A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.

Study Overview

• Status: Recruiting
• Conditions: Dengue
• Intervention / Treatment: Drug: EYU688; Drug: Placebo

Detailed Description

This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever.

Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK [cohort 1] and sparse PK sampling [cohort 2]).

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Brazil
  • Sao Jose Rio Preto, Brazil, 15090 000
    • Recruiting
    • Novartis Investigative Site
  • Amazonas
    • Manaus, Amazonas, Brazil, 69040-000
      • Recruiting
      • Novartis Investigative Site
  • Federal District
    • Brasília, Federal District, Brazil, 71635-580
      • Recruiting
      • Novartis Investigative Site
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
      • Recruiting
      • Novartis Investigative Site
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Recruiting
      • Novartis Investigative Site
• Colombia
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080012
      • Recruiting
      • Novartis Investigative Site
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 681017
      • Recruiting
      • Novartis Investigative Site
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Recruiting
      • Novartis Investigative Site
• India
  • Karnataka
    • Belagavi, Karnataka, India, 590010
      • Recruiting
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • Withdrawn
      • Novartis Investigative Site
    • Pune, Maharashtra, India, 411013
      • Recruiting
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Recruiting
      • Novartis Investigative Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600113
      • Recruiting
      • Novartis Investigative Site
• Malaysia
  • Kuala Selangor, Malaysia, 68000
    • Recruiting
    • Novartis Investigative Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25200
      • Recruiting
      • Novartis Investigative Site
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Recruiting
      • Novartis Investigative Site
  • Pulau Pinang
    • Seberang Jaya, Pulau Pinang, Malaysia, 13700
      • Recruiting
      • Novartis Investigative Site
  • Sarawak
    • Miri, Sarawak, Malaysia, 98000
      • Recruiting
      • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Novartis Investigative Site
  • Singapore, Singapore, S308433
    • Recruiting
    • Novartis Investigative Site
• Vietnam
  • Haiphong, Vietnam, 180000
    • Recruiting
    • Novartis Investigative Site
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Novartis Investigative Site
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, 18 - 60 years old (inclusive).
• History or presence of fever (≥ 38°C). At least one of the following criteria indicating dengue infection:
• Nausea or vomiting.
• Presence of rash, aches or pains including headache, muscle or joint pain.
• Onset of fever ≤ 48 hours prior to treatment start.
• Positive test on dengue fever.

Exclusion Criteria:

• Participants with any of abnormalities of clinical laboratory parameters.
• Usage of any anticoagulant drugs.
• Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.
• Pregnant or nursing (lactating) women.
• Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.

• Participants with any of the following abnormalities of clinical laboratory parameters at screening:

  • Hemoglobin <12.0 g/dL in males; <11.0 g/dL in females
  • Hematocrit >52 % in males; >46 % in females
  • Absolute neutrophil count <1500/μL
  • Platelet count <80,000/mm3
  • Creatinine >165 μmol/L in males; >130 μmol/L in females
  • Serum creatine kinase > 600 U/L
  • ALT, AST levels more than 1.5X upper limit of normal (ULN)
  • Total bilirubin >24 μmol/L
• Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screening.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug.

• History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening:

  • QTcF > 450 msec (males)
  • QTcF > 460 msec (females)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Matching placebo administered orally as capsules
Experimental: EYU688; EYU688 administered by oral route	Drug: EYU688; EYU688 administered by oral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start	Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.	From predose to 48 hours post treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃	Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.	From fever onset to Day 15
Time from fever onset to the first of two consecutive negative viremia by PCR	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15	From fever onset to Day 15
Area under the log-transformed viremia curve (AUC) from the first dose to Day 15	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15	From fever onset to Day 15
Changes of viral load over time	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15	From baseline to Day 15
Incidence and severity of Adverse Events (AEs)	Incidence and severity of AEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.	From inclusion to Day 15
Incidence and severity of Serious Adverse Events (SAEs)	Incidence and severity of SAEs by treatment group	From inclusion to Day 35
Change of white blood cell count over time from baseline	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Change of platelet count over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Change of AST, ALT levels over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
No warning signs by day 7 of fever onset	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Diagnosis of severe dengue fever	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Plasma leakage	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Requiring fluid infusion	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Time from fever onset to clinical recovery	Assessment of the dengue fever clinical evolution under EYU688	From fever onset to Day 15
PK parameter (Cmax)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
PK parameter (Tmax)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
PK parameter (partial AUCs)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
PK concentrations following multiple doses	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dengue; EYU688
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CEYU688A12201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No