DenguePhase 2NCT06006559
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
A Phase 2 study testing EYU688 in people with Dengue, run by Novartis Pharmaceuticals at 27 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dengue
- What is being tested?
- EYU688
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 20 Feb 2024to 30 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 20Show fewer
- 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.
Trial locations and contacts
27 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
27 sites in 7 countries
Brazil7 sites, 7 recruiting
- Recruiting
Novartis Investigative Site
Brasília, Federal District, 71635-580
- Recruiting
Novartis Investigative Site
Manaus, Amazonas, 69040-000
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-032
- Recruiting
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21040-360
- Recruiting
Novartis Investigative Site
São Caetano do Sul, São Paulo, 09521-160
- Recruiting
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000
- Recruiting
Novartis Investigative Site
Sorocaba, São Paulo, 18040-425
India5 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Belagavi, Karnataka, 590010
- Recruiting
Novartis Investigative Site
Chennai, Tamil Nadu, 600113
- Recruiting
Novartis Investigative Site
Jaipur, Rajasthan, 302017
- Withdrawn
Novartis Investigative Site
Mumbai, Maharashtra, 400008
- Recruiting
Novartis Investigative Site
Pune, Maharashtra, 411013
Malaysia5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Ipoh, Perak, 30450
- Recruiting
Novartis Investigative Site
Kuala Selangor, 68000
- Recruiting
Novartis Investigative Site
Kuantan, Pahang, 25200
- Recruiting
Novartis Investigative Site
Miri, Sarawak, 98000
- Recruiting
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, 13700
Colombia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080012
- Recruiting
Novartis Investigative Site
Bucaramanga, Santander Department, 681017
- Recruiting
Novartis Investigative Site
Cali, Valle del Cauca Department, 760032
Vietnam3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Haiphong, 180000
- Recruiting
Novartis Investigative Site
Hanoi, 100000
- Recruiting
Novartis Investigative Site
Ho Chi Minh City, 700000
Mexico2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Oaxaca City, 68020
- Recruiting
Novartis Investigative Site
Veracruz, 91855
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, Singapore, 308433
- Recruiting
Novartis Investigative Site
Singapore, 169608
About this study
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
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.
Read the 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]).
- Conditions
- Dengue
- Being tested
- EYU688, Placebo
- Keywords
- Dengue, EYU688
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYU688Drug
EYU688 administered by oral route
PlaceboDrug
Matching placebo administered orally as capsules
| Study group | Role | What they receive |
|---|---|---|
| EYU688 | Experimental | EYU688 administered by oral route Receives: Drug: EYU688 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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℃
Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From inclusion to Day 15
Incidence and severity of Serious Adverse Events (SAEs)
Incidence and severity of SAEs by treatment group
Measured: From inclusion to Day 35
Change of white blood cell count over time from baseline
Assessment of safety and tolerability of EYU688
Measured: From baseline to Day 15
Change of platelet count over time
Assessment of safety and tolerability of EYU688
Measured: From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time
Assessment of safety and tolerability of EYU688
Measured: From baseline to Day 15
Change of AST, ALT levels over time
Assessment of safety and tolerability of EYU688
Measured: From baseline to Day 15
No warning signs by day 7 of fever onset
Assessment of the dengue fever clinical evolution under EYU688
Measured: From inclusion to Day 15
Diagnosis of severe dengue fever
Assessment of the dengue fever clinical evolution under EYU688
Measured: From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)
Assessment of the dengue fever clinical evolution under EYU688
Measured: From inclusion to Day 15
Plasma leakage
Assessment of the dengue fever clinical evolution under EYU688
Measured: From inclusion to Day 15
Requiring fluid infusion
Assessment of the dengue fever clinical evolution under EYU688
Measured: From inclusion to Day 15
Time from fever onset to clinical recovery
Assessment of the dengue fever clinical evolution under EYU688
Measured: From fever onset to Day 15
PK parameter (Cmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Measured: From Day 1 to Day 6
PK parameter (Tmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Measured: From Day 1 to Day 6
PK parameter (partial AUCs)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Measured: From Day 1 to Day 6
PK concentrations following multiple doses
Pharmacokinetic assessment of EYU688 in dengue fever patients
Measured: From Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start20 Feb 2024
- Primary completion22 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006559
- Sponsor's protocol ID
- CEYU688A12201
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 42253092
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06006559
- Acronym / sponsor ID
- CEYU688A12201
- Conditions
- Dengue
- Keywords
- Dengue, EYU688
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYU688 | Experimental | Drug: EYU688EYU688 administered by oral route |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYU688EYU688 administered by oral route | Drug | EYU688 |
| PlaceboMatching placebo administered orally as capsules | Drug | Placebo |
Primary outcome
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
Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.
20 secondary outcomes
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
Diagnosis of dengue hemorrhagic fever (DHF)
Time frame: From inclusion to Day 15
Plasma leakage
Time frame: From inclusion to Day 15
Requiring fluid infusion
Time frame: From inclusion to Day 15
Time from fever onset to clinical recovery
Time frame: From fever onset to Day 15
PK parameter (Cmax)
Time frame: From Day 1 to Day 6
PK parameter (Tmax)
Time frame: From Day 1 to Day 6
PK parameter (partial AUCs)
Time frame: From Day 1 to Day 6
PK concentrations following multiple doses
Time frame: From Day 1 to Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42253092Bouzidi 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EYU688 in people with Dengue, run by Novartis Pharmaceuticals at 27 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Brazil, India, Malaysia, Colombia, Vietnam and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.