Trial Outcomes & Findings for A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease (NCT NCT04658186)
NCT ID: NCT04658186
Last Updated: 2025-10-31
Results Overview
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
COMPLETED
PHASE2
496 participants
Day 0
2025-10-31
Participant Flow
The study started to enroll participants in December 2020 and concluded in September 2024.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Placebo
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
165
|
166
|
165
|
|
Overall Study
COMPLETED
|
154
|
138
|
139
|
|
Overall Study
NOT COMPLETED
|
11
|
28
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
18
|
15
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Participant Not Eligible. Randomized In Error
|
1
|
0
|
1
|
|
Overall Study
Participant is Moving in Another Province
|
0
|
1
|
0
|
|
Overall Study
Non-Compliance
|
0
|
1
|
1
|
|
Overall Study
Site Closure; Participant declined transfer
|
0
|
1
|
0
|
|
Overall Study
Dropout on the Promotor's Decision
|
0
|
0
|
1
|
|
Overall Study
Worsening Symptoms; Participant Withdrew
|
0
|
0
|
1
|
|
Overall Study
PI Decision due to Participant Safety
|
0
|
0
|
1
|
|
Overall Study
Consent Withdrawn by Participant (not due to adverse event)
|
5
|
6
|
3
|
Baseline Characteristics
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=165 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=166 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=165 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Age, Customized
18 years to less than (<) 65 years
|
98 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Age, Customized
65 years to <85 years
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
134 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Mixed
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
136 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
418 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Full analysis set (FAS) included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=156 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=159 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=159 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Day 0
|
34.0 score on a scale
Standard Deviation 13.2
|
33.9 score on a scale
Standard Deviation 16.4
|
30.6 score on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Month 2Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=156 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=144 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 2
|
34.7 score on a scale
Standard Deviation 13.9
|
34.8 score on a scale
Standard Deviation 18.0
|
30.3 score on a scale
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Month 4Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=148 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=143 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 4
|
34.7 score on a scale
Standard Deviation 14.9
|
34.3 score on a scale
Standard Deviation 18.6
|
31.4 score on a scale
Standard Deviation 15.0
|
PRIMARY outcome
Timeframe: Month 6Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=147 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=146 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 6
|
37.9 score on a scale
Standard Deviation 16.0
|
36.6 score on a scale
Standard Deviation 20.0
|
32.9 score on a scale
Standard Deviation 15.7
|
PRIMARY outcome
Timeframe: Month 8Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=155 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=148 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=143 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 8
|
35.6 score on a scale
Standard Deviation 14.3
|
34.6 score on a scale
Standard Deviation 19.7
|
32.9 score on a scale
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: Month 10Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=156 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=141 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=140 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 10
|
35.6 score on a scale
Standard Deviation 13.6
|
33.7 score on a scale
Standard Deviation 18.4
|
33.2 score on a scale
Standard Deviation 15.6
|
PRIMARY outcome
Timeframe: Month 12Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=142 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=140 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 12
|
37.3 score on a scale
Standard Deviation 15.3
|
36.5 score on a scale
Standard Deviation 19.2
|
34.5 score on a scale
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: Month 14Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=154 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=137 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=141 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 14
|
37.1 score on a scale
Standard Deviation 14.6
|
34.8 score on a scale
Standard Deviation 18.8
|
33.9 score on a scale
Standard Deviation 16.9
|
PRIMARY outcome
Timeframe: Month 16Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=139 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=137 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 16
|
37.2 score on a scale
Standard Deviation 15.6
|
35.9 score on a scale
Standard Deviation 19.8
|
33.6 score on a scale
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=138 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=137 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 18
|
37.9 score on a scale
Standard Deviation 15.5
|
35.6 score on a scale
Standard Deviation 18.1
|
34.9 score on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and number analyzed (n) signifies participants who were evaluable at specified timepoints.
MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms.
