Trial · NCT07074977
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Population Pharmacokinetics (PopPK) Model of the Elimination of nemolizumab During the 16-week Treatment Period Point | From Baseline up to Week 16 | Point Estimate of Population Total Clearance (Cl/F) of nemolizumab will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Distribution of nemolizumab During the 16-week Treatment Period Point | From Baseline up to Week 16 | Point Estimate of Population Volume of Distribution (Vd/F) of nemolizumab will be reported. |
| Primary | Population Pharmacokinetics (PopPK) Model of the Absorption of nemolizumab During the 16-week Treatment Period Point | From Baseline up to Week 16 | Point Estimate of Absorption Rate Constant (Ka) of nemolizumab will be reported. |
| Primary | Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of nemolizumab Systemic Exposure on Pruritus during 16-week Treatment Period | From Baseline up to Week 16 | Point Estimate of population IC50 of nemolizumab, i.e. the drug concentration required to produce 50% of the maximal inhibition of Average Peak Pruritus, will be reported. |
| Secondary | Individual Observed Ctrough Concentrations of nemolizumab | Week 16 | Average of individual observed Ctrough concentrations of nemolizumab at week 16 will be reported. |
| Secondary | Individual Model - derived Ctrough Concentrations of nemolizumab | Week 16 | Average of individual model-derived Ctrough concentrations of nemolizumab at week 16 will be reported. |
| Secondary | Individual Total Clearance (Cl/F) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of Cl/F will be reported. |
| Secondary | Individual Volume of Distribution (Vd/F) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of Vd/F will be reported. |
| Secondary | Individual Absorption Rate Constant (Ka) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of Ka will be reported. |
| Secondary | Individual Maximum Serum Concentration (Cmax) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of Cmax will be reported. |
| Secondary | Individual Time to Reach Maximum Serum Concentration (Tmax) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of Tmax will be reported. |
| Secondary | Individual Area Under the Concentration-time Curve Within a Dosing Interval (AUCtau) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of AUCtau will be reported. |
| Secondary | Terminal Half-life (t1/2) of nemolizumab | From Baseline up to Week 16 | Average of individual model-derived estimates of t1/2 will be reported. |
| Secondary | Change From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) | Up to Week 16 | PP NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Participant will report PP NRS via daily e-PRO diary. |
| Secondary | Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs), AEs Leading to Study Intervention Withdrawal, AEs Leading to Study Discontinuation | From start of study up to follow-up period (Week 24) | AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported. |
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/NCT07074977/registered