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

Plaque Psoriasis Clinical Trial

— Illuminate  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05896527
• Other study ID #: DCE806201
• Secondary ID: 2022-502249-90-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 11, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 12-week, 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 will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 229
• Est. completion date: March 31, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 within the last 5 years 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DC-806
DC-806 will be supplied as tablets to be administered orally.

Other:
• Placebo
Matching placebo will be supplied as tablets to be administered orally.

Locations

Country	Name	City	State
Canada	CCA Medical Research - Probity - PPDS	Ajax	Ontario
Canada	SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS	Barrie	Ontario
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Alberta DermaSurgery Centre - Probity - PPDS	Edmonton	Alberta
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Lynderm Research Inc. - Probity - PPDS	Markham	Ontario
Canada	DermEdge Research Probity - PPDS	Mississauga	Ontario
Canada	DICE Therapeutics Study Site	North York	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec
Canada	Enverus Medical Research - Probity - PPDS	Surrey	British Columbia
Canada	Alliance Clinical Trials - Probity - PPDS	Waterloo	Ontario
Canada	Wiseman Dermatology Research Inc. - Probity - PPDS	Winnipeg	Manitoba
Czechia	CCR Prague s.r.o. - PRATIA - PPDS	Praha	Praha, Hlavní Mesto
Czechia	Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS	Praha	Praha, Hlavní Mesto
Czechia	CCR Prague s.r.o. - PRATIA - PPDS	Praha 10
Czechia	DICE Therapeutics Study Site	Praha 5
Germany	DICE Therapeutics Study Site	Berlin
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	DICE Therapeutics Study Site	Bonn	Nordrhein-Westfalen
Germany	Universitätsklinikum Carl Gustav Carus an der TU Dresden	Dresden	Sachsen
Germany	DICE Therapeutics Study Site	Erlangen	Bayern
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main	Hessen
Germany	DICE Therapeutics Study Site	Leipzig	Sachsen
Germany	DICE Therapeutics Study Site	Lübeck
Germany	DICE Therapeutics Study Site	Münster	Nordrhein-Westfalen
Germany	DICE Therapeutics Study Site	Tübingen
Hungary	Semmelweis Egyetem	Budapest
Hungary	DICE Therapeutics Study Site	Gyöngyös
Hungary	DICE Therapeutics Study Site	Kaposvár	Somogy
Hungary	Allergo-Derm Bakos Kft.	Szolnok	Jász-Nagykun-Szolnok
Hungary	DICE Therapeutics Study Site	Szombathely	Vas
Hungary	MedMare Bt	Veszprém
Poland	ClinicMed Daniluk, Nowak Spólka Komandytowa	Bialystok	Podlaskie
Poland	Centrum Medyczne Angelius Provita	Katowice	Slaskie
Poland	Dermoklinika-Centrum Medyczne s.c	Lódz	Lódzkie
Poland	Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie	Rzeszów	Podkarpackie
Poland	Laser Clinic S.C.	Szczecin	Zachodniopomorskie
Poland	Centrum Medyczne Reuma Park NZOZ	Warszawa	Mazowieckie
Poland	Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p	Wroclaw	Dolnoslaskie
Poland	Wro Medica	Wroclaw	Dolnoslaskie
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrin	Las Palmas De Gran Canaria
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	CHUS - H. Clinico U. de Santiago	Santiago De Compostela
United Kingdom	AES - DRS -NW Consortium Lancashire	Chorley	Lancashire
United Kingdom	Synexus Merseyside Clinical Research Centre	Liverpool	Lancashire
United Kingdom	Medicines Evaluation Unit	Manchester
United States	Driven Research LLC	Coral Gables	Florida
United States	First OC Dermatology	Fountain Valley	California
United States	Dawes Fretzin Clinical Research Group LLC	Indianapolis	Indiana
United States	Dermatology Specialists Research - 501 S 2nd St	Louisville	Kentucky
United States	Dermatologists of Southwest Ohio - Probity - PPDS	Mason	Ohio
United States	Kirsch Dermatology - Probity - PPDS	Naples	Florida
United States	DICE Therapeutics Study Site	New York	New York
United States	Virginia Clinical Research Inc	Norfolk	Virginia
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	ALLCUTIS Research, LLC.	Portsmouth	New Hampshire
United States	Northwest Arkansas Clinical Trials Center PLLC	Rogers	Arkansas
United States	GCP Global Clinical Professionals, LLC	Saint Petersburg	Florida
United States	Clinical Science Institute	Santa Monica	California
United States	ForCare Clinical Research - CenExel FCR - PPDS	Tampa	Florida
United States	Center for Clinical Studies - Webster	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving =75% reduction in Psoriasis Area of Severity Index score (PASI-75)		Week 12
Primary	Incidence of treatment-emergent adverse events (TEAEs)		16 weeks
Primary	Incidence of serious adverse events (SAEs)		20 weeks
Primary	Incidence of TEAEs leading to discontinuation		16 weeks