Glabellar Lines
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).
Interventions
DRUGAGN-151586
AGN-151586 solution for injection.
DRUGPlacebo
Placebo solution for injection.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
-Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (at least 10 weeks after study intervention).
Exclusion criteria
* Known immunization or hypersensitivity to any botulinum neurotoxin serotype * Any medical condition that may put the participant at increased risk with exposure to AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator * Any brow or eyelid ptosis, as determined by the investigator * Infection or skin disorder at the injection sites * History of facial nerve palsy * Any uncontrolled systemic disease * Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study intervention) * Anticipated need for surgery or overnight hospitalization during the study * Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery) * Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | Baseline (Day 1) through Day 7 | Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug until the end of study (up to 42 days) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention. |
| Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | From first dose of study drug until the end of study (up to 42 days) | Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP. |
| Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | From first dose of study drug until the end of study (up to 42 days) | Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP. |
| Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | From first dose of study drug until the end of study (up to 42 days) | Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: \> 500 msec or change from baseline value: increase of \> 60 msec; QTcF observed value: \> 500 msec or change from baseline value: increase of \> 60 msec. |
| Number of Participants With Anti-drug Antibodies (ADAs) | Up to Day 42 | Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies. |
Countries
United States
Participant flow
Pre-assignment details
A total of 198 participants with moderate to severe glabellar lines (GL) were enrolled and randomized in a 3:1 ratio to receive AGN-151586 in 5 sequential AGN-151586 dose rising cohorts or Placebo in each of the 5 cohorts.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Placebo Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. | 8 |
| Cohort 1: AGN-151586 Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. | 32 |
| Cohort 2: Placebo Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. | 12 |
| Cohort 2: AGN-151586 Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 28 |
| Cohort 3: Placebo Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. | 11 |
| Cohort 3: AGN-151586 Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 27 |
| Cohort 4: Placebo Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. | 10 |
| Cohort 4: AGN-151586 Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 30 |
| Cohort 5: Placebo Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. | 9 |
| Cohort 5: AGN-151586 Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. | 31 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | COVID-19-related reasons | 0 | 0 | 0 | 0 | 1 | 5 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Placebo | Cohort 1: AGN-151586 | Cohort 2: Placebo | Cohort 2: AGN-151586 | Cohort 3: Placebo | Cohort 3: AGN-151586 | Cohort 4: Placebo | Cohort 4: AGN-151586 | Cohort 5: Placebo | Cohort 5: AGN-151586 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 6.24 | 52.8 years STANDARD_DEVIATION 8.85 | 47.0 years STANDARD_DEVIATION 9.39 | 50.9 years STANDARD_DEVIATION 10.1 | 50.1 years STANDARD_DEVIATION 10.63 | 47.5 years STANDARD_DEVIATION 10.53 | 39.0 years STANDARD_DEVIATION 7.94 | 45.3 years STANDARD_DEVIATION 8.06 | 51.1 years STANDARD_DEVIATION 11.37 | 46.4 years STANDARD_DEVIATION 10.3 | 48.3 years STANDARD_DEVIATION 9.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 3 Participants | 4 Participants | 4 Participants | 8 Participants | 3 Participants | 12 Participants | 0 Participants | 7 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 23 Participants | 9 Participants | 24 Participants | 7 Participants | 19 Participants | 7 Participants | 18 Participants | 9 Participants | 24 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 27 Participants | 10 Participants | 24 Participants | 10 Participants | 26 Participants | 10 Participants | 28 Participants | 7 Participants | 26 Participants | 175 Participants |
| Sex: Female, Male Female | 7 Participants | 29 Participants | 12 Participants | 25 Participants | 11 Participants | 24 Participants | 9 Participants | 26 Participants | 9 Participants | 30 Participants | 182 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 32 | 0 / 12 | 0 / 28 | 0 / 11 | 0 / 27 | 0 / 10 | 0 / 30 | 0 / 9 | 0 / 31 |
| other Total, other adverse events | 3 / 8 | 15 / 32 | 7 / 12 | 10 / 28 | 7 / 11 | 9 / 27 | 3 / 10 | 9 / 30 | 1 / 9 | 12 / 31 |
| serious Total, serious adverse events | 0 / 8 | 0 / 32 | 0 / 12 | 0 / 28 | 0 / 11 | 0 / 27 | 0 / 10 | 0 / 30 | 0 / 9 | 0 / 31 |
Outcome results
Primary
Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.
