Trial · NCT05052983
A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
NCT05052983, Phase 3, Completed, Galderma R&D; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis. Trials, record NCT05052983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05052983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
- NCT number
- NCT05052983
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Prurigo Nodularis
- Interventions
- Nemolizumab, Placebo
- First posted
- 2021-09-22
- Last updated
- 2024-10-08
- Other registries' IDs
- eudract:2021-003928-32
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | Baseline up to Week 24 | Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication |
| Secondary | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Baseline up to Week 24 | IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear). |
| Secondary | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | Baseline up to Week 24 | Pruritus NRS is a scale that is 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 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | Baseline up to Week 24 | ITT population included all randomized participants. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Baseline up to Week 24 | ITT population included all randomized participants. Here, number analyzed signifies participants who were evaluable for given categories. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit | Baseline up to Week 24 | ITT population included all randomized participants. Here, number analyzed signifies participants who were evaluable for given categories. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point, no imputation for missing data. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | Nemolizumab | NA | 95% Confidence Interval NA to NA | Days | |
| Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | Placebo | 112.50 | 95% Confidence Interval 84.00 to 161.00 | Days | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Nemolizumab | At Week 4 | 88.2 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Placebo | At Week 4 | 86.7 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Nemolizumab | At Week 8 | 82.4 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Placebo | At Week 8 | 81.3 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Nemolizumab | At Week 12 | 88.2 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Placebo | At Week 12 | 53.3 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Nemolizumab | At Week 16 | 81.3 | Percentage of Participants | |
| Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit | Placebo | At Week 16 | 27.3 | Percentage of Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nemolizumab | 18 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | Nemolizumab | 14 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Nemolizumab | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events120
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 | Leukopenia | Blood and lymphatic system disorders | Nemolizumab | 0 | 18 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 1 | 16 | |
| other | Atrioventricular block first degree | Cardiac disorders | Nemolizumab | 1 | 18 | |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 0 | 16 | |
| other | Extrasystoles | Cardiac disorders | Nemolizumab | 1 | 18 | |
| other | Extrasystoles | Cardiac disorders | Placebo | 0 | 16 | |
| other | Thyroid cyst | Endocrine disorders | Nemolizumab | 1 | 18 | |
| other | Thyroid cyst | Endocrine disorders | Placebo | 0 | 16 | |
| other | Constipation | Gastrointestinal disorders | Nemolizumab | 1 | 18 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 16 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nemolizumab | 0 | 18 |
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, other adverse events | Nemolizumab | 11 | 18 |
| Total, other adverse events | Placebo | 10 | 16 |
| Total, serious adverse events | Nemolizumab | 2 | 18 |
| Total, serious adverse events | Placebo | 0 | 16 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nemolizumab vs Placebo: deaths from any cause | Trial comparisons |
| Nemolizumab vs Placebo: serious adverse events | Trial comparisons |
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/NCT05052983
GET https://conductscience.org/api/trials/v1/NCT05052983/results?page=2