Clinical trial NCT05896527: A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
timeFrame: Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations
timeFrame: Baseline through End of follow-up (Up to 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Naples
country: United States
facility: Kirsch Dermatology - Probity - PPDS
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research - CenExel FCR - PPDS
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research - 501 S 2nd St
state: Kentucky
city: New York
country: United States
facility: DICE Therapeutics Study Site
state: New York
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio - Probity - PPDS
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Webster
country: United States
facility: Center for Clinical Studies - Webster
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc
state: Virginia
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre - Probity - PPDS
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research - Probity - PPDS
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc. - Probity - PPDS
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research - Probity - PPDS
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. - Probity - PPDS
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Probity - PPDS
state: Ontario
city: North York
country: Canada
facility: DICE Therapeutics Study Site
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials - Probity - PPDS
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS
state: Praha, Hlavní Mesto
city: Praha
country: Czechia
facility: CCR Prague s.r.o. - PRATIA - PPDS
state: Praha, Hlavní Mesto
city: Praha 10
country: Czechia
facility: CCR Prague s.r.o. - PRATIA - PPDS
city: Praha 5
country: Czechia
facility: DICE Therapeutics Study Site
city: Erlangen
country: Germany
facility: DICE Therapeutics Study Site
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Bonn
country: Germany
facility: DICE Therapeutics Study Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: DICE Therapeutics Study Site
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: DICE Therapeutics Study Site
state: Sachsen
city: Berlin
country: Germany
facility: DICE Therapeutics Study Site
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Lübeck
country: Germany
facility: DICE Therapeutics Study Site
city: Tübingen
country: Germany
facility: DICE Therapeutics Study Site
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft.
state: Jász-Nagykun-Szolnok
city: Kaposvár
country: Hungary
facility: DICE Therapeutics Study Site
state: Somogy
city: Szombathely
country: Hungary
facility: DICE Therapeutics Study Site
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Gyöngyös
country: Hungary
facility: DICE Therapeutics Study Site
city: Veszprém
country: Hungary
facility: MedMare Bt
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Wro Medica
state: Dolnoslaskie
city: Lódz
country: Poland
facility: Dermoklinika-Centrum Medyczne s.c
state: Lódzkie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park NZOZ
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
state: Podkarpackie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spólka Komandytowa
state: Podlaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Slaskie
city: Szczecin
country: Poland
facility: Laser Clinic S.C.
state: Zachodniopomorskie
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago De Compostela
country: Spain
facility: CHUS - H. Clinico U. de Santiago
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
state: Lancashire
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: