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Trial Outcomes & Findings for Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia (NCT NCT04403763)

NCT ID: NCT04403763

Last Updated: 2024-02-06

Results Overview

The number of participants who experience one or more TEAE during the treatment period

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Up to 2 days

Results posted on

2024-02-06

Participant Flow

This study was to be conducted in 3 stages (Stage 1, Stage 2a, and Stage 2b) with participants being randomized to different stages with dose cohorts based on criteria. Due to Sponsor decision, the study was terminated before completion. This decision was not taken due to any safety reasons.

Participant milestones

Participant milestones
Measure
Placebo Dose
Administered as a single drop in one or both eyes Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 4: AGN-241622 Dose 1 (Low Dose)
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in each eye AGN-241622: Topical eye drop
Cohort 6: AGN-241622 Dose 3 (High Dose)
Administered as single drop in each eye AGN-241622: Topical eye drop
Stage 1
STARTED
10
9
10
9
0
0
0
Stage 1
COMPLETED
9
8
9
9
0
0
0
Stage 1
NOT COMPLETED
1
1
1
0
0
0
0
Stage 2A
STARTED
9
0
0
0
12
11
10
Stage 2A
COMPLETED
9
0
0
0
12
11
9
Stage 2A
NOT COMPLETED
0
0
0
0
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo Dose
Administered as a single drop in one or both eyes Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 4: AGN-241622 Dose 1 (Low Dose)
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in each eye AGN-241622: Topical eye drop
Cohort 6: AGN-241622 Dose 3 (High Dose)
Administered as single drop in each eye AGN-241622: Topical eye drop
Stage 1
Participant did not dose due to Sponsor decision
1
1
0
0
0
0
0
Stage 1
Early termination due to PK tube failure
0
0
1
0
0
0
0
Stage 2A
Adverse Event
0
0
0
0
0
0
1

Baseline Characteristics

Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo Dose
n=19 Participants
Administered as single drop in one or both eyes Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
n=9 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
n=10 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
n=9 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 4: AGN-241622 Dose 1 (Low Dose)
n=12 Participants
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
n=11 Participants
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 6: AGN-241622 Dose 3 (High Dose)
n=10 Participants
Administered as a single drop in each eye AGN-241622: Topical eye drop
Total
n=80 Participants
Total of all reporting groups
Age, Customized
<=50
8 Participants
n=5 Participants
6 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
6 Participants
n=10 Participants
1 Participants
n=115 Participants
27 Participants
n=6 Participants
Age, Customized
>50
11 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
7 Participants
n=4 Participants
10 Participants
n=21 Participants
5 Participants
n=10 Participants
9 Participants
n=115 Participants
53 Participants
n=6 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
3 Participants
n=4 Participants
7 Participants
n=21 Participants
9 Participants
n=10 Participants
5 Participants
n=115 Participants
52 Participants
n=6 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
2 Participants
n=10 Participants
5 Participants
n=115 Participants
28 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
6 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
5 Participants
n=10 Participants
0 Participants
n=115 Participants
20 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
8 Participants
n=4 Participants
10 Participants
n=21 Participants
6 Participants
n=10 Participants
10 Participants
n=115 Participants
60 Participants
n=6 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Asian
5 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
14 Participants
n=6 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
4 Participants
n=21 Participants
1 Participants
n=10 Participants
4 Participants
n=115 Participants
16 Participants
n=6 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
8 Participants
n=7 Participants
6 Participants
n=5 Participants
5 Participants
n=4 Participants
6 Participants
n=21 Participants
10 Participants
n=10 Participants
5 Participants
n=115 Participants
50 Participants
n=6 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants

PRIMARY outcome

Timeframe: Up to 2 days

Population: The safety population consists of all participants who received at least 1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.

The number of participants who experience one or more TEAE during the treatment period

Outcome measures

Outcome measures
Measure
Stage 1 Placebo Dose
n=9 Participants
Administered as single drop in one eye Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
n=8 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
n=9 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
n=9 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
Ocular
1 participants
7 participants
1 participants
0 participants
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
Non-ocular
2 participants
1 participants
3 participants
0 participants

PRIMARY outcome

Timeframe: 14 Days

Population: The safety population consists of all participants who received at least 1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.

