Trial · NCT07074977
Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
NCT07074977, Phase 2, Active not recruiting, Galderma R&D
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO). Trials, record NCT07074977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07074977
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
- NCT number
- NCT07074977
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Galderma R&D
- Conditions
- Chronic Pruritus of Unknown Origin
- Interventions
- nemolizumab, Placebo
- First posted
- 2025-07-20
- Last updated
- 2026-07-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07074977
GET https://conductscience.org/api/trials/v1/NCT07074977/registered