Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06149559 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Study acronym: roMyG
StatusActive, Not Recruiting
PhasePhase 2/3
Started2024-06-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 56 days later Aug 10, 2026 → Oct 5, 2026
See other at-risk trials from UCB Biopharma SRL

Amendment history

2026-09-10
Study Status v30
Re-verified, no change to tracked fields
2026-08-25
Study Status v29
Primary completion pushed: 2026-08-10 → 2026-10-05
Completion date2026-10-19→2026-10-05
2026-08-13
Study Status, Contacts/Locations v28
Study sitesdetails revised at 2 of 9 sites
2026-07-30
Study Status, Study Design v27
Enrollment increased: 12 → 14 participants
2026-07-16
Study Status, Contacts/Locations v26
Trial sites reduced: 13 → 9 locations
2026-07-02
Study Status v25
Re-verified, no change to tracked fields
2026-06-24
Study Status, Study Design, Contacts/Locations v24
Trial status changed: Recruiting → Active, Not Recruiting
Primary completion pushed: 2026-06-08 → 2026-08-10
Completion pushed: 2026-08-17 → 2026-10-19
Study sites14→13
2026-06-18
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 14 sites
2026-05-07
Study Status, Contacts/Locations v22
Study sites13→14
2026-04-23
Study Status, Contacts/Locations v21
Study sitesdetails revised at 1 of 13 sites
2026-04-09
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 13 sites
2026-03-26
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 13 sites
2026-02-26
Study Status, Contacts/Locations v18
Study sites12→13
2026-01-05
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 12 sites
2025-12-18
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 12 sites
2025-11-06
Study Status, Contacts/Locations v15
Study sites11→12
2025-10-09
Study Status, Contacts/Locations v14
Study sites10→11
2025-09-11
Study Status, Contacts/Locations v13
Study sites9→10
2025-08-28
Study Status, Contacts/Locations v12
Study sites8→9
2025-06-05
Study Status, Contacts/Locations v11
Study sites7→8
2025-05-22
Study Status v10
Re-verified, no change to tracked fields
2025-01-30
Study Status, Contacts/Locations v9
Study sites6→7
2024-12-05
Study Status, Contacts/Locations v8
Study sites5→6
2024-10-10
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 5 sites
2024-08-14
Study Status, Contacts/Locations v6
Study sites5 entries, revised
Mg0006 4015520081
2024-07-04
Study Status, Contacts/Locations v5
Study sites4→5
2024-06-21
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-05-15→confirmed 2024-06-14
Study sites0→4
2024-04-10
Study Status, Oversight, Study Description, Eligibility v3
Start date2024-03→2024-05-15
Eligibility criteria-182 characters
Inclusion Criteria: US specific: - Study participant must be ≥12 to <18 years of age inclusive, at the time of signing the informed consent/assent according to local regulation Rest of world: - Study participant must be ≥2 to <18 years of age inclusive, [...] g the informed consent/assent according to local regulation Global: Study participant must have a documented diagnosis of genera [...]
2024-02-09
Study Status v2
Start date2024-01→2024-03
2023-12-27
Study Status v1
Start date2023-12→2024-01
2023-11-28
Original filing
The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).
Trial Details
NCT Number NCT06149559
Lead Sponsor UCB Biopharma SRL
Conditions Generalized Myasthenia Gravis
Enrollment 14 participants
Start Date 2024-06-14
Primary Completion 2026-10-05 (estimated)
Study Completion 2026-10-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-25