Trial · NCT04202679
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
NCT04202679, Phase 3, Completed, Sanofi; results first posted 2022-09-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2). Trials, record NCT04202679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04202679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
- NCT number
- NCT04202679
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Neurodermatitis
- Interventions
- Dupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
- First posted
- 2019-12-17
- Last updated
- 2025-09-17
- Results first posted
- 2022-09-28
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12 | Baseline, Week 12 | WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure. |
| Secondary | Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24 | Baseline, Week 24 | WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure. |
| Secondary | Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24 | At Week 24 | IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported. |
| Secondary | Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24 | Baseline, Week 24 | WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), higher scores indicated more severity. IGA PN-S assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicated greater severity. Percentage of participants with both an improvement (reduction) in WI-NRS by \>=4 Points (from Baseline) and an IGA PN-S score of 0 or 1 were reported in this outcome measure. |
| Secondary | Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12 | At Week 12 | IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported. |
| Secondary | Percent Change From Baseline in WI-NRS Scores at Week 24 | Baseline, Week 24 | WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model. |
| Secondary | Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24 | Baseline, Week 24 | DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model. |
| Secondary | Change From Baseline in Skin Pain-NRS at Week 24 | Baseline, Week 24 | Skin Pain-NRS was used to measure skin pain intensity. Participants were asked daily to rate the intensity of their worst skin pain over the past 24 hours, using a 11-point scale ranging from 0 ("No pain") to 10 ("Worst possible pain"). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model. |
| Secondary | Change From Baseline in Sleep-NRS at Week 24 | Baseline, Week 24 | Sleep-NRS was used to measure sleep intensity. Participants were asked to rate their sleep quality on their past night upon awakening, using a 11-point NRS ranging from 0 to 10, where 0 = worst possible sleep and 10 = best possible sleep. Higher scores indicated less severity. LS means and SE were obtained from ANCOVA model. |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24 | Baseline, Week 24 | HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12 | Baseline, Week 12 | Analysis was performed on intent-to-treat (ITT) population which included all participants with a treatment kit number allocated and recorded in the IRT database analyzed according to the treatment group allocated by randomization regardless of if treatment kit was used or not. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24 | At Week 24 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12 | At Week 12 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in WI-NRS Scores at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Skin Pain-NRS at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sleep-NRS at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24 | Baseline, Week 24 | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12 | Placebo | 22.0 | percentage of participants | ||
| Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12 | Dupilumab 300 mg Q2W | 37.2 | percentage of participants | ||
| Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24 | Placebo | 19.5 | percentage of participants | ||
| Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24 | Dupilumab 300 mg Q2W | 57.7 | percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24 | Placebo | 15.9 | percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24 | Dupilumab 300 mg Q2W | 44.9 | percentage of participants | ||
| Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24 | Placebo | 8.5 | percentage of participants | ||
| Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24 | Dupilumab 300 mg Q2W | 32.1 | percentage of participants | ||
| Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12 | Placebo | 12.2 | percentage of participants | ||
| Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12 | Dupilumab 300 mg Q2W | 25.6 | percentage of participants |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | STARTED | Dupilumab 300 mg Q2W | 78 | |
| Overall Study | Treated | Placebo | 82 | |
| Overall Study | Treated | Dupilumab 300 mg Q2W | 77 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | COMPLETED | Dupilumab 300 mg Q2W | 72 | |
| Overall Study | NOT COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Dupilumab 300 mg Q2W | 6 |
Source ClinicalTrials.gov
Adverse events24
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 | Nasopharyngitis | Infections and infestations | Placebo | 0 | 82 | 0 |
| other | Nasopharyngitis | Infections and infestations | Dupilumab 300 mg Q2W | 4 | 77 | 4 |
| other | Headache | Nervous system disorders | Placebo | 5 | 82 | 9 |
| other | Headache | Nervous system disorders | Dupilumab 300 mg Q2W | 4 | 77 | 4 |
| other | Accidental Overdose | Injury, poisoning and procedural complications | Placebo | 5 | 82 | 5 |
| other | Accidental Overdose | Injury, poisoning and procedural complications | Dupilumab 300 mg Q2W | 4 | 77 | 4 |
| serious | Pelvic Inflammatory Disease | Infections and infestations | Placebo | 0 | 82 | 0 |
| serious | Pelvic Inflammatory Disease | Infections and infestations | Dupilumab 300 mg Q2W | 1 | 77 | 1 |
| serious | Pyelonephritis Acute | Infections and infestations | Placebo | 0 | 82 | 0 |
| serious | Pyelonephritis Acute | Infections and infestations | Dupilumab 300 mg Q2W | 1 | 77 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 82 |
| Total, all-cause mortality | Dupilumab 300 mg Q2W | 0 | 77 |
| Total, other adverse events | Placebo | 10 | 82 |
| Total, other adverse events | Dupilumab 300 mg Q2W | 11 | 77 |
| Total, serious adverse events | Placebo | 4 | 82 |
| Total, serious adverse events | Dupilumab 300 mg Q2W | 2 | 77 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dupilumab 300 mg Q2W vs Placebo: deaths from any cause | Trial comparisons |
| Dupilumab 300 mg Q2W 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/NCT04202679
GET https://conductscience.org/api/trials/v1/NCT04202679/registered?page=2