Time frame: From first dose of study drug until the end of study (up to 42 days)
Population: Safety population included all participants who received study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Placebo | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| Cohort 1: AGN-151586 | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 15 Participants |
| Cohort 2: Placebo | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| Cohort 2: AGN-151586 | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 10 Participants |
| Cohort 3: Placebo | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| Cohort 3: AGN-151586 | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 9 Participants |
| Cohort 4: Placebo | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| Cohort 4: AGN-151586 | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 9 Participants |
| Cohort 5: Placebo | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| Cohort 5: AGN-151586 | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | 12 Participants |
Primary
Number of Participants With Anti-drug Antibodies (ADAs)
Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.
Time frame: Up to Day 42
Population: Safety population included all participants who received study intervention. Overall number of participants analyzed are the number of participants available for analyses. Number analyzed indicates the number of participants with data available for analysis for the below categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 1: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 1: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 1: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 2: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 2: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 3: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 3: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 3: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 3: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 4: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 4: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 5: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 0 Participants |
| Cohort 5: Placebo | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
| Cohort 5: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Binding Antibodies | 1 Participants |
| Cohort 5: AGN-151586 | Number of Participants With Anti-drug Antibodies (ADAs) | Neutralizing Antibodies | 0 Participants |
Primary
Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention
Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: \> 500 msec or change from baseline value: increase of \> 60 msec; QTcF observed value: \> 500 msec or change from baseline value: increase of \> 60 msec.
Time frame: From first dose of study drug until the end of study (up to 42 days)
Population: Safety population included all participants who received study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 1: AGN-151586 | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 2: AGN-151586 | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 3: Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 3: AGN-151586 | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 4: AGN-151586 | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 5: Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
| Cohort 5: AGN-151586 | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | 0 Participants |
Primary
Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention
Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.
Time frame: From first dose of study drug until the end of study (up to 42 days)
Population: Safety population included all participants who received study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Placebo | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 0 Participants |
| Cohort 1: AGN-151586 | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 7 Participants |
| Cohort 2: Placebo | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 1 Participants |
| Cohort 2: AGN-151586 | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 5 Participants |
| Cohort 3: Placebo | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 3 Participants |
| Cohort 3: AGN-151586 | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 4 Participants |
| Cohort 4: Placebo | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 0 Participants |
| Cohort 4: AGN-151586 | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 4 Participants |
| Cohort 5: Placebo | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 5 Participants |
| Cohort 5: AGN-151586 | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | 8 Participants |
Primary
Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention
Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.
Time frame: From first dose of study drug until the end of study (up to 42 days)
Population: Safety population included all participants who received study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 2 Participants |
| Cohort 1: AGN-151586 | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 0 Participants |
| Cohort 2: Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 0 Participants |
| Cohort 2: AGN-151586 | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 2 Participants |
| Cohort 3: Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 1 Participants |
| Cohort 3: AGN-151586 | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 0 Participants |
| Cohort 4: AGN-151586 | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 1 Participants |
| Cohort 5: Placebo | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 0 Participants |
| Cohort 5: AGN-151586 | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | 1 Participants |
Primary
Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7
Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline (Day 1) through Day 7
Population: mITT population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated FWS measurement at maximum frown.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Placebo | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 0.0 percentage of participants |
| Cohort 1: AGN-151586 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 40.6 percentage of participants |
| Cohort 2: Placebo | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 0.0 percentage of participants |
| Cohort 2: AGN-151586 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 46.4 percentage of participants |
| Cohort 3: Placebo | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 18.2 percentage of participants |
| Cohort 3: AGN-151586 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 70.4 percentage of participants |
| Cohort 4: Placebo | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 20.0 percentage of participants |
| Cohort 4: AGN-151586 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 83.3 percentage of participants |
| Cohort 5: Placebo | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 11.1 percentage of participants |
| Cohort 5: AGN-151586 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | 96.8 percentage of participants |
p-value: 0.009695% CI: [23.6, 57.6]Cochran-Mantel-Haenszel
p-value: 0.009495% CI: [28, 64.9]Cochran-Mantel-Haenszel
p-value: 0.004495% CI: [23.6, 80.8]Cochran-Mantel-Haenszel
p-value: 0.002695% CI: [35.2, 91.5]Cochran-Mantel-Haenszel
p-value: 095% CI: [64.2, 100]Cochran-Mantel-Haenszel