The number of patients who experience one or more TEAE during the treatment period

Outcome measures

Outcome measures
Measure
Stage 1 Placebo Dose
n=9 Participants
Administered as single drop in one eye Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
n=12 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
n=11 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
n=10 Participants
Administered as single drop in one eye AGN-241622: Topical eye drop
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
Ocular
1 participants
0 participants
2 participants
1 participants
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
Non-ocular
0 participants
0 participants
1 participants
1 participants

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Outcome measures

Outcome data not reported

Adverse Events

Stage 1 Placebo Dose

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 1: AGN-241622 Dose 1

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Cohort 2: AGN-241622 Dose 2

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Cohort 3: AGN-241622 Dose 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Stage 2a Placebo Dose

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Cohort 4: AGN-241622 Dose 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cohort 5: AGN-241622 Dose 2

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 6: AGN-241622 Dose 3

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Stage 1 Placebo Dose
n=9 participants at risk
Administered as single drop in one eye Vehicle: Topical eye drop
Cohort 1: AGN-241622 Dose 1
n=8 participants at risk
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 2: AGN-241622 Dose 2
n=9 participants at risk
Administered as single drop in one eye AGN-241622: Topical eye drop
Cohort 3: AGN-241622 Dose 3
n=9 participants at risk
Administered as single drop in one eye AGN-241622: Topical eye drop
Stage 2a Placebo Dose
n=9 participants at risk
Administered as single drop in each eye Vehicle: Topical eye drop
Cohort 4: AGN-241622 Dose 1
n=12 participants at risk
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 5: AGN-241622 Dose 2
n=11 participants at risk
Administered as a single drop in each eye AGN-241622: Topical eye drop
Cohort 6: AGN-241622 Dose 3
n=10 participants at risk
Administered as a single drop in each eye AGN-241622: Topical eye drop
Eye disorders
DRY EYE
0.00%
0/9 • Up to 5 Weeks
12.5%
1/8 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Eye disorders
EYE IRRITATION
0.00%
0/9 • Up to 5 Weeks
25.0%
2/8 • Number of events 2 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Eye disorders
EYE PRURITUS
0.00%
0/9 • Up to 5 Weeks
12.5%
1/8 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Eye disorders
LACRIMATION INCREASED
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
50.0%
4/8 • Number of events 4 • Up to 5 Weeks
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Eye disorders
PHOTOPHOBIA
0.00%
0/9 • Up to 5 Weeks
12.5%
1/8 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Eye disorders
PUNCTATE KERATITIS
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
18.2%
2/11 • Number of events 3 • Up to 5 Weeks
10.0%
1/10 • Number of events 2 • Up to 5 Weeks
Eye disorders
VISION BLURRED
0.00%
0/9 • Up to 5 Weeks
12.5%
1/8 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Investigations
BLOOD BILIRUBIN INCREASED
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
9.1%
1/11 • Number of events 1 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Investigations
BLOOD GLUCOSE DECREASED
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
9.1%
1/11 • Number of events 1 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Investigations
BLOOD GLUCOSE INCREASED
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Investigations
BLOOD PRESSURE DIASTOLIC INCREASED
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Investigations
PROTEIN URINE PRESENT
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
9.1%
1/11 • Number of events 1 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Nervous system disorders
HEADACHE
22.2%
2/9 • Number of events 2 • Up to 5 Weeks
12.5%
1/8 • Number of events 1 • Up to 5 Weeks
11.1%
1/9 • Number of events 1 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
0.00%
0/10 • Up to 5 Weeks
Skin and subcutaneous tissue disorders
DERMATITIS
0.00%
0/9 • Up to 5 Weeks
0.00%
0/8 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/9 • Up to 5 Weeks
0.00%
0/11 • Up to 5 Weeks
10.0%
1/10 • Number of events 2 • Up to 5 Weeks

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Results disclosure agreements

  • Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
  • Publication restrictions are in place

Restriction type: OTHER