Trial · NCT04204616
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
NCT04204616, Phase 3, Active not recruiting, Galderma R&D
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Trials, record NCT04204616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04204616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
- NCT number
- NCT04204616
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Galderma R&D
- Conditions
- Prurigo Nodularis
- Interventions
- Nemolizumab
- First posted
- 2019-12-19
- Last updated
- 2025-11-12
- Other registries' IDs
- eudract:2019-004294-13
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) by Severity | Up to 192 weeks | Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly. |
| Secondary | Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184 | Up to Week 184 | Percentage of participants with an IGA success (defined as IGA of 0 \[Clear\] or 1 \[Almost clear\]) up to Week 184 will be reported. |
| Secondary | Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184 | Baseline up to Week 184 | Percentage of participants with an improvement of \>= 4 from baseline in PP NRS up to Week 184 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percentage of Participants with Low Disease Activity State up to Week 184 | Up to Week 184 | Percentage of participants with low disease activity state (that is, IGA less than or equal to \[\<=\]2) up to Week 184 will be reported. |
| Secondary | Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184 | Up to Week 184 | Prurigo Activity Score (PAS) will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts. Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 184 will be reported. |
| Secondary | Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184 | Up to Week 184 | PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed. Percentage of healed prurigo lesions (PAS item 5b) up to Week 184 will be reported. |
| Secondary | Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184 | Baseline up to Week 184 | Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported. |
| Secondary | Percentage of Participants with PP NRS <2 up to Week 184 | Up to Week 184 | Percentage of participants with PP NRS \<2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percent Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Absolute Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41405008 | DERIVED |
Source PubMed
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/NCT04204616
GET https://conductscience.org/api/trials/v1/NCT04204616/registered?page=2