Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome (NCT NCT02738450)

Last Updated: 2021-10-15

Results Overview

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. The measure is expressed in Arbitrary Units per mL (AU/mL). AU/mL in a sample is obtained by back-calculation towards the standard curve.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Values at baseline (week 0) and week 50 are reported

Results posted on

2021-10-15

Participant Flow

Twenty subjects were screened (signed the informed consent) but four participants were considered screen failures

Participant milestones

Participant milestones
Measure	ACI-24 300µg Cohort 1: Low dose	ACI-24 1000µg Cohort 2: High dose	Placebo Placebo cohort 1 + cohort 2
Overall Study STARTED	6	6	4
Overall Study COMPLETED	6	4	4
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ACI-24 300µg Cohort 1: Low dose	ACI-24 1000µg Cohort 2: High dose	Placebo Placebo cohort 1 + cohort 2
Overall Study Withdrawal by Subject	0	2	0

Baseline Characteristics

Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2	Screen Failure n=4 Participants Screen failure cohort 1 + cohort 2	Total n=20 Participants Total of all reporting groups
Age, Continuous	33.5 Years STANDARD_DEVIATION 4.6 • n=5 Participants	31.5 Years STANDARD_DEVIATION 4.9 • n=7 Participants	33.0 Years STANDARD_DEVIATION 4.2 • n=5 Participants	34.0 Years STANDARD_DEVIATION 2.6 • n=4 Participants	32.9 Years STANDARD_DEVIATION 4.1 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	20 participants n=21 Participants
BMI	37.0 kg/m^2 STANDARD_DEVIATION 9.9 • n=5 Participants	39.9 kg/m^2 STANDARD_DEVIATION 9.4 • n=7 Participants	43.1 kg/m^2 STANDARD_DEVIATION 12.7 • n=5 Participants	42.8 kg/m^2 STANDARD_DEVIATION 11.6 • n=4 Participants	40.2 kg/m^2 STANDARD_DEVIATION 10.1 • n=21 Participants
KBIT 2: IQ Composite	44.2 IQ score STANDARD_DEVIATION 5.5 • n=5 Participants	49.2 IQ score STANDARD_DEVIATION 9.5 • n=7 Participants	46.0 IQ score STANDARD_DEVIATION 8.0 • n=5 Participants	52.8 IQ score STANDARD_DEVIATION 18.9 • n=4 Participants	47.8 IQ score STANDARD_DEVIATION 10.4 • n=21 Participants

PRIMARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: Modified Intent to Treat Population (mITT)

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value Week 0	632.3 AU/mL (AU: Arbitrary Unit) Standard Deviation 570.9	335.4 AU/mL (AU: Arbitrary Unit) Standard Deviation 157.4	162.8 AU/mL (AU: Arbitrary Unit) Standard Deviation 84.5
Antibody Titer (Serum Anti-Aβ1-42 Free IgG) - Mean Absolute Value Week 50	751.5 AU/mL (AU: Arbitrary Unit) Standard Deviation 825.6	434.3 AU/mL (AU: Arbitrary Unit) Standard Deviation 224.3	153.3 AU/mL (AU: Arbitrary Unit) Standard Deviation 140.7

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered.

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Amyloid Beta 1-40 in Blood - Mean Absolute Value Week 0	81.7 ng/L Standard Deviation 56.6	138.5 ng/L Standard Deviation 41.1	169.5 ng/L Standard Deviation 43.5
Amyloid Beta 1-40 in Blood - Mean Absolute Value Week 50	183.8 ng/L Standard Deviation 18.7	186.2 ng/L Standard Deviation 37.8	181.3 ng/L Standard Deviation 11.2

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Cambridge Neuropsychological Test Automated Battery (CANTAB), Motor Screening Task (MOT) is a cognitive scale to be completed by the subject. Range score from 0 to ∞, lower score means a better outcome

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
CANTAB - MOT Latency Score Week 50	1781.2 score on a scale Standard Deviation 960.4	1046.3 score on a scale Standard Deviation 152.1	1002.1 score on a scale Standard Deviation 138.5
CANTAB - MOT Latency Score week 0	1784.5 score on a scale Standard Deviation 904.4	997.1 score on a scale Standard Deviation 271.8	1024.3 score on a scale Standard Deviation 193.9

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Cambridge Neuropsychological Test Automated Battery (CANTAB), Paired Associate Learning (PAL) is a cognitive scale to be completed by the subject. Range score from 0 to 20, higher score means a better outcome

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
CANTAB - PAL First Attempt Memory Score week 0	8.0 score on a scale Standard Deviation 5.1	9.2 score on a scale Standard Deviation 5.1	7.8 score on a scale Standard Deviation 5.3
CANTAB - PAL First Attempt Memory Score Week 50	7.5 score on a scale Standard Deviation 4.1	6.7 score on a scale Standard Deviation 4.3	9.8 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Brief Praxis Test (BPT) is a cognitive scale to be completed by the subject. Range score from 0 to 80, higher score means better outcome