Outcome measures
| Measure |
Placebo
n=159 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=162 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
MDS-UPDRS Part III Subscale
Month 8
|
23.3 score on a scale
Standard Deviation 10.0
|
22.2 score on a scale
Standard Deviation 12.6
|
21.0 score on a scale
Standard Deviation 10.7
|
|
MDS-UPDRS Part III Subscale
Month 14
|
24.1 score on a scale
Standard Deviation 10.1
|
22.2 score on a scale
Standard Deviation 11.9
|
21.8 score on a scale
Standard Deviation 11.4
|
|
MDS-UPDRS Part III Subscale
Month 16
|
24.3 score on a scale
Standard Deviation 10.1
|
22.8 score on a scale
Standard Deviation 12.3
|
21.7 score on a scale
Standard Deviation 10.7
|
|
MDS-UPDRS Part III Subscale
Day 0
|
22.6 score on a scale
Standard Deviation 9.8
|
21.9 score on a scale
Standard Deviation 11.3
|
20.4 score on a scale
Standard Deviation 9.5
|
|
MDS-UPDRS Part III Subscale
Month 2
|
22.9 score on a scale
Standard Deviation 10.2
|
22.7 score on a scale
Standard Deviation 12.4
|
20.0 score on a scale
Standard Deviation 10.3
|
|
MDS-UPDRS Part III Subscale
Month 4
|
23.1 score on a scale
Standard Deviation 10.5
|
22.5 score on a scale
Standard Deviation 12.7
|
20.7 score on a scale
Standard Deviation 10.6
|
|
MDS-UPDRS Part III Subscale
Month 6
|
24.3 score on a scale
Standard Deviation 10.9
|
23.2 score on a scale
Standard Deviation 12.4
|
21.3 score on a scale
Standard Deviation 10.8
|
|
MDS-UPDRS Part III Subscale
Month 10
|
23.3 score on a scale
Standard Deviation 9.2
|
21.6 score on a scale
Standard Deviation 12.1
|
21.0 score on a scale
Standard Deviation 11.0
|
|
MDS-UPDRS Part III Subscale
Month 12
|
24.1 score on a scale
Standard Deviation 10.0
|
22.8 score on a scale
Standard Deviation 12.0
|
21.8 score on a scale
Standard Deviation 10.5
|
|
MDS-UPDRS Part III Subscale
Month 18
|
24.2 score on a scale
Standard Deviation 10.1
|
23.0 score on a scale
Standard Deviation 11.7
|
22.2 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints.
The early-stage Parkinson's disease (ePD) subscore is derived from a 15-item subset of the MDS-UPDRS Part III (Motor Examination). It includes all rigidity assessments (neck, upper limbs \[right/left\], and lower limbs \[right/left\]) and bradykinesia-related tasks: finger tapping (right/left), hand movements (right/left), pronation-supination of hands (right/left), toe tapping (right/left), and leg agility (right/left). Each item is scored on a 5-point likert scale (0 = no problem to 4 = severe), resulting in a total ePD subscore range of 0 to 60. Higher scores indicate greater motor impairment, while lower scores reflect better motor function.
Outcome measures
| Measure |
Placebo
n=159 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=162 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Day 0
|
13.3 score on a scale
Standard Deviation 7.11
|
12.6 score on a scale
Standard Deviation 7.96
|
11.8 score on a scale
Standard Deviation 6.85
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 6
|
13.9 score on a scale
Standard Deviation 7.39
|
13.4 score on a scale
Standard Deviation 8.42
|
12.4 score on a scale
Standard Deviation 7.58
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 10
|
13.4 score on a scale
Standard Deviation 6.46
|
12.1 score on a scale
Standard Deviation 8.14
|
11.9 score on a scale
Standard Deviation 7.98
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 12
|
13.7 score on a scale
Standard Deviation 6.98
|
12.7 score on a scale
Standard Deviation 8.20
|
12.9 score on a scale
Standard Deviation 7.61
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 8
|
13.4 score on a scale
Standard Deviation 6.82
|
12.7 score on a scale
Standard Deviation 8.60
|
11.8 score on a scale
Standard Deviation 7.49
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 14
|
13.8 score on a scale
Standard Deviation 7.14
|
12.7 score on a scale
Standard Deviation 8.35
|
12.5 score on a scale
Standard Deviation 7.88
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 16
|
13.8 score on a scale
Standard Deviation 7.24
|
12.9 score on a scale
Standard Deviation 8.26
|
12.4 score on a scale
Standard Deviation 7.83
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 18
|
13.8 score on a scale
Standard Deviation 7.34
|
12.9 score on a scale
Standard Deviation 7.90
|
12.6 score on a scale
Standard Deviation 7.61
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 4
|
13.4 score on a scale
Standard Deviation 7.50
|
13.1 score on a scale
Standard Deviation 8.76
|
11.8 score on a scale
Standard Deviation 7.64
|
|
MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items
Month 2
|
13.2 score on a scale
Standard Deviation 7.33
|
13.2 score on a scale
Standard Deviation 8.48
|
11.6 score on a scale
Standard Deviation 7.57
|
SECONDARY outcome
Timeframe: Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints.
