NCT06006559

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
8mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
6 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2024Jan 2027

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2027

Expected
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

August 17, 2023

Last Update Submit

March 23, 2026

Conditions

Dengue

Keywords

DengueEYU688

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • 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

  • Time from fever onset to the first of two consecutive negative viremia by PCR

    From fever onset to Day 15

  • Area under the log-transformed viremia curve (AUC) from the first dose to Day 15

    From fever onset to Day 15

  • Changes of viral load over time

    From baseline to Day 15

  • Incidence and severity of Adverse Events (AEs)

    From inclusion to Day 15

  • +15 more secondary outcomes

Study Arms (2)

EYU688

EXPERIMENTAL

EYU688 administered by oral route

Drug: EYU688

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

EYU688DRUG

EYU688 administered by oral route

EYU688
PlaceboDRUG

Matching placebo administered orally as capsules

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Novartis Investigative Site

Manaus, Amazonas, 69040-000, Brazil

RECRUITING

Novartis Investigative Site

Brasília, Federal District, 71635-580, Brazil

RECRUITING

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

RECRUITING

Novartis Investigative Site

Sorocaba, São Paulo, 18040-425, Brazil

RECRUITING

Novartis Investigative Site

Sao Jose Rio Preto, 15090 000, Brazil

RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, 080012, Colombia

RECRUITING

Novartis Investigative Site

Bucaramanga, Santander Department, 681017, Colombia

RECRUITING

Novartis Investigative Site

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Novartis Investigative Site

Belagavi, Karnataka, 590010, India

RECRUITING

Novartis Investigative Site

Mumbai, Maharashtra, 400008, India

WITHDRAWN

Novartis Investigative Site

Pune, Maharashtra, 411013, India

RECRUITING

Novartis Investigative Site

Jaipur, Rajasthan, 302017, India

RECRUITING

Novartis Investigative Site

Chennai, Tamil Nadu, 600113, India

RECRUITING

Novartis Investigative Site

Kuantan, Pahang, 25200, Malaysia

RECRUITING

Novartis Investigative Site

Ipoh, Perak, 30450, Malaysia

RECRUITING

Novartis Investigative Site

Seberang Jaya, Pulau Pinang, 13700, Malaysia

RECRUITING

Novartis Investigative Site

Miri, Sarawak, 98000, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Selangor, 68000, Malaysia

RECRUITING

Novartis Investigative Site

Singapore, 169608, Singapore

RECRUITING

Novartis Investigative Site

Singapore, S308433, Singapore

RECRUITING

Novartis Investigative Site

Haiphong, 180000, Vietnam

RECRUITING

Novartis Investigative Site

Hanoi, 100000, Vietnam

RECRUITING

Novartis Investigative Site

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

February 20, 2024

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations

SG(2)BR(5)CO(3)VN(3)MY(5)IN(5)