Trial · NCT03971422

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

NCT03971422, Phase 3, Completed, UCB Biopharma SRL; results first posted 2023-08-21

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. Trials, record NCT03971422. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03971422

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
NCT number: NCT03971422
Status: Completed
Phases: Phase 3
Enrollment: 200 participants, actual
Lead sponsor: UCB Biopharma SRL
Conditions: Generalized Myasthenia Gravis
Interventions: Rozanolixizumab, Placebo
First posted: 2019-06-03
Last updated: 2026-08-20
Other registries' IDs: eudract:2019-000968-18
Results first posted: 2023-08-21

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score	Baseline and Day 43	The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (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 positive change in the score indicates worsening and a negative change indicates improvement.
Secondary	Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43	Day 43	The MG-ADL is an 8-item PRO instrument developed on the basis of the 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 positive change in the score indicates worsening and a negative change indicates improvement. Study participants were classified as responders at Day 43 if the value was at least a 2-point improvement (decrease) from Baseline at Day 43.
Secondary	Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score	Baseline and Day 43	MG-C scale is a validated assessment and scale tests 10 items with individual item being weighted differently. The items included ptosis/upward gaze (range: 0 \[\>45 second\] - 3 \[Immediate\]), double vision on lateral gaze (range: 0 \[\>45 second\] - 4 \[Immediate\]), eye closure (range: 0 \[Normal\] - 2 \[severe weakness\]), talking (range: 0 \[Normal\] - 6 \[difficult to understand speech\]), chewing (range: 0 \[Normal\] - 6 \[gastric tube\]), swallowing (range: 0 \[Normal\] - 6 \[gastric tube\]), breathing (range: 0 \[Normal\] - 9 \[ventilator dependence\]), neck flexion (range: 0 \[Normal\] - 4 \[severe weakness\]), shoulder abduction (range: 0 \[Normal\] - 5 \[severe weakness\]) and hip flexion (range: 0 \[Normal\] - 5 \[severe weakness\]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.
Secondary	Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score	Baseline and Day 43	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.
Secondary	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score	Baseline and Day 43	MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Secondary	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score	Baseline and Day 43	The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose the response option that how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Secondary	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score	Baseline and Day 43	The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that best described severity of bulbar muscle weakness (items 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 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From Baseline until End of Study Visit (up to Week 14)	A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) up to and including 8 weeks after the last dose.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)	From Baseline until End of Study Visit (up to Week 14)	A TEAE is defined as an AE starting on or after the time of first administration of IMP up to and including 8 weeks after the last dose.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43	Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	percentage of participants	NUMBER
SECONDARY	Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score	Baseline and Day 43	The Randomized Set consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From Baseline until End of Study Visit (up to Week 14)	The Safety Set consisted of all randomized study participants who received at least one dose of IMP and were analyzed according to the actual treatment the participants received. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)	From Baseline until End of Study Visit (up to Week 14)	The Safety Set consisted of all randomized study participants who received at least one dose of IMP and were analyzed according to the actual treatment the participants received. Two participants randomized to RLZ \~7mg/kg, were administered RLZ \~10mg/kg at baseline visit. So, these two participants were included in RLZ \~7 mg/kg group in randomized set, but in RLZ \~10 mg/kg group in safety set.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score	Placebo	-0.784	Standard Error 0.488	units on a scale
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score	Rozanolixizumab ~7 mg/kg	-3.370	Standard Error 0.486	units on a scale
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score	Rozanolixizumab ~10 mg/kg	-3.403	Standard Error 0.494	units on a scale
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43	Placebo	28.4		percentage of participants
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43	Rozanolixizumab ~7 mg/kg	68.2		percentage of participants
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43	Rozanolixizumab ~10 mg/kg	61.2		percentage of participants
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score	Placebo	-2.029	Standard Error 0.917	units on a scale
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score	Rozanolixizumab ~7 mg/kg	-5.930	Standard Error 0.916	units on a scale
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score	Rozanolixizumab ~10 mg/kg	-7.554	Standard Error 0.934	units on a scale
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score	Placebo	-1.915	Standard Error 0.682	units on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	67
Overall Study	STARTED	Rozanolixizumab ~7 mg/kg	66
Overall Study	STARTED	Rozanolixizumab ~10 mg/kg	67
Overall Study	COMPLETED	Placebo	42
Overall Study	COMPLETED	Rozanolixizumab ~7 mg/kg	43
Overall Study	COMPLETED	Rozanolixizumab ~10 mg/kg	43
Overall Study	NOT COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Rozanolixizumab ~7 mg/kg	23
Overall Study	NOT COMPLETED	Rozanolixizumab ~10 mg/kg	24

Source ClinicalTrials.gov

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Placebo	9	67	14
other	Diarrhoea	Gastrointestinal disorders	Rozanolixizumab ~7 mg/kg	16	64	18
other	Diarrhoea	Gastrointestinal disorders	Rozanolixizumab ~10 mg/kg	11	69	18
other	Nausea	Gastrointestinal disorders	Placebo	5	67	12
other	Nausea	Gastrointestinal disorders	Rozanolixizumab ~7 mg/kg	5	64	7
other	Nausea	Gastrointestinal disorders	Rozanolixizumab ~10 mg/kg	8	69	8
other	Vomiting	Gastrointestinal disorders	Placebo	1	67	4
other	Vomiting	Gastrointestinal disorders	Rozanolixizumab ~7 mg/kg	1	64	3
other	Vomiting	Gastrointestinal disorders	Rozanolixizumab ~10 mg/kg	4	69	4
other	Pyrexia	General disorders	Placebo	1	67	1

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	67
Total, all-cause mortality	Rozanolixizumab ~7 mg/kg	0	64
Total, all-cause mortality	Rozanolixizumab ~10 mg/kg	0	69
Total, other adverse events	Placebo	26	67
Total, other adverse events	Rozanolixizumab ~7 mg/kg	40	64
Total, other adverse events	Rozanolixizumab ~10 mg/kg	42	69
Total, serious adverse events	Placebo	6	67
Total, serious adverse events	Rozanolixizumab ~7 mg/kg	5	64
Total, serious adverse events	Rozanolixizumab ~10 mg/kg	7	69

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33219142	DERIVED	PubMed
37059507	RESULT	PubMed
38099334	DERIVED	PubMed
38978809	DERIVED	PubMed
39297052	RESULT	PubMed
40755069	RESULT	PubMed
41205003	RESULT	PubMed
42388397	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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