MDS-UPDRS part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. Each of the items in the UPDRS is measured on a scale. It included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=163 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=161 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
MDS-UPDRS Part II Subscale
Day 0
|
6.0 score on a scale
Standard Deviation 4.0
|
6.3 score on a scale
Standard Deviation 4.6
|
5.7 score on a scale
Standard Deviation 4.3
|
|
MDS-UPDRS Part II Subscale
Month 6
|
7.7 score on a scale
Standard Deviation 5.1
|
7.7 score on a scale
Standard Deviation 6.2
|
6.7 score on a scale
Standard Deviation 5.0
|
|
MDS-UPDRS Part II Subscale
Month 14
|
7.1 score on a scale
Standard Deviation 4.8
|
7.2 score on a scale
Standard Deviation 5.8
|
7.0 score on a scale
Standard Deviation 5.1
|
|
MDS-UPDRS Part II Subscale
Month 2
|
6.5 score on a scale
Standard Deviation 4.3
|
6.9 score on a scale
Standard Deviation 5.2
|
6.1 score on a scale
Standard Deviation 4.1
|
|
MDS-UPDRS Part II Subscale
Month 4
|
6.8 score on a scale
Standard Deviation 4.6
|
7.1 score on a scale
Standard Deviation 5.4
|
6.4 score on a scale
Standard Deviation 4.5
|
|
MDS-UPDRS Part II Subscale
Month 8
|
7.0 score on a scale
Standard Deviation 4.6
|
7.1 score on a scale
Standard Deviation 5.7
|
6.9 score on a scale
Standard Deviation 4.7
|
|
MDS-UPDRS Part II Subscale
Month 10
|
6.9 score on a scale
Standard Deviation 4.5
|
6.7 score on a scale
Standard Deviation 5.4
|
7.1 score on a scale
Standard Deviation 4.7
|
|
MDS-UPDRS Part II Subscale
Month 12
|
6.9 score on a scale
Standard Deviation 4.9
|
7.3 score on a scale
Standard Deviation 5.5
|
7.3 score on a scale
Standard Deviation 5.1
|
|
MDS-UPDRS Part II Subscale
Month 16
|
7.1 score on a scale
Standard Deviation 5.1
|
7.2 score on a scale
Standard Deviation 5.7
|
6.7 score on a scale
Standard Deviation 4.5
|
|
MDS-UPDRS Part II Subscale
Month 18
|
7.3 score on a scale
Standard Deviation 5.0
|
6.8 score on a scale
Standard Deviation 5.2
|
7.3 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at specified timepoints.
MDS-UPDRS part I include several non-motor aspects of experiences of daily living including cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome during part 1A and sleep problems, daytime sleepiness, pain and other sensation, urinary problems, constipation problems, lightheadedness on standing, and fatigue during Part 1B. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by participant (Range 0-28). Each of items in UPDRS is measured on a scale of 0 to 4, where 0 is normal and 4 (higher score) represents severe abnormalities/worse outcome. Total Score Range 0 to 52. Total score is sum of Part IA (0-24) and Part IB (0-28) subscale scores. Higher scores indicated greater severity of non-motor symptoms.
