18 and older, any sex, with Generalized Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· From Baseline (Day 1) to End of Study (up to 34 months)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already presen
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
78.4
Rozanolixizumab ~10 mg/kg
94.1
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP)Primary· From Baseline (Day 1) to End of Study (up to 34 months)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
9.8
Rozanolixizumab ~10 mg/kg
16.7
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
The MG-ADL is an 8-item PRO instrument developed on basis of QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0= no symptoms or impaired performance and 3= most severe symptoms or impaired performance. The total score ranges from 0 to 24, with higher score indicating more disability. A positive change in score indicates worsening and negative change indicates improvement. For analyses done by study cycle, Baseline values w
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-3.7
± 3.5
Rozanolixizumab ~10 mg/kg
-3.1
± 2.9
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-2.9
± 3.1
Rozanolixizumab ~10 mg/kg
-3.8
± 3.9
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-3.3
± 2.7
Rozanolixizumab ~10 mg/kg
-3.2
± 3.3
Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement. For the analyses done by study cycle, Baseline values were the last available values prior to or on the sa
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-4.5
± 5.0
Rozanolixizumab ~10 mg/kg
-4.1
± 4.2
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-3.9
± 4.1
Rozanolixizumab ~10 mg/kg
-4.9
± 5.5
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-5.1
± 4.8
Rozanolixizumab ~10 mg/kg
-4.2
± 4.4
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
MG-C scale consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5), lower scores= lower disease activity. Total MG-C score obtained by summing responses to each individual item and score ranges from 0 - 50, (lower scores indicating lower
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-7.6
± 7.3
Rozanolixizumab ~10 mg/kg
-4.7
± 5.7
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-5.7
± 5.4
Rozanolixizumab ~10 mg/kg
-7.5
± 7.0
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-6.8
± 5.9
Rozanolixizumab ~10 mg/kg
-6.1
± 7.2
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular symptoms (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option that best described severity of ocular, bulbar, and respiratory symptoms over past 7 days using a 4-point Likert scale ("none" to "severe") and frequency of experiencing physical fatigue and muscle weakness fatigability over past 7 days using a 5-point Likert scale (1="none of the time" - 5= "all of the time"), for each i
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-17.6
± 21.0
Rozanolixizumab ~10 mg/kg
-14.6
± 17.2
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-13.2
± 19.2
Rozanolixizumab ~10 mg/kg
-19.2
± 21.6
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-12.8
± 14.4
Rozanolixizumab ~10 mg/kg
-15.4
± 17.7
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option based on frequency of experiencing physical fatigue (19-33) over past 7 days using a 5-point Likert scale (1="none of time" - 5="all of time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms.
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-16.5
± 18.6
Rozanolixizumab ~10 mg/kg
-14.8
± 18.5
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-13.6
± 21.6
Rozanolixizumab ~10 mg/kg
-16.0
± 18.2
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-15.3
± 16.9
Rozanolixizumab ~10 mg/kg
-15.0
± 18.4
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Bulbar symptoms are now recognised as bulbar muscle weakness. Study participants were asked to choose response option that best described severity of bulbar muscle weakness (6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-13.4
± 19.8
Rozanolixizumab ~10 mg/kg
-11.6
± 16.2
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-10.4
± 16.2
Rozanolixizumab ~10 mg/kg
-15.5
± 18.1
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
-14.0
± 16.8
Rozanolixizumab ~10 mg/kg
-13.0
± 17.9
MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43])Secondary· Day 43 of Cycle 1, 2, and 3
The MG-ADL is an 8-item PRO instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A MG-ADL responder was defined as achieving at least 2.0-point improve
Cycle 1: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
74.3
Rozanolixizumab ~10 mg/kg
63.6
Cycle 2: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
62.5
Rozanolixizumab ~10 mg/kg
67.7
Cycle 3: Treatment (Day 43)
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
73.2
Rozanolixizumab ~10 mg/kg
67.2
Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3)Secondary· From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)
Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline. Time to first MG-ADL response (in days) by study cycle was defined as date of first MG-ADL Response within study cycle - date of MG-ADL Baseline within study cycle + 1.
Cycle 1
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
9.00
8.00 – 15.00
Rozanolixizumab ~10 mg/kg
22.00
15.00 – 36.00
Cycle 2
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
15.00
10.00 – 17.00
Rozanolixizumab ~10 mg/kg
15.00
9.00 – 22.00
Cycle 3
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
15.00
9.00 – 15.00
Rozanolixizumab ~10 mg/kg
15.00
9.00 – 17.00
Time Between Consecutive Treatment CyclesSecondary· From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years
Time between consecutive treatment cycles: Study participants were assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on MG-ADL or 3.0 points on QMG scale) between assessments, resulted additional treatment, study participants undergone another 6-week treatment cycle followed by an Observation Period, based on Investigator's discretion. Time between treatment cycles was calculated as: date of first sc infusion in consecutive cycle - date of last sc infusion before new cycle + 1 (or date of censoring - date of last sc infusion before
Between Cycle 1 and Cycle 2
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
64.0
9 – 883
Rozanolixizumab ~10 mg/kg
51.0
2 – 856
Between Cycle 2 and Cycle 3
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
58.0
1 – 631
Rozanolixizumab ~10 mg/kg
50.0
15 – 575
Between Cycle 3 and Cycle 4
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
42.5
27 – 399
Rozanolixizumab ~10 mg/kg
43.0
5 – 194
Between Cycle 4 and Cycle 5
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
43.0
9 – 181
Rozanolixizumab ~10 mg/kg
43.0
17 – 242
Between Cycle 5 and Cycle 6
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
44.0
22 – 192
Rozanolixizumab ~10 mg/kg
43.0
15 – 175
Between Cycle 6 and Cycle 7
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
36.0
8 – 348
Rozanolixizumab ~10 mg/kg
43.0
7 – 106
Between Cycle 7 and Cycle 8
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
37.0
22 – 87
Rozanolixizumab ~10 mg/kg
37.0
6 – 84
Between Cycle 8 and Cycle 9
Group
Value
95% CI
Rozanolixizumab ~7 mg/kg
36.0
8 – 120
Rozanolixizumab ~10 mg/kg
36.0
7.0 – 134
Adverse events — posted to ClinicalTrials.gov
Time frame: Enrolled, but not treated: From Screening until End of Study (up to 34 months); Randomized participants: From Baseline (Day 1) until End of Study (up to 34 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465289 — A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gr
· Phase 3
· not yet recruiting
NCT07463521 — A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
· Phase 3
· not yet recruiting
NCT07246564 — Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myastheni
· Phase 4
· recruiting
NCT06720714 — A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
· Phase 1
· completed
NCT05681715 — A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Gen
· Phase 3
· completed
Other recruiting trials for Generalized Myasthenia Gravis
Currently open trials in the same condition.
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen
· Phase 2
· recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
· Phase 4
· recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip
· recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With
· Phase 2
· recruiting
NCT06967480 — Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
· recruiting
Other UCB Biopharma SRL trials
Trials by the same sponsor.
NCT07465289 — A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gr
· Phase 3
· not yet recruiting
NCT07463521 — A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
· Phase 3
· not yet recruiting
NCT07277660 — A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Stu
· Phase 2
· recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu
· Phase 1
· recruiting
NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 18 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04650854.