Trial · NCT03921411
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 52
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nemolizumab Serum Concentrations at Week 1-2 | At week 1-2 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Nemolizumab Serum Concentrations at Week 4 | At week 4 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Nemolizumab Serum Concentrations at Week 8 | At week 8 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Nemolizumab Serum Concentrations at Week 12 | At week 12 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Nemolizumab Serum Concentrations at Week 16 | At week 16 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Nemolizumab Serum Concentrations at Week 24 | At week 24 | Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA). |
| Primary | Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab | Baseline to week 24 | CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time \[AUC (0-inf)\]. |
| Primary | Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab | Baseline to week 24 | Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf). |
| Primary | Population Lag Time (Tlag) | Baseline to week 24 | Lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. The population Tlag value was estimated for the overall population and was reported in this endpoint. |
| Primary | First Order Constant of Absorption (ka) | Baseline to week 24 | PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated. |
| Primary | Maximum Observed Serum Concentration (Cmax) of Nemolizumab | Baseline to week 12 | Cmax was obtained from serum concentration time curve. |
| Primary | Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab | Baseline to week 12 | Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data. |
| Primary | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4 | At week 4 | Ctrough is the concentration prior to study drug administration. |
| Primary | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8 | At week 8 | Ctrough is the concentration prior to study drug administration. |
| Primary | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12 | At week 12 | Ctrough is the concentration prior to study drug administration. |
| Primary | Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16 | At week 16 | Ctrough is the concentration prior to study drug administration. |
| Primary | Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w) | Pre-dose through 4 weeks post-dose | Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule. |
| 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 | Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule. |
| 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 | Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule. |
| 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 | Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule. |
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.
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