A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants

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

Trial Summary

What is the purpose of this trial?

This trial is testing a drug called JNJ-64281802 to see if it can lower the amount of dengue virus in patients' bodies. The study focuses on people infected with dengue virus type 1. The goal is to see if this drug can reduce the severity of their infection by decreasing the virus levels.

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.

What data supports the effectiveness of the drug JNJ-64281802?

The research mentions that similar drugs, like tofacitinib and upadacitinib, which are also Janus kinase inhibitors, have shown effectiveness in treating conditions like ankylosing spondylitis and Crohn's disease. This suggests that JNJ-64281802, being in the same class, might also be effective for similar conditions. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

Interventions

• JNJ-64281802

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. [2022]

2. United States 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. [2022]

3. England 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. [2023]

5. United States 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. [2021]