JNJ-64281802 for Dengue

No longer recruiting at 1 trial location

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Allergies, Pregnancy, Investigational study, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how effectively the new drug, JNJ-64281802, reduces the amount of dengue virus in the body. Participants will receive either a placebo (a pill with no active drug) or varying doses of the actual drug. The trial seeks healthy individuals without serious health issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-64281802 was safe and well-tolerated in past studies. These studies tested various doses and found no serious safety issues. Participants did not report any major side effects. Some common concerns with this treatment include a risk of infections, such as tuberculosis and shingles, and possible blood clots or heart issues. However, these risks were uncommon. JNJ-64281802 has undergone extensive testing to ensure its safety for people. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-64281802 because it offers a fresh approach to fighting dengue fever, specifically targeting Dengue Serotype 1 infection. Most current treatments focus on symptom relief and supportive care, as there is no specific antiviral treatment for dengue. JNJ-64281802 is unique because it is an experimental antiviral drug that aims to directly combat the virus itself, potentially offering a more targeted and effective treatment option. The drug is being tested in various dosing regimens, which allows researchers to explore the most effective way to administer it. This approach could pave the way for a groundbreaking treatment in a field with limited options, providing hope for better management of dengue infections.

What evidence suggests that this trial's treatments could be effective for reducing dengue virus 1 viral load?

Research has shown that JNJ-64281802 may help reduce the amount of dengue virus in the body. This treatment is being developed to prevent and treat dengue infections. Earlier studies found that JNJ-64281802 is generally safe and well tolerated by participants. While it works against all types of dengue, this study focuses on its effectiveness against dengue type 1. By lowering virus levels, the drug aims to reduce the severity of the infection. These early results suggest it could be a useful option for managing dengue. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents and initialed and dated by the investigator Must pass the comprehension test (i.e., obtain a passing score of greater than or equal to (>=) 75 percent (%), with up to 3 attempts in total) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and answered the potential participant's questions

Must have a blood pressure (after the participant is supine for >=5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and less than or equal to (<=) 90 mmHg diastolic at screening. Two repeat measurements are allowed in the absence of any other concerning health screening issues

Must have a Body mass index (BMI) (weight in kilogram divided by the square of height in meters) between 18.0 and 33.0 kilogram per meter square (kg/m^2), extremes included, and a body weight of >=50.0 kg at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeated oral doses of JNJ-64281802 or placebo to evaluate antiviral activity against Dengue Serotype 1

4 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of viral load and adverse events

Up to 12 weeks

Regular visits for safety assessments and blood tests

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-64281802

How Is the Trial Designed?

Group I: JNJ-64281802 Medium dose Experimental Treatment 1 Intervention

Participants will receive medium dose of JNJ-64281802 orally.

Group II: JNJ-64281802 Low dose Experimental Treatment 1 Intervention

Participants will receive low dose of JNJ-64281802 orally.

Group III: JNJ-64281802 High dose Experimental Treatment 1 Intervention

Participants will receive high dose of JNJ-64281802 orally.

Group IV: JNJ-64281802 Dosing Regimen Z Experimental Treatment 1 Intervention

Participants will receive dosing regimen Z of JNJ-64281802 orally.

Group V: JNJ-64281802 Dosing Regimen Y Experimental Treatment 1 Intervention

Participants will receive dosing regimen Y of JNJ-64281802 orally.

Group VI: JNJ-64281802 Dosing Regimen X Experimental Treatment 1 Intervention

Participants will receive dosing regimen X of JNJ-64281802 orally.

Group VII: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo of JNJ-64281802 orally.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a 16-week study involving 207 adult patients with active ankylosing spondylitis, tofacitinib at doses of 5 mg and 10 mg twice daily showed significantly greater efficacy in improving symptoms compared to placebo, with the 5 mg dose achieving an ASAS20 response rate of 80.8%.

The safety profile of tofacitinib was comparable to placebo, with no unexpected adverse events, and any dose-dependent laboratory changes returned to baseline by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. van der Heijde, D., Deodhar, A., Wei, JC., et al.[2022]

In a phase 3 trial involving 314 patients with active non-radiographic axial spondyloarthritis, upadacitinib demonstrated a significant improvement in symptoms compared to placebo, with a 22% higher response rate at week 14 (45% vs 23%).

The safety profile of upadacitinib was comparable to placebo, with similar rates of adverse events and no serious infections or major complications reported, indicating it is a safe treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Deodhar, A., Van den Bosch, F., Poddubnyy, D., et al.[2022]

In the CELEST phase 2 study involving adult patients with moderate to severe Crohn's disease, upadacitinib significantly improved health-related quality of life, with 49%-57% of patients achieving a meaningful response in the Inflammatory Bowel Disease Questionnaire (IBDQ) at the 6 mg BID dose or higher, compared to only 24% for placebo.

Patients receiving upadacitinib also showed sustained improvements in work productivity and overall well-being, as measured by the EQ-5D VAS and WPAI questionnaires, particularly notable in the 12 mg BID group over the 52-week study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease. Peyrin-Biroulet, L., Louis, E., Loftus, EV., et al.[2021]

Tofacitinib at doses of 3 mg or higher taken twice daily showed significant efficacy in treating active rheumatoid arthritis, with ACR20 response rates reaching up to 71.9% by week 12, compared to 22.0% for placebo.

The treatment was generally well-tolerated, with manageable side effects, the most common being urinary tract infections and diarrhea, indicating a favorable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Fleischmann, R., Cutolo, M., Genovese, MC., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05201794

A Study of JNJ-64281802 for the Prevention of Dengue ... The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) ...

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-to-discontinue-phase-2-field-study-evaluating-investigational-antiviral-for-the-prevention-of-dengue

Johnson & Johnson to Discontinue Phase 2 Field Study ... Mosnodenvir (formerly JNJ-1802) was shown to be safe and well tolerated in previous Phase 1 and Phase 2a clinical studies. Results from the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10506772/

Safety, Tolerability, and Pharmacokinetics of JNJ-1802, a ... This first-in-human, double-blind, randomized, placebo-controlled study demonstrates that increasing single and multiple oral doses of JNJ-1802, a pan-serotype ...

4. trialx.com trialx.com/clinical-trials/listings/225807/an-evaluation-of-repeated-oral-doses-of-jnj-64281802-against-denv-3-challenge/

An Evaluation of Repeated Oral Doses of JNJ-64281802 ... Overview. The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04906980

NCT04906980 | A Study of JNJ-64281802 in Participants ... 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 ...

6. withpower.com withpower.com/trial/phase-3-dengue-9-2021-e6150

JNJ-64281802 for Dengue Fever · Info for Participants Common safety concerns include an increased risk of infections, such as tuberculosis and herpes zoster (shingles), and potential risks for blood clots and heart ...