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NCT04075266 · ClinicalTrials.gov registry record · Phase 2
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 12
- Study locations
NCT04075266: Active Phase 2 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.
NCT04075266 is a Phase 2 study of Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 23 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075266, a Phase 2 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 12
- Study locations
Study Summary
This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.
Primary Outcome
The population PK model was used to simulate concentration-time course and predict individual area under the concentration versus time curve. The data for the PK parameter: area under the concentration versus time curve was collected and analyzed as per body weight range (\<40kg to ≥40 kg).
Conditions Studied
Interventions
- DRUG Ocrelizumab
Study Locations (12)
Other
- Uniwersyteckie Centrum Kliniczne - Gda?sk
- Uniwersytecki Szpital Kliniczny w Poznaniu - Późna
- Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego - Warsaw
- Instytut Pomnik Centrum Zdrowia Dziecka - Warsaw
Lazio
- Ospedale Pediatrico Bambino Gesù - Rome
- Azienda Ospedaliera Sant'Andrea - Rome
Colorado
- University of Colorado Denver Childrens Hospital Rocky Mountain MS Center - Aurora
District of Columbia
- Childrens National Health Center - Washington D.C.
Massachusetts
- Boston Childrens Hospital - Boston
Missouri
- Washington Universtiy school of Medicine - St Louis
Ohio
- Cleveland Clinic - Cleveland
Sicily
- AOU Policlinico V. Emanuele - P.O G. Rodolico - Catania
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-01-09 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 2 |
What the registry record for NCT04075266 still lists
NCT04075266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT04075266 lists 12 locations in 8 states (Other, Lazio, Colorado).
Frequently Asked Questions
What is clinical trial NCT04075266 about?
NCT04075266 is a clinical study titled "A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis". This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of o...
What is the current status of trial NCT04075266?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-01-09. Estimated completion is 2029-12-01.
What conditions does trial NCT04075266 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04075266?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04075266?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04075266 being conducted?
This trial has 12 study locations across Colorado, District of Columbia, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
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 NCT04075266's enrollment target sits among peer trials
23 254th of 315 higher than 61 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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