Inc.

Contact name

Vandana Nathan

Third parties 10

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications