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

Phase 2

Recruiting

• Conditions: Dengue
• Interventions: Drug: EYU688; Drug: Placebo

• Registration Number: NCT06006559
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2024-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-02-17
• Study Completion: 2026-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EYU688	EYU688	EYU688 administered by oral route
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start	From predose to 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Ho Chi Minh, Vietnam