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Brief Praxis Test (BPT) - Total Score Week 0	72.0 score on a scale Standard Deviation 5.8	73.7 score on a scale Standard Deviation 3.2	73.8 score on a scale Standard Deviation 5.6
Brief Praxis Test (BPT) - Total Score Week 50	75.5 score on a scale Standard Deviation 4.8	77.5 score on a scale Standard Deviation 2.5	76.5 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Vineland II is a behavioral questionnaire to be completed by the study partner of the subject. Range score from 0 to 113, higher score means a better outcome

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Vineland II - Communication Domain Standard Score Week 50	52.2 score on a scale Standard Deviation 11.3	65.2 score on a scale Standard Deviation 9.4	61.0 score on a scale Standard Deviation 6.8
Vineland II - Communication Domain Standard Score Week 0	47.7 score on a scale Standard Deviation 10.2	59.3 score on a scale Standard Deviation 8.5	59.0 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Vineland II - Daily Living Skill - Domain Standard Score Week 0	54.2 score on a scale Standard Deviation 9.9	68.3 score on a scale Standard Deviation 4.1	58.0 score on a scale Standard Deviation 9.3
Vineland II - Daily Living Skill - Domain Standard Score Week 50	55.8 score on a scale Standard Deviation 11.4	72.8 score on a scale Standard Deviation 4.1	61.5 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Vineland II - Socialisation - Domain Standard Score Week 0	64.3 score on a scale Standard Deviation 17.2	77.0 score on a scale Standard Deviation 9.1	59.0 score on a scale Standard Deviation 15.1
Vineland II - Socialisation - Domain Standard Score Week 50	66.7 score on a scale Standard Deviation 16.1	83.0 score on a scale Standard Deviation 10.4	70.3 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported.

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Neuropsychiatric Inventory (NPI) is a behavioral questionnaire to be completed by the study partner of the subject. Range score from 0 to 144, higher score means a worse outcome

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
NPI - Total Score Week 0	4.5 score on a scale Standard Deviation 3.6	0.3 score on a scale Standard Deviation 0.8	8.5 score on a scale Standard Deviation 10.0
NPI - Total Score Week 50	1.5 score on a scale Standard Deviation 2.5	0.3 score on a scale Standard Deviation 0.8	4.0 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Values at baseline (week 0) and week 50 are reported

Population: mITT

All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. Clinical Global Impression of Change (CGIC) is a global assessment to be completed by the investigator.

Outcome measures

Outcome measures
Measure	ACI-24 300µg n=6 Participants Cohort 1: Low dose	ACI-24 1000µg n=6 Participants Cohort 2: High dose	Placebo n=4 Participants Placebo cohort 1 + cohort 2
Clinical Global Impression of Change (CGIC) - Change From Baseline at Week 50 no change	5 Participants	6 Participants	2 Participants
Clinical Global Impression of Change (CGIC) - Change From Baseline at Week 50 Marked improvement	0 Participants	0 Participants	1 Participants
Clinical Global Impression of Change (CGIC) - Change From Baseline at Week 50 Moderate improvement	1 Participants	0 Participants	1 Participants

Adverse Events

ACI-24 300µg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ACI-24 1000µg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Cohort 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Cohort 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Olivier Sol

AC Immune

Phone: +41 21 345 91 21

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution may freely publish and disseminate the results of the Study. However Institution shall only make a Publication once the Study has been completed. Institution shall send Sponsor any Publication 60 days prior to submission and Sponsor may make editorial changes to the Publication. Institution shall delete information that Sponsor considers as Confidential and Institution shall delay Publication for an additional 60 days to protect the potential patentability of an invention.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	ACI-24 300µg n=6 participants at risk Cohort 1: Low dose	ACI-24 1000µg n=6 participants at risk Cohort 2: High dose	Placebo Cohort 1 n=2 participants at risk Cohort 1: Placebo	Placebo Cohort 2 n=2 participants at risk Cohort 2: Placebo
Eye disorders Eye disorders	33.3% 2/6 • Number of events 4 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	33.3% 2/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 2/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Vascular disorders	33.3% 2/6 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Psychiatric disorders Psychiatric disorders	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Ear and labyrinth disorders	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 2/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Endocrine disorders Endocrine disorders	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Metabolism and nutrition disorders	16.7% 1/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Surgical and medical procedures Surgical and medical procedures	0.00% 0/6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Infections and infestations	83.3% 5/6 • Number of events 18 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 3/6 • Number of events 14 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Nervous system disorders	50.0% 3/6 • Number of events 5 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 3/6 • Number of events 6 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	50.0% 3/6 • Number of events 4 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 3/6 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastrointestinal disorders	50.0% 3/6 • Number of events 5 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	16.7% 1/6 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	100.0% 2/2 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders General disorders and administration site conditions	33.3% 2/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 2/6 • Number of events 9 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Investigations Investigations	33.3% 2/6 • Number of events 2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	33.3% 2/6 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	100.0% 2/2 • Number of events 3 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	16.7% 1/6 • Number of events 5 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 3/6 • Number of events 7 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	50.0% 1/2 • Number of events 1 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/2 • The collection of Treatment Emergent Adverse Events (TEAEs) for an individual subject started after the first dose at baseline (Week 0) and finished at the end of the designated follow-up period at Week 96. Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.