A Phase 2 interventional study of EYU688 and Placebo in Dengue, sponsored by Novartis Pharmaceuticals. Recruiting at 27 sites in 7 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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]).
Exclusion Criteria:
Participants with any of the following abnormalities of clinical laboratory parameters at screening:
History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening:
Other protocol-defined inclusion/exclusion criteria may apply.
EYU688 administered by oral route
Drug: EYU688
Matching placebo
Drug: Placebo
EYU688 administered by oral route
Matching placebo administered orally as capsules
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.
Time frame: From predose to 48 hours post treatment start
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From inclusion to Day 15
Incidence and severity of Serious Adverse Events (SAEs)
Incidence and severity of SAEs by treatment group
Time frame: From inclusion to Day 35
Change of white blood cell count over time from baseline
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of platelet count over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of AST, ALT levels over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
No warning signs by day 7 of fever onset
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of severe dengue fever
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Plasma leakage
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Requiring fluid infusion
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Time from fever onset to clinical recovery
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From fever onset to Day 15
PK parameter (Cmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (Tmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (partial AUCs)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK concentrations following multiple doses
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
Plan to share: Yes — 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.
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Novartis Pharmaceuticals