Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lumicitabine · 1 trial · 1 indication
Percentage of participants with asthma diagnosed by physician were reported.
Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\*100.
| Arm | Type | Description |
|---|---|---|
| Lumicitabine | EXPERIMENTAL | Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage. |
| Placebo | PLACEBO_COMPARATOR | Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage. |
| Name | Type | Description |
|---|---|---|
| Lumicitabine | DRUG | Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study. |
| Placebo | DRUG | Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study. |
Inclusion Criteria: * Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004 * The p...
Lumicitabine is an investigational small molecule antiviral being developed by Johnson & Johnson for respiratory syncytial virus infections. It is in Phase 2 clinical development and has been studied in infants and children with a history of RSV infection. It is not an approved medicine.
Lumicitabine is being studied for respiratory syncytial virus infections, specifically in infants and children with a history of RSV infection. The research has focused on the long-term impact of the drug on the incidence of asthma and wheezing in this pediatric population.
Lumicitabine is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical program evaluating the drug in respiratory syncytial virus infections.
Lumicitabine is in Phase 2 clinical development. It is an investigational small molecule and has not been approved for any indication. One Phase 2 trial has been completed, and no trials are currently listed as active.
Lumicitabine has been evaluated in one completed Phase 2 trial, NCT03332459. The study was a long-term follow-up investigation assessing the impact of lumicitabine on the incidence of asthma and wheezing in infants and children with a history of respiratory syncytial virus infection. It was conducted in Japan.
The completed Phase 2 study, NCT03332459, was a placebo-controlled, double-blind trial. It enrolled 7 participants, was not randomized, and included males and females from 56 days of age. The trial took place in Japan and enrolled no healthy volunteers.