Trial Outcomes & Findings for A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines (NCT NCT05248880)
NCT ID: NCT05248880
Last Updated: 2026-02-18
Results Overview
\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
309 participants
Primary outcome timeframe
Baseline, Day 7 (Double-blind period)
Results posted on
2026-02-18
Participant Flow
A total of 309 participants (ITT population) with moderate to severe glabellar lines (GL) at maximum frown were enrolled, randomized in a 3:1 ratio to receive either AGN-151586 or placebo in the Double-blind Period. For those meeting all the retreatment criteria on Day 43, a single open-label treatment with AGN-151586 was administered on the same day.
Participant milestones
| Measure |
Placebo
Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.
|
AGN-151586
Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Open-Label Period
STARTED
|
0
|
0
|
2
|
73
|
8
|
191
|
|
Open-Label Period
COMPLETED
|
0
|
0
|
0
|
70
|
0
|
189
|
|
Double-Blind Period
STARTED
|
82
|
227
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
COMPLETED
|
75
|
199
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
7
|
28
|
0
|
0
|
0
|
0
|
|
Open-Label Period
NOT COMPLETED
|
0
|
0
|
2
|
3
|
8
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.
|
AGN-151586
Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Double-Blind Period
Lost to Follow-up
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
7
|
21
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject due to Adverse Event
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Double-Blind Period
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Open-Label Period
Withdrawal by Subject
|
0
|
0
|
1
|
3
|
5
|
1
|
|
Open-Label Period
Withdrawal by Subject due to Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 13.08 • n=4 Participants
|
43.2 years
STANDARD_DEVIATION 13.10
|
43.1 years
STANDARD_DEVIATION 13.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=4 Participants
|
181 Participants
|
245 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=4 Participants
|
46 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=4 Participants
|
26 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=4 Participants
|
201 Participants
|
275 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
2 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=4 Participants
|
16 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=4 Participants
|
2 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=4 Participants
|
14 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=4 Participants
|
189 Participants
|
257 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=4 Participants
|
4 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant
0 = None
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant
1 = Mild
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant
2 = Moderate
|
25 Participants
n=4 Participants
|
58 Participants
|
83 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant
3 = Severe
|
57 Participants
n=4 Participants
|
169 Participants
|
226 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator
0 = None
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator
1 = Mild
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator
2 = Moderate
|
25 Participants
n=4 Participants
|
60 Participants
|
85 Participants
n=4 Participants
|
|
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator
3 = Severe
|
57 Participants
n=4 Participants
|
167 Participants
|
224 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7 (Double-blind period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]
|
65.7 percentage of participants
Interval 59.5 to 71.9
|
1.2 percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 7 (Double-blind period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
|
67.9 percentage of participants
Interval 60.7 to 75.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
|
73.6 percentage of participants
Interval 66.8 to 80.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From time of informed consent to end of study; median time on follow-up was 85 days for all groups.Population: Safety population: all participants who were treated with at least 1 dose of study drug. All safety analyses were performed with participants analyzed by their actual treatment received in the DB period/OL period.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
n=2 Participants
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
n=73 Participants
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
n=8 Participants
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
n=191 Participants
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
TESAE
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Any TEAE
|
48 participants
|
19 participants
|
0 participants
|
18 participants
|
0 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Secondary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 8
|
5.3 percentage of participants
Interval 2.4 to 8.2
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 12
|
18.2 percentage of participants
Interval 13.1 to 23.2
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 24
|
34.4 percentage of participants
Interval 28.2 to 40.6
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 36
|
50.2 percentage of participants
Interval 43.6 to 56.7
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 48
|
55.9 percentage of participants
Interval 49.5 to 62.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 7
|
65.7 percentage of participants
Interval 59.5 to 71.9
|
1.2 percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 14
|
23.2 percentage of participants
Interval 17.7 to 28.8
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 21
|
1.3 percentage of participants
Interval 0.0 to 2.8
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 28
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 35
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 43
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 8
|
9.3 percentage of participants
Interval 5.5 to 13.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 12
|
24.2 percentage of participants
Interval 18.6 to 29.8
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 24
|
44.7 percentage of participants
Interval 38.2 to 51.1
|
1.2 percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 36
|
59.0 percentage of participants
Interval 52.5 to 65.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 48
|
65.2 percentage of participants
Interval 59.0 to 71.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 7
|
75.5 percentage of participants
Interval 69.8 to 81.1
|
2.4 percentage of participants
Interval 0.0 to 5.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 14
|
28.2 percentage of participants
Interval 22.3 to 34.1
|
1.2 percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 21
|
2.8 percentage of participants
Interval 0.6 to 5.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 28
|
0.5 percentage of participants