Outcome measures
| Measure |
Placebo
n=158 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=161 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=158 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
MDS-UPDRS Part I Subscale
Month 4
|
5.1 score on a scale
Standard Deviation 4.4
|
5.0 score on a scale
Standard Deviation 4.0
|
4.5 score on a scale
Standard Deviation 3.8
|
|
MDS-UPDRS Part I Subscale
Day 0
|
5.4 score on a scale
Standard Deviation 3.9
|
5.5 score on a scale
Standard Deviation 4.4
|
4.7 score on a scale
Standard Deviation 3.7
|
|
MDS-UPDRS Part I Subscale
Month 2
|
5.2 score on a scale
Standard Deviation 4.2
|
5.2 score on a scale
Standard Deviation 3.8
|
4.3 score on a scale
Standard Deviation 3.5
|
|
MDS-UPDRS Part I Subscale
Month 6
|
5.9 score on a scale
Standard Deviation 4.8
|
5.7 score on a scale
Standard Deviation 4.5
|
5.1 score on a scale
Standard Deviation 3.9
|
|
MDS-UPDRS Part I Subscale
Month 8
|
5.5 score on a scale
Standard Deviation 4.4
|
5.3 score on a scale
Standard Deviation 4.2
|
5.0 score on a scale
Standard Deviation 3.9
|
|
MDS-UPDRS Part I Subscale
Month 10
|
5.4 score on a scale
Standard Deviation 4.2
|
5.4 score on a scale
Standard Deviation 4.1
|
4.9 score on a scale
Standard Deviation 4.1
|
|
MDS-UPDRS Part I Subscale
Month 12
|
6.2 score on a scale
Standard Deviation 5.1
|
6.2 score on a scale
Standard Deviation 4.8
|
5.3 score on a scale
Standard Deviation 4.4
|
|
MDS-UPDRS Part I Subscale
Month 14
|
5.9 score on a scale
Standard Deviation 4.6
|
5.8 score on a scale
Standard Deviation 5.0
|
5.0 score on a scale
Standard Deviation 4.2
|
|
MDS-UPDRS Part I Subscale
Month 16
|
5.9 score on a scale
Standard Deviation 4.8
|
5.9 score on a scale
Standard Deviation 5.1
|
5.1 score on a scale
Standard Deviation 4.1
|
|
MDS-UPDRS Part I Subscale
Month 18
|
6.4 score on a scale
Standard Deviation 5.1
|
5.9 score on a scale
Standard Deviation 4.6
|
5.3 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment.
The participant was considered to have an emerging symptom for the item, if the change from Baseline for the item is greater than 0 for 2 consecutive visits. The magnitude of change from Baseline was not considered to determine the emerging symptom. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II includes motor items assessing speech, saliva and drooling, chewing and swallowing, eating tasks (cutting food and handling utensils), dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, a car or a deep chair, walking and balance, and freezing. This included 13-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II was 0-52, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=164 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 3
|
37 Participants
|
15 Participants
|
26 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 0
|
28 Participants
|
36 Participants
|
38 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 1
|
18 Participants
|
41 Participants
|
31 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 2
|
35 Participants
|
33 Participants
|
23 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 4
|
15 Participants
|
13 Participants
|
15 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 5
|
15 Participants
|
13 Participants
|
14 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 6
|
4 Participants
|
7 Participants
|
10 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 7
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 8
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 9
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 11
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II
Number of Emerging symptoms: 13
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment.
Time to worsening of the disease on the MDS-UPDRS III scale as defined by a 5-point increase in MDS-UPDRS III, within the 18-month period. MDS-UPDRS part III includes motor items assessing speech, facial expression, rigidity, finger tapping, hand movements, pronation supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. It included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=164 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Time to Worsening of the Disease as Measured by MDS-UPDRS Part III
|
8.64 months
Interval 7.7236 to 9.5635
|
8.95 months
Interval 7.8974 to 10.0012
|
9.45 months
Interval 8.4743 to 10.434
|
SECONDARY outcome
Timeframe: Screening, Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, 'n' signifies participants who were evaluable at each specified timepoints.
The Montreal Cognitive Assessment (MoCA) is a standardized screening tool used to evaluate mild cognitive impairment across multiple cognitive functions i.e. visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total possible score is calculated by summing the scores across all functions ranges from: 0 to 30. A score of 26 or above is considered normal, a lower score indicates cognitive impairment.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=164 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Screening
|
27.8 score on a scale
Standard Deviation 1.8
|
27.6 score on a scale
Standard Deviation 2.0
|
27.8 score on a scale
Standard Deviation 1.7
|
|
Montreal Cognitive Assessment (MoCA)
Month 18
|
27.4 score on a scale
Standard Deviation 2.2
|
27.3 score on a scale
Standard Deviation 2.4
|
27.3 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Screening, Months 12 and 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at each specified timepoints.
