Trial record 3 of 5 for:
JNJ-64281802
A Study of JNJ-64281802 for the Prevention of Dengue Infection
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| ClinicalTrials.gov Identifier: NCT05201794 |
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Recruitment Status :
Recruiting
First Posted : January 21, 2022
Last Update Posted : April 24, 2024
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
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) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dengue | Drug: JNJ-64281802 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1850 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for the Prevention of Dengue Infection |
| Actual Study Start Date : | February 22, 2023 |
| Estimated Primary Completion Date : | May 22, 2025 |
| Estimated Study Completion Date : | May 22, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: High-dose JNJ-64281802 regimen (HDR)
Participants will receive JNJ-64281802 400 milligrams (mg) loading dose (LD) twice daily for 48 hours (2 days), followed by JNJ-64281802 150 mg maintenance dose (MD) once daily for 26 days in fed conditions.
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Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens. |
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Experimental: Low-dose JNJ-64281802 regimen (LDR)
Participants will receive JNJ-64281802 150 mg LD twice daily for 48 hours (2 days), followed by JNJ-64281802 50 mg MD once daily for 26 days in fed conditions.
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Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens. |
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Placebo Comparator: Placebo
Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.
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Drug: Placebo
Matching placebo for each dose level as tablet will be administered orally. |
Primary Outcome Measures :
- Number of Participants with Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing Among Participants Who Have No Evidence of Current DENV Infection at Baseline [ Time Frame: Baseline up to Day 28 ]Number of participants with laboratory-confirmed DENV infection between baseline and the last day of dosing among participants who have no evidence of current DENV infection at baseline will be reported. Presence of a laboratory-confirmed DENV infection is defined as a positive DENV ribonucleic acid (RNA) or DENV nonstructural (NS)1 protein test result.
Secondary Outcome Measures :
- Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among All Participants [ Time Frame: Baseline up to Day 28 ]Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and the last day of dosing among all participants will be reported. Laboratory-confirmed symptomatic DENV infection is defined as having at least 2 solicited systemic adverse events (AEs), of which at least one is a most common dengue symptom (that is, fever, headache/retro-orbital pain, myalgia, arthralgia, rash), lasting for greater than or equal to (>=) 1 day and occurring within a plus/minus (+/-) 2 days time window around the positive polymerase chain reaction (PCR) or NS1 test, between baseline and the last day of dosing.
- Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among Participants With No Evidence of Current DENV Infection at Baseline [ Time Frame: Baseline up to Day 28 ]Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and the last day of dosing among participants who have no evidence of current DENV infection at baseline will be reported.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 7 weeks ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 7 weeks ]SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
- Number of Participants with Abnormalities in Physical Examinations [ Time Frame: Up to 7 weeks ]Number of participants with abnormalities in physical examinations (including examination of head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological body systems) will be reported.
- Number of Participants with Abnormalities in Vital Signs [ Time Frame: Up to 7 weeks ]Number of participants with abnormalities in vital signs (including temperature, pulse or heart rate, blood pressure [systolic and diastolic]) will be reported.
- Number of Participants with Abnormalities in Electrocardiograms (ECGs) [ Time Frame: Up to 7 weeks ]Number of participants with abnormalities in ECGs will be reported.
- Number of Participants with Abnormalities in Clinical Laboratory Assessments [ Time Frame: Up to 7 weeks ]Number of participants with abnormalities in clinical laboratory assessments (serum chemistry, hematology and coagulation, and urinalysis) will be reported.
- Area Under the Concentration Curve of JNJ-64281802 During One Dosing Interval (AUCtau) [ Time Frame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose ]AUCtau is defined as area under the concentration curve of JNJ-64281802 during one dosing interval.
- Observed JNJ-64281802 Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) [ Time Frame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose ]Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning or at the end of a dosing interval.
- Maximum Plasma Concentration (Cmax) of JNJ-64281802 [ Time Frame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose ]Cmax is defined as the maximum plasma concentration of JNJ-64281802.
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| Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
- Must have a body mass index (BMI, weight in kilogram [kg] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive, and a body weight of greater than or equal to (>=) 40.0 kg at screening
- A woman must have a negative highly sensitive urine pregnancy test at screening
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for >= 90 days after receiving the last dose of study intervention
- Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion Criteria:
- Having any dengue virus (DENV)-associated clinical signs and symptoms
- Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
- Any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Reduced immune function to be: (a) Known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy)
- Received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 [COVID-19] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05201794
Contacts
| Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations
Show 37 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT05201794 |
| Other Study ID Numbers: |
CR109157 64281802DNG2004 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | January 21, 2022 Key Record Dates |
| Last Update Posted: | April 24, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dengue Infections Mosquito-Borne Diseases Vector Borne Diseases Arbovirus Infections |
Virus Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |