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NCT03689972 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 585
- Enrollment target
NCT03689972: Completed Phase 3 study, sponsored by Biogen.
NCT03689972 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 585 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689972, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 585 participants
- Enrollment target
Study Summary
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks \[Q6W\]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks \[Q4W\]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.
Primary Outcome
T2 hyperintense lesions were analyzed by magnetic resonance imaging (MRI) scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new or newly enlarging T2 hyperintense lesions at Week 72 relative to baseline.
Interventions
- DRUG Natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 585 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 3 |
What the finished NCT03689972 record still lists
NCT03689972 is an interventional study that assigns participants to a tested intervention. The registered 585 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 1 intervention - of which Natalizumab is the first listed.
NCT03689972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03689972 about?
NCT03689972 is a clinical study titled "A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration". Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks \[Q6W\]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks \[Q4W\]) for at least 12 months, in relation to continued Q4...
What is the current status of trial NCT03689972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 585 participants. The study started on 2018-11-27. Estimated completion is 2023-07-24.
What interventions are being tested in trial NCT03689972?
The interventions under investigation include: Natalizumab (DRUG).
Who is sponsoring clinical trial NCT03689972?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03689972's enrollment target sits among peer trials
585 651st of 2000 higher than 1,349 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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