The change from screening in mean striatum specific binding ratios (SBR) was assessed by DaT-SPECT using 123I-Ioflupane as radiopharmaceutical. The whole striatum was calculated as the average of the SBR data values for the four following "small" regions: left caudate small, left putamen small, right caudate small and right putamen small. The SBR was calculated for each region with the occipital cortex as a reference region, where a lower SBR indicates worse disease. The following formula was used to calculate this: (Average \[Small region\] - Average \[Occipital region\])/ (Average \[Occipital region\]).
Outcome measures
| Measure |
Placebo
n=140 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=133 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=130 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral putamen small: Month 18
|
-0.208 specific binding ratio
Standard Deviation 0.252
|
-0.150 specific binding ratio
Standard Deviation 0.260
|
-0.179 specific binding ratio
Standard Deviation 0.270
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Whole striatum: Month 12
|
-0.202 specific binding ratio
Standard Deviation 0.215
|
-0.141 specific binding ratio
Standard Deviation 0.194
|
-0.102 specific binding ratio
Standard Deviation 0.254
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Whole striatum: Month 18
|
-0.233 specific binding ratio
Standard Deviation 0.226
|
-0.182 specific binding ratio
Standard Deviation 0.232
|
-0.193 specific binding ratio
Standard Deviation 0.254
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral striatum: Month 12
|
-0.237 specific binding ratio
Standard Deviation 0.262
|
-0.161 specific binding ratio
Standard Deviation 0.246
|
-0.093 specific binding ratio
Standard Deviation 0.294
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral striatum: Month 18
|
-0.260 specific binding ratio
Standard Deviation 0.263
|
-0.211 specific binding ratio
Standard Deviation 0.282
|
-0.194 specific binding ratio
Standard Deviation 0.318
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral striatum: Month 12
|
-0.161 specific binding ratio
Standard Deviation 0.210
|
-0.138 specific binding ratio
Standard Deviation 0.209
|
-0.099 specific binding ratio
Standard Deviation 0.278
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral striatum: Month 18
|
-0.203 specific binding ratio
Standard Deviation 0.214
|
-0.169 specific binding ratio
Standard Deviation 0.237
|
-0.188 specific binding ratio
Standard Deviation 0.259
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral caudate small: Month 12
|
-0.296 specific binding ratio
Standard Deviation 0.380
|
-0.196 specific binding ratio
Standard Deviation 0.352
|
-0.080 specific binding ratio
Standard Deviation 0.485
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral caudate small: Month 18
|
-0.312 specific binding ratio
Standard Deviation 0.383
|
-0.273 specific binding ratio
Standard Deviation 0.390
|
-0.210 specific binding ratio
Standard Deviation 0.439
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Ipsilateral putamen small: Month 12
|
-0.178 specific binding ratio
Standard Deviation 0.260
|
-0.125 specific binding ratio
Standard Deviation 0.255
|
-0.106 specific binding ratio
Standard Deviation 0.219
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral caudate small: Month 12
|
-0.256 specific binding ratio
Standard Deviation 0.328
|
-0.183 specific binding ratio
Standard Deviation 0.332
|
-0.145 specific binding ratio
Standard Deviation 0.363
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral caudate small: Month 18
|
-0.291 specific binding ratio
Standard Deviation 0.330
|
-0.263 specific binding ratio
Standard Deviation 0.370
|
-0.248 specific binding ratio
Standard Deviation 0.398
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral putamen small: Month 12
|
-0.066 specific binding ratio
Standard Deviation 0.190
|
-0.094 specific binding ratio
Standard Deviation 0.223
|
-0.053 specific binding ratio
Standard Deviation 0.304
|
|
Change From Screening in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Mean Striatum Specific Binding Ratios (SBR)
Contralateral putamen small: Month 18
|
-0.115 specific binding ratio
Standard Deviation 0.190
|
-0.076 specific binding ratio
Standard Deviation 0.197
|
-0.128 specific binding ratio
Standard Deviation 0.209
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment.
