Trial Outcomes & Findings for A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD) (NCT NCT03972709)
NCT ID: NCT03972709
Last Updated: 2024-03-27
Results Overview
GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
372 participants
Primary outcome timeframe
Baseline, Week 72
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Galegenimab Q4W
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Overall Study
STARTED
|
149
|
75
|
148
|
|
Overall Study
COMPLETED
|
67
|
35
|
72
|
|
Overall Study
NOT COMPLETED
|
82
|
40
|
76
|
Reasons for withdrawal
| Measure |
Galegenimab Q4W
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
7
|
14
|
|
Overall Study
Study Terminated by Sponsor
|
48
|
25
|
50
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
COVID-19
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
2
|
|
Overall Study
Death
|
5
|
1
|
4
|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
|
Overall Study
Subject Expired Due to SAE with Onset Beyond Protocol Reporting Period
|
0
|
1
|
0
|
|
Overall Study
Subject in Nursing Home, Unable to Attend Visit
|
0
|
0
|
1
|
|
Overall Study
Subject Unable to be Contacted
|
0
|
1
|
0
|
|
Overall Study
Subject Discontinuation Due to AEs with Onset Beyond Study Reporting Period
|
0
|
1
|
0
|
|
Overall Study
Subject Moved
|
0
|
1
|
0
|
|
Overall Study
Missed Study Visits
|
1
|
0
|
0
|
Baseline Characteristics
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
78.9 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
78.4 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
78.0 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
78.4 Years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
367 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: Modified intent-to-treat (mITT) population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis.
GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Outcome measures
| Measure |
Galegenimab Q4W
n=138 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=67 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=132 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
|
2.60 mm^2
Standard Error 0.133
|
2.43 mm^2
Standard Error 0.189
|
2.31 mm^2
Standard Error 0.133
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Ocular Adverse Events in the Study Eye
|
49.7 percentage of participants
|
48 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Ocular Adverse Events in the Fellow Eye
|
29.5 percentage of participants
|
20.0 percentage of participants
|
22.3 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Adverse Events
|
57.7 percentage of participants
|
54.7 percentage of participants
|
62.8 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
19.5 Percentage of Participants
|
21.3 Percentage of Participants
|
23 Percentage of Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of \>= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
|
6.7 Percentage of Participants
|
6.7 Percentage of Participants
|
2.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Safety analysis population included all randomized participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.
Outcome measures
| Measure |
Galegenimab Q4W
n=149 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events Leading to Study Discontinuation
|
2.0 Percentage of Participants
|
1.3 Percentage of Participants
|
2.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: mITT population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis.
BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.
Outcome measures
| Measure |
Galegenimab Q4W
n=138 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=67 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=132 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions
|
-3.45 ETDRS letters
Standard Error 1.344
|
-3.54 ETDRS letters
Standard Error 1.974
|
-3.06 ETDRS letters
Standard Error 1.339
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: mITT population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis.
BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.
Outcome measures
| Measure |
Galegenimab Q4W
n=138 Participants
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=67 Participants
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=132 Participants
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart
|
-5.05 ETDRS letter
Standard Error 1.444
|
-5.68 ETDRS letter
Standard Error 2.032
|
-5.88 ETDRS letter
Standard Error 1.456
|
Adverse Events
Galegenimab Q4W
Serious events: 29 serious events
Other events: 53 other events
Deaths: 5 deaths
Galegenimab Q8W
Serious events: 16 serious events
Other events: 21 other events
Deaths: 1 deaths
All Sham
Serious events: 34 serious events
Other events: 38 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Galegenimab Q4W
n=149 participants at risk
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 participants at risk
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 participants at risk
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Choroidal neovascularisation
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoplastic melanoma
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
1/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.67%
1/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Torsade de pointes
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Iridocyclitis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Macular hole
|
1.3%
2/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hypertension
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal artery spasm
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinopathy proliferative
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Uveitis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitritis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.3%
2/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Swelling
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Swelling face
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
2.0%
3/149 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Empyema
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Endophthalmitis
|
1.3%
2/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.3%
2/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vascular graft infection
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.0%
3/148 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
1.3%
2/149 • Number of events 4 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Troponin increased
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Product Issues
Device dislocation
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/149 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.4%
2/148 • Number of events 2 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/149 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive urgency
|
0.67%
1/149 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/148 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Galegenimab Q4W
n=149 participants at risk
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
Galegenimab Q8W
n=75 participants at risk
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
All Sham
n=148 participants at risk
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
10.1%
15/149 • Number of events 19 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
8.0%
6/75 • Number of events 10 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.1%
6/148 • Number of events 9 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Posterior capsule opacification
|
4.0%
6/149 • Number of events 8 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
5.4%
8/148 • Number of events 9 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal haemorrhage
|
4.7%
7/149 • Number of events 8 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
6.7%
5/75 • Number of events 6 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
5.4%
8/148 • Number of events 14 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
7.4%
11/149 • Number of events 12 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
2.0%
3/148 • Number of events 4 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
8.1%
12/149 • Number of events 12 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
0.68%
1/148 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
6.7%
10/149 • Number of events 11 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
6.8%
10/148 • Number of events 10 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
8/149 • Number of events 9 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
3.4%
5/148 • Number of events 5 • From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER