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NCT04204616 · ClinicalTrials.gov registry record · Phase 3
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
A Phase 3 study of Prurigo Nodularis, sponsored by Galderma R&D.
- Active
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT04204616: Active Phase 3 study of Prurigo Nodularis, sponsored by Galderma R&D.
NCT04204616 is a Phase 3 study of Prurigo Nodularis that is active but no longer recruiting, run by Galderma R&D. The registered enrollment target is 500 participants, above the 194-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (158% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04204616, a Phase 3 study of Prurigo Nodularis, is active but no longer recruiting, sponsored by Galderma R&D.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
Primary Outcome
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, requ
Conditions Studied
Interventions
- DRUG Nemolizumab
Study Locations (20)
Florida
- Galderma Investigational Site - Aventura
- Galderma Investigational Site - Delray Beach
- Galderma Investigational Site - Hollywood
- Galderma Investigational Site - Largo
- Galderma Investigational Site - Miami
- Galderma Investigational Site - Miami
- Galderma Investigational Site - North Miami Beach
- Galderma Investigational Site - Ormond Beach
- Galderma Investigational Site - Pembroke Pines
- Galderma Investigational Site - Tampa
California
- Galderma Investigational Site - Fountain Valley
- Galderma Investigational Site - Los Angeles
- Galderma Investigational Site - San Diego
- Galderma Investigational Site - San Diego
- Galderma Investigational Site - Santa Monica
Alabama
- Galderma Investigational Site - Birmingham
- Galderma Investigational Site - Birmingham
Georgia
- Galderma Investigational Galderma Investigational Site - Columbus
- Galderma Investigational Site - Macon
District of Columbia
- Galderma Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 3 |
What the registry record for NCT04204616 still lists
NCT04204616 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (158% higher).
The record links to 1 condition, with Prurigo Nodularis appearing as the primary indexed condition, and to 1 intervention - of which Nemolizumab is the first listed.
NCT04204616 names 20 study sites across 5 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04204616 about?
NCT04204616 is a clinical study titled "A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)". The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
What is the current status of trial NCT04204616?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2021-01-11. Estimated completion is 2026-10-26.
What conditions does trial NCT04204616 study?
This clinical trial studies the following conditions: Prurigo Nodularis.
What interventions are being tested in trial NCT04204616?
The interventions under investigation include: Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT04204616?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04204616 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prurigo Nodularis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04204616's enrollment target sits among peer trials
500 2nd of 14 the highest of 14 other Prurigo Nodularis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prurigo Nodularis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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