Time to start of symptomatic treatment (ST) within the 18-month period.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=164 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Time to Start of Symptomatic Treatment (ST)
|
10.58 months
Interval 9.6242 to 11.5456
|
11.59 months
Interval 10.6084 to 12.5623
|
11.80 months
Interval 10.8312 to 12.7735
|
SECONDARY outcome
Timeframe: Month 18Population: FAS included all randomized study participants who received at least a partial dose of study medication, have at least 1 post-Baseline assessment. Here, number of participants analyzed included all participants who were evaluable for this assessment.
Cumulative number of participants on symptomatic treatment (ST) at 18 months are reported.
Outcome measures
| Measure |
Placebo
n=153 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=139 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=140 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Symptomatic Treatment (ST) Intake
|
111 Participants
|
89 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)Population: Safety set included all randomized study participants who receive at least a partial dose of study medication.
An AE is 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 is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=165 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
87.8 percentage of participants
|
86.7 percentage of participants
|
87.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)Population: Safety set included all randomized study participants who receive at least a partial dose of study medication.
Serious adverse event: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=165 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Percentage of Participants With Serious TEAEs
|
5.5 percentage of participants
|
7.9 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)Population: Safety set included all randomized study participants who receive at least a partial dose of study medication.
An AE is 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 is defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=165 Participants
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 Participants
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Percentage of Participants With TEAEs Leading to Participant Withdrawal
|
2.4 percentage of participants
|
10.9 percentage of participants
|
9.8 percentage of participants
|
Adverse Events
Placebo
UCB0599 180 mg/Day
UCB0599 360 mg/Day
Serious adverse events
| Measure |
Placebo
n=164 participants at risk
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=165 participants at risk
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 participants at risk
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/164 • Number of events 2 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 2 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Infectious pleural effusion
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/165 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/164 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.61%
1/165 • Number of events 1 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
0.00%
0/164 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=164 participants at risk
Participants received UCB0599 matching-placebo capsules, orally, from Day 1 up to 18 months during treatment period.
|
UCB0599 180 mg/Day
n=165 participants at risk
Participants received UCB0599 90 milligram (mg) capsules twice daily (BID), for a total daily dose of 180 mg, along with matching placebo capsules BID, administered orally from Day 1 up to 18 months during treatment period.
|
UCB0599 360 mg/Day
n=164 participants at risk
Participants received UCB0599 180 mg capsules twice daily (BID), for a total daily dose of 360 mg, administered orally from Day 1 up to 18 months during treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.9%
8/164 • Number of events 15 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
7.3%
12/165 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
4.9%
8/164 • Number of events 8 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
8/164 • Number of events 10 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
6.1%
10/165 • Number of events 18 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
5.5%
9/164 • Number of events 10 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
14/164 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
4.2%
7/165 • Number of events 7 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
4.9%
8/164 • Number of events 9 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
General disorders
Fatigue
|
7.3%
12/164 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
7.9%
13/165 • Number of events 15 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
4.3%
7/164 • Number of events 7 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
COVID-19
|
21.3%
35/164 • Number of events 38 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
13.3%
22/165 • Number of events 23 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
19.5%
32/164 • Number of events 33 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
15/164 • Number of events 20 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
10.9%
18/165 • Number of events 26 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
7.3%
12/164 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
19/164 • Number of events 20 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
8.5%
14/165 • Number of events 16 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
8.5%
14/164 • Number of events 15 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Infections and infestations
Influenza
|
6.1%
10/164 • Number of events 10 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
3.6%
6/165 • Number of events 7 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
8.5%
14/164 • Number of events 15 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
9/164 • Number of events 9 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
10.3%
17/165 • Number of events 22 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
7.3%
12/164 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
17/164 • Number of events 17 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
9.1%
15/165 • Number of events 19 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
7.3%
12/164 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
19/164 • Number of events 22 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
8.5%
14/165 • Number of events 14 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
2.4%
4/164 • Number of events 4 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Nervous system disorders
Headache
|
9.8%
16/164 • Number of events 17 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
6.7%
11/165 • Number of events 25 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
9.8%
16/164 • Number of events 24 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
9/164 • Number of events 10 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
3.0%
5/165 • Number of events 5 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
6.7%
11/164 • Number of events 11 • From Baseline up to 30 days of safety follow-up after the last dose of the study drug (up to 19 months)
Safety analysis set included all randomized study participants who received at least a partial dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60