Trial · NCT05075408
To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
NCT05075408, Phase 2, Phase 3, Completed, Galderma R&D; results first posted 2025-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus. Trials, record NCT05075408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05075408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
- NCT number
- NCT05075408
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 258 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Chronic Kidney Disease Associated Moderate to Severe Pruritus
- Interventions
- Nemolizumab, Nemolizumab, Placebo
- First posted
- 2021-10-12
- Last updated
- 2026-05-01
- Other registries' IDs
- eudract:2021-004766-35
- Results first posted
- 2025-02-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 | Baseline, Week 12 | Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
| Secondary | Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12 | Baseline, Week 12 | Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
| Secondary | Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4 | Baseline, Week 4 | Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
| Secondary | Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12 | Baseline, Week 12 | Responders are participants with an improvement \>= 4 in SD NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. SD NRS is a scale used by participants to report degree of their sleep loss related to chronic kidney disease with associated pruritus (CKD-aP ). Participants were asked following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
| Secondary | Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 4 | Baseline, Week 4 | Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
| Secondary | Percentage of Responders With an Improvement of SD NRS >= 4 From Baseline at Week 4 | Baseline, Week 4 | Responders are defined as participants with an improvement \>= 4 in SD NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The SD NRS is a scale used by participants to report the degree of their sleep loss related to CKD-aP. Participants were asked the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 | Baseline, Week 12 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12 | Baseline, Week 12 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4 | Baseline, Week 4 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12 | Baseline, Week 12 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 4 | Baseline, Week 4 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders With an Improvement of SD NRS >= 4 From Baseline at Week 4 | Baseline, Week 4 | ITT population consisted of all randomized participants. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 | Nemolizumab 30 mg | 38.5 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 | Nemolizumab 60 mg | 47.7 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12 | Placebo | 32.4 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12 | Nemolizumab 30 mg | 49.3 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12 | Nemolizumab 60 mg | 60.6 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12 | Placebo | 47.1 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4 | Nemolizumab 30 mg | 24.3 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4 | Nemolizumab 60 mg | 26.6 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4 | Placebo | 7.4 | Percentage of Participants | ||
| Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12 | Nemolizumab 30 mg | 27.7 | Percentage of Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nemolizumab 30 mg | 88 | |
| Overall Study | STARTED | Nemolizumab 60 mg | 85 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | COMPLETED | Nemolizumab 30 mg | 72 | |
| Overall Study | COMPLETED | Nemolizumab 60 mg | 71 | |
| Overall Study | COMPLETED | Placebo | 72 | |
| Overall Study | NOT COMPLETED | Nemolizumab 30 mg | 16 | |
| Overall Study | NOT COMPLETED | Nemolizumab 60 mg | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 13 |
Source ClinicalTrials.gov
Adverse events417
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Nemolizumab 30 mg | 1 | 86 | |
| other | COVID-19 | Infections and infestations | Nemolizumab 60 mg | 2 | 84 | |
| other | COVID-19 | Infections and infestations | Placebo | 1 | 85 | |
| other | Nasopharyngitis | Infections and infestations | Nemolizumab 30 mg | 2 | 86 | |
| other | Nasopharyngitis | Infections and infestations | Nemolizumab 60 mg | 0 | 84 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 2 | 85 | |
| other | Pneumonia | Infections and infestations | Nemolizumab 30 mg | 2 | 86 | |
| other | Pneumonia | Infections and infestations | Nemolizumab 60 mg | 1 | 84 | |
| other | Pneumonia | Infections and infestations | Placebo | 1 | 85 | |
| other | Bronchitis | Infections and infestations | Nemolizumab 30 mg | 2 | 86 |
1 to 10 of 417Source ClinicalTrials.gov
See all 417 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nemolizumab 30 mg | 4 | 86 |
| Total, all-cause mortality | Nemolizumab 60 mg | 4 | 84 |
| Total, all-cause mortality | Placebo | 5 | 85 |
| Total, other adverse events | Nemolizumab 30 mg | 29 | 86 |
| Total, other adverse events | Nemolizumab 60 mg | 25 | 84 |
| Total, other adverse events | Placebo | 19 | 85 |
| Total, serious adverse events | Nemolizumab 30 mg | 33 | 86 |
| Total, serious adverse events | Nemolizumab 60 mg | 22 | 84 |
| Total, serious adverse events | Placebo | 27 | 85 |
Source ClinicalTrials.gov
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/NCT05075408
GET https://conductscience.org/api/trials/v1/NCT05075408/events?page=2