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

Official title

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

Overview

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 \[cohort 2\]).

Interventions

• Drug EYU688
  EYU688 administered by oral route
• Drug Placebo
  Matching placebo administered orally as capsules

Primary outcome measures

• Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start [Time frame: From predose to 48 hours post treatment start]

Secondary outcome measures (12)

• Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃ [Time frame: From fever onset to Day 15]
• Time from fever onset to the first of two consecutive negative viremia by PCR [Time frame: From fever onset to Day 15]
• Area under the log-transformed viremia curve (AUC) from the first dose to Day 15 [Time frame: From fever onset to Day 15]
• Changes of viral load over time [Time frame: From baseline to Day 15]
• Incidence and severity of Adverse Events (AEs) [Time frame: From inclusion to Day 15]
• Incidence and severity of Serious Adverse Events (SAEs) [Time frame: From inclusion to Day 35]
• Change of white blood cell count over time from baseline [Time frame: From baseline to Day 15]
• Change of platelet count over time [Time frame: From baseline to Day 15]
• Change of hematocrit level and percentage increase from baseline over time [Time frame: From baseline to Day 15]
• Change of AST, ALT levels over time [Time frame: From baseline to Day 15]
• No warning signs by day 7 of fever onset [Time frame: From inclusion to Day 15]
• Diagnosis of severe dengue fever [Time frame: From inclusion to Day 15]

Eligibility criteria

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 3 X 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Brazil · 6 centers

• Novartis Investigative Site — Manaus
• Novartis Investigative Site — Brasília
• Novartis Investigative Site — Rio de Janeiro
• Novartis Investigative Site — Rio Grande
• Novartis Investigative Site — Sorocaba
• Novartis Investigative Site — Sao Jose Rio Preto

India · 5 centers

• Novartis Investigative Site — Belagavi
• Novartis Investigative Site — Mumbai
• Novartis Investigative Site — Pune
• Novartis Investigative Site — Jaipur
• Novartis Investigative Site — Chennai

Malaysia · 5 centers

• Novartis Investigative Site — Kuantan
• Novartis Investigative Site — Ipoh
• Novartis Investigative Site — Seberang Jaya
• Novartis Investigative Site — Miri
• Novartis Investigative Site — Kuala Selangor

Colombia · 3 centers

• Novartis Investigative Site — Barranquilla
• Novartis Investigative Site — Bucaramanga
• Novartis Investigative Site — Cali

Vietnam · 3 centers

• Novartis Investigative Site — Haiphong
• Novartis Investigative Site — Hanoi
• Novartis Investigative Site — Ho Chi Minh City

Singapore · 2 centers

• Novartis Investigative Site — Singapore
• Novartis Investigative Site — Singapore

Publications

• Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21. PMID 42253092

Identifiers

NCT: NCT06006559 · CEYU688A12201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