Trial · NCT03921411
Outcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 52
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Nemolizumab Serum Concentrations at Week 1-2 | At week 1-2 | The pharmacokinetic (PK) population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Nemolizumab Serum Concentrations at Week 4 | At week 4 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Nemolizumab Serum Concentrations at Week 8 | At week 8 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Nemolizumab Serum Concentrations at Week 12 | At week 12 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Nemolizumab Serum Concentrations at Week 16 | At week 16 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Nemolizumab Serum Concentrations at Week 24 | At week 24 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab | Baseline to week 24 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. | liter/day (L/day) | MEAN |
| PRIMARY | Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab | Baseline to week 24 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | liter | MEAN |
| PRIMARY | Population Lag Time (Tlag) | Baseline to week 24 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | hours | MEAN |
| PRIMARY | First Order Constant of Absorption (ka) | Baseline to week 24 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value | 1/day | MEAN |
| PRIMARY | Maximum Observed Serum Concentration (Cmax) of Nemolizumab | Baseline to week 12 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. | ng/mL | MEAN |
| PRIMARY | Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab | Baseline to week 12 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. | days | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4 | At week 4 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8 | At week 8 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12 | At week 12 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16 | At week 16 | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng/mL | MEAN |
| PRIMARY | Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w) | Pre-dose through 4 weeks post-dose | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | nanogram*day per milliliter (ng*day/mL) | MEAN |
| PRIMARY | Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w) | Pre-dose through 8 weeks post-dose | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng*day/mL | MEAN |
| PRIMARY | Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w) | Pre-dose through 12 week post-dose | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng*day/mL | MEAN |
| PRIMARY | Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w) | Pre-dose through 16 weeks post-dose | PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | ng*day/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03921411/outcomes