A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever

NCT04906980 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CR10891964281802DNG2003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the antiviral activity of JNJ-64281802 versus placebo in terms of reduction of dengue virus (DENV) ribonucleic acid (RNA) in primary DENV infection.

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

• Area Under the Log10-Transformed Dengue Virus (DENV) RiboNucleic Acid (RNA) Viral Load (VL) Curve From Baseline Until Day 5 (AUCD1-D5 [log10VL]).

  The antiviral activity of JNJ-64281802 versus placebo in terms of reduction of DENV RNA in participants with a primary DENV infection was planned to be measured by the area under the log10-transformed DENV RNA viral load concentration-time curves from baseline (Day 1) until Day 5 (AUCD1-D5 \[log10VL\]).

  Baseline (Day 1) upto Day 5

Secondary Outcomes (11)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From Day 1 up to the last onsite visit (Day 30)

• Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings

  From Day 1 up to the last onsite visit (Day 30)

• Number of Participants With Clinically Significant Abnormalities in Physical Examination

  From Day 1 up to the last onsite visit (Day 30)

• Number of Participants With Clinically Significant Abnormalities in Vital Signs

  From Day 1 up to the last onsite visit (Day 30)

• Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

  From Day 1 up to the last onsite visit (Day 30)

Study Arms (2)

JNJ-64281802

EXPERIMENTAL

Participants will receive 2 initial loading doses of JNJ-64281802 up to Day 2, followed by a maintenance dose on Days 3, 4, and 5.

Drug: JNJ-64281802

Placebo

PLACEBO COMPARATOR

Participants will receive oral dose of matching placebo every 8 hour (q8h) and once daily on Day 4 and Day 5.

Drug: Placebo

Interventions

JNJ-64281802 DRUG

JNJ-64281802 will be administered orally.

JNJ-64281802

Placebo DRUG

Matching placebo (PEG400) will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant with a referral note/documentation from a health care facility or practitioner indicating non-structural 1 protein (NS1) positive for dengue virus (DENV), positive NS1 rapid test at pre-screening during an ambulatory visit, or participant who tests NS1 positive at the site
• Participant reported a fever with an onset within the last 48 hours
• A woman of childbearing potential must have a negative serum pregnancy test at screening
• A woman must be: a. not of childbearing potential, b. of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than \[\<\] 1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 90 days after last dose- the end of relevant systemic exposure
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

You may not qualify if:

• Participant with any clinical signs and symptoms for severe dengue according to the world health organization (WHO) criteria (such as severe plasma leakage leading to dengue shock syndrome \[DSS\], fluid accumulation with respiratory distress, severe bleeding, sever organ involvement)
• Use of any cytochrome 3A4 (CYP3A4) inducers (example, phenytoin, rifampin), UDP glucuronosyltransferase family 1 member A9 (UGT1A9) inducers (example, rifampin), or substrates for CYP3A4 with a narrow therapeutic range (example, alfentanil, cyclosporin), or sensitive breast cancer resistance protein (BCRP) substrates (example, pravastatin and folic acid) from 14 days before first dose of study drug until 28 days after last dose of study drug. Systemic use of strong CYP3A4 inhibitors (example, clarithromycin, itraconazole) or UGT1A9 inhibitors (example, probenecid, mefenamic acid) from 7 days before first dose of study drug until 28 days after last dose of study drug
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Had major surgery, (example, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Limitations and Caveats

Since feasibility of enrollment was impacted by COVID, sponsor terminated the study. Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and thus no data was reported for efficacy outcome measures.

Results Point of Contact

• Title: GLOBAL MEDICAL LEADER RESPIRATORY INFEC
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

+12153252489

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: January 24, 2022
• Primary Completion: September 24, 2022
• Study Completion: March 21, 2023
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)