Trial · NCT04501679
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
NCT04501679, Phase 3, Completed, Galderma R&D; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Trials, record NCT04501679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04501679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
- NCT number
- NCT04501679
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Prurigo Nodularis
- Interventions
- Nemolizumab, Placebo
- First posted
- 2020-08-06
- Last updated
- 2024-07-10
- Other registries' IDs
- eudract:2019-004789-17
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Baseline, Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Primary | Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | Baseline, Week 16 | IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Baseline, Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With PP NRS < 2 at Week 16 | Week 16 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Baseline, Week 16 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | Baseline, Week 4 | The SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time) (rounding to nearest whole number is not permitted). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With PP NRS < 2 at Week 4 | Week 4 | The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. If a subject received any rescue therapy, the data at/after receipt of rescue therapy are considered as non-responders. Subjects with missing results are considered as non-responders. |
| Secondary | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | From baseline up to end of treatment period (16 Weeks) | 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 until the last study visit. 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. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Baseline, Week 16 | ITT population consisted of all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | Baseline, Week 16 | ITT population consisted of all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Baseline, Week 4 | ITT population consisted of all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With PP NRS < 2 at Week 16 | Week 16 | ITT population consisted all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Baseline, Week 16 | ITT population consisted all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | Baseline, Week 4 | ITT population consisted of all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With PP NRS < 2 at Week 4 | Week 4 | ITT population consisted all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) | From baseline up to end of treatment period (16 Weeks) | Safety population included all randomized participants who received at least 1 administration of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Nemolizumab | 103 | Participants | ||
| Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Placebo | 19 | Participants | ||
| Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | Nemolizumab | 69 | Participants | ||
| Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | Placebo | 10 | Participants | ||
| Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Nemolizumab | 75 | Participants | ||
| Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Placebo | 7 | Participants | ||
| Number of Participants With PP NRS < 2 at Week 16 | Nemolizumab | 64 | Participants | ||
| Number of Participants With PP NRS < 2 at Week 16 | Placebo | 7 | Participants | ||
| Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Nemolizumab | 95 | Participants | ||
| Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Placebo | 19 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nemolizumab | 183 | |
| Overall Study | STARTED | Placebo | 91 | |
| Overall Study | Treated | Nemolizumab | 183 | |
| Overall Study | Treated | Placebo | 91 | |
| Overall Study | COMPLETED | Nemolizumab | 174 | |
| Overall Study | COMPLETED | Placebo | 88 | |
| Overall Study | NOT COMPLETED | Nemolizumab | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events30
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 | Headache | Nervous system disorders | Nemolizumab | 12 | 183 | 17 |
| other | Headache | Nervous system disorders | Placebo | 4 | 91 | 4 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Nemolizumab | 10 | 183 | 15 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Placebo | 0 | 91 | 0 |
| other | Neurodermatitis | Skin and subcutaneous tissue disorders | Nemolizumab | 7 | 183 | 7 |
| other | Neurodermatitis | Skin and subcutaneous tissue disorders | Placebo | 10 | 91 | 10 |
| serious | Supraventricular tachycardia | Cardiac disorders | Nemolizumab | 1 | 183 | 1 |
| serious | Supraventricular tachycardia | Cardiac disorders | Placebo | 0 | 91 | 0 |
| serious | Atrial flutter | Cardiac disorders | Nemolizumab | 0 | 183 | 0 |
| serious | Atrial flutter | Cardiac disorders | Placebo | 1 | 91 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nemolizumab | 0 | 183 |
| Total, all-cause mortality | Placebo | 0 | 91 |
| Total, other adverse events | Nemolizumab | 29 | 183 |
| Total, other adverse events | Placebo | 13 | 91 |
| Total, serious adverse events | Nemolizumab | 4 | 183 |
| Total, serious adverse events | Placebo | 5 | 91 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nemolizumab vs Placebo: Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16 | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With PP NRS < 2 at Week 4 | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4 | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4 | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With PP NRS < 2 at Week 16 | Trial comparisons |
| Nemolizumab vs Placebo: deaths from any cause | Trial comparisons |
| Nemolizumab vs Placebo: Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16 | 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/NCT04501679
GET https://conductscience.org/api/trials/v1/NCT04501679/events?page=2