Trial Outcomes & Findings for An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors (NCT NCT05514873)
NCT ID: NCT05514873
Last Updated: 2025-09-03
Results Overview
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) and up to and including 40 days after the final dose (or last contact depending on which occurs first).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)
Results posted on
2025-09-03
Participant Flow
The study started to enroll participants in October 2022 and concluded in October 2024.
Participant Flow refers to the modified Intention to Treat Population (mITT).
Participant milestones
| Measure |
Zilucoplan 0.3 mg/kg
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
|
Main Treatment Period
STARTED
|
26
|
|
Main Treatment Period
COMPLETED
|
23
|
|
Main Treatment Period
NOT COMPLETED
|
3
|
|
Extension Treatment Period
STARTED
|
23
|
|
Extension Treatment Period
COMPLETED
|
20
|
|
Extension Treatment Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Zilucoplan 0.3 mg/kg
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
|
Main Treatment Period
Subject's lack of compliance with study procedures
|
1
|
|
Main Treatment Period
Adverse Event
|
2
|
|
Extension Treatment Period
Lost to Follow-up
|
3
|
Baseline Characteristics
An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors
Baseline characteristics by cohort
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
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Age, Continuous
|
59.9 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Age, Customized
18 - <65 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
65 - <85 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
>=85 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)Population: The Safety Set (SS) included all study participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) and up to and including 40 days after the final dose (or last contact depending on which occurs first).
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Over the Main Treatment Period
|
73.1 percentage of participants
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PRIMARY outcome
Timeframe: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)Population: The SS included all study participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as an AE starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first).
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
|
|---|---|
|
Percentage of Participants With TEAEs Leading to Withdrawal of Study Medication Over the Main Treatment Period
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The modified ITT Population (mITT) population included all eligible study participants who received at least 1 post-Baseline dose of study medication and had at least 1 post-Baseline assessment.
The MG-ADL is a brief 8-item interviewer-administered patient-reported outcome (PRO) designed to evaluate MG symptom severity. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents severely decreased ability to perform that function. The total MG-ADL score ranges from 0 to 24, with a higher score indicating more severe impairment. A positive change in score indicates worsening and negative change indicates improvement.
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
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Change From Baseline to Week 12 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
|
-1.15 score on a scale
Interval -2.11 to -0.19
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SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The mITT population included all eligible study participants who received at least 1 post-Baseline dose of study medication and had at least 1 post-Baseline assessment.
The QMG is a standardized and validated quantitative strength scoring system that included 13 items in the following categories: ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. Scoring for each item ranges from no weakness (0) to severe weakness (3), with an overall score range from 0 to 39. Higher scores represent more severe impairment. A positive change in score indicates worsening and negative change indicates improvement.
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
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Change From Baseline to Week 12 in the Quantitative Myasthenia Gravis (QMG) Score
|
-1.24 score on a scale
Interval -2.64 to 0.16
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SECONDARY outcome
Timeframe: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)Population: The SS included all study participants who received at least 1 dose of study medication.
Treatment-emergent serious adverse events (serious TEAEs) were any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment and additionally were emergent untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Required in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Was a congenital anomaly or birth defect * Important medical events
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
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Percentage of Participants With Serious TEAEs Over the Main Treatment Period
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)Population: The mITT population included all eligible study participants who received at least 1 post-Baseline dose of study medication and had at least 1 post-Baseline assessment.
Percentage of participants with study withdrawal based to pre-defined reasons in the protocol were reported.
Outcome measures
| Measure |
Zilucoplan 0.3 mg/kg
n=26 Participants
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
|
Percentage of Participants With Study Withdrawal Over the Main Treatment Period
|
11.5 percentage of participants
|
Adverse Events
Zilucoplan 0.3 mg/kg (Overall Treatment Period)
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zilucoplan 0.3 mg/kg (Overall Treatment Period)
n=26 participants at risk
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
|
Infections and infestations
Diverticulitis
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
COVID-19
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
Pyelonephritis
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
Metapneumovirus infection
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Nervous system disorders
Myasthenia gravis
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Number of events 1 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
Other adverse events
| Measure |
Zilucoplan 0.3 mg/kg (Overall Treatment Period)
n=26 participants at risk
Participants were administered zilucoplan (ZLP) 0.3 milligrams per kilogram per day (mg/kg/day) subcutaneously (SC) once daily (QD) for 12 weeks in Main Treatment Period. Participants who completed the 12-week Main Treatment Period without discontinuing study medication, continued to receive ZLP 0.3 mg/kg/day, SC, once daily in the Extension Treatment Period (up to approximately 84 weeks) until ZLP was commercially available or until further notice from the Sponsor.
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|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
3/26 • Number of events 3 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • Number of events 3 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
General disorders
Pain
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
General disorders
Injection site pain
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
Sinusitis
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Investigations
Amylase increased
|
15.4%
4/26 • Number of events 6 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Investigations
Lipase increased
|
15.4%
4/26 • Number of events 5 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
General disorders
Injection site bruising
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
General disorders
Injection site pruritus
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
Herpes zoster
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
COVID-19
|
15.4%
4/26 • Number of events 4 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Nervous system disorders
Myasthenia gravis
|
11.5%
3/26 • Number of events 4 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • Number of events 2 • From Baseline up to 84 weeks (Overall Treatment Period)
A TEAE was defined as an adverse event (AE) starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first). TEAEs were analyzed and reported for SS. The SS included all study participants who received at least 1 dose of study medication. The Overall Treatment Period is constituted of the Main Treatment Period and Extension Treatment Period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60