Interval 0.0 to 1.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 35
|
0.5 percentage of participants
Interval 0.0 to 1.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 43
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 8
|
7.5 percentage of participants
Interval 4.1 to 11.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 12
|
21.1 percentage of participants
Interval 15.8 to 26.5
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 24
|
37.1 percentage of participants
Interval 30.8 to 43.4
|
0.2 percentage of participants
Interval 0.0 to 1.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 36
|
53.1 percentage of participants
Interval 46.6 to 59.6
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Hour 48
|
58.6 percentage of participants
Interval 52.2 to 65.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 7
|
69.4 percentage of participants
Interval 63.4 to 75.4
|
1.2 percentage of participants
Interval 0.0 to 3.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 14
|
30.2 percentage of participants
Interval 24.1 to 36.2
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 21
|
4.0 percentage of participants
Interval 1.4 to 6.6
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 28
|
2.6 percentage of participants
Interval 0.6 to 4.7
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 35
|
1.8 percentage of participants
Interval 0.1 to 3.5
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
Day 43
|
0.9 percentage of participants
Interval 0.0 to 2.1
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA]
|
84.9 percentage of participants
Interval 80.1 to 89.6
|
9.8 percentage of participants
Interval 3.3 to 16.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA]
|
69.3 percentage of participants
Interval 63.3 to 75.3
|
13.7 percentage of participants
Interval 6.2 to 21.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=227 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=82 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA]
|
84.7 percentage of participants
Interval 79.9 to 89.5
|
13.4 percentage of participants
Interval 6.0 to 20.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50 were included. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies]
|
61.9 percentage of participants
Interval 54.4 to 69.3
|
7.9 percentage of participants
Interval 1.3 to 14.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data. Responder rate and its 95% confidence interval (CI) were estimated after using multiple imputation for missing data.
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
|
39.8 percentage of participants
Interval 32.3 to 47.3
|
0.3 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 during the Double-Blind Period are reported. Assessments were performed using the 4- grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
|
44.7 percentage of participants
Interval 37.1 to 52.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
|
72.4 percentage of participants
Interval 65.5 to 79.3
|
14.2 percentage of participants
Interval 5.6 to 22.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
|
78.7 percentage of participants
Interval 72.4 to 85.0
|
10.2 percentage of participants
Interval 2.6 to 17.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 24 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies]
|
68.5 percentage of participants
Interval 61.3 to 75.6
|
9.9 percentage of participants
Interval 2.4 to 17.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=164 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=63 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies]
|
86.0 percentage of participants
Interval 80.6 to 91.4
|
7.9 percentage of participants
Interval 1.3 to 14.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 10 (Look Angry). Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=159 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=57 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies]
|
55.9 percentage of participants
Interval 48.2 to 63.6
|
7.0 percentage of participants
Interval 0.4 to 13.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7 (Double-blind Period)Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 5 (Look Less Attractive). Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
AGN-151586
n=160 Participants
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
|
Placebo
n=59 Participants
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
AGN-151586: Intramuscular Injection
Placebo: Intramuscular Injection
|
Placebo/None
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies]
|
48.9 percentage of participants
Interval 41.1 to 56.7
|
8.5 percentage of participants
Interval 1.4 to 15.6
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AGN-151586
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo/None
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/AGN-151586
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AGN-151586/None
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AGN-151586/AGN-151586
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.
|
AGN-151586
n=227 participants at risk
Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.
|
Placebo/None
n=2 participants at risk
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
Placebo/AGN-151586
n=73 participants at risk
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
AGN-151586/None
n=8 participants at risk
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
|
AGN-151586/AGN-151586
n=191 participants at risk
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/82 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.44%
1/227 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/73 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/191 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.
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AGN-151586
n=227 participants at risk
Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.
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Placebo/None
n=2 participants at risk
Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
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Placebo/AGN-151586
n=73 participants at risk
Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
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AGN-151586/None
n=8 participants at risk
Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.
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AGN-151586/AGN-151586
n=191 participants at risk
Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
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|---|---|---|---|---|---|---|
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Nervous system disorders
HEADACHE
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6.1%
5/82 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
3.1%
7/227 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
5.5%
4/73 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
|
1.0%
2/191 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for all groups.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place