| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06308198 | A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines | PHASE3 | COMPLETED | 161 | — | — | Mar 29, 2024 | Feb 26, 2025 | Mar 19, 2025 | 12 | China, Japan +1 |
| NCT05248867 | A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines | PHASE3 | COMPLETED | 638 | — | — | Mar 16, 2022 | Mar 17, 2023 | May 24, 2024 | 38 | United States, Canada +3 |
| NCT05248880 | A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines | PHASE3 | COMPLETED | 309 | — | — | Mar 8, 2022 | Feb 1, 2023 | Feb 18, 2026 | 17 | United States, Canada |
| NCT05248893 | A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines | PHASE3 | COMPLETED | 986 | — | — | Feb 25, 2022 | Jun 26, 2023 | May 29, 2024 | 43 | United States, Puerto Rico |
| NCT04096326 | AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines | PHASE2 | COMPLETED | 198 | — | — | Sep 26, 2019 | Sep 9, 2020 | Jul 28, 2023 | 9 | United States |
| NCT06834789 | A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL) | PHASE1 | COMPLETED | 132 | — | — | Feb 18, 2025 | Nov 3, 2025 | Nov 17, 2025 | 8 | United States |
| NCT05496335 | A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines | PHASE1 | COMPLETED | 90 | — | — | Aug 30, 2022 | May 30, 2023 | Jun 8, 2023 | 10 | United States |
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
\[Primary endpoint for the United States FDA\] 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.
\[Primary endpoint for European Union regulatory agencies\] 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.
\[Primary endpoint for European Union regulatory agencies\] 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.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.
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.
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.
Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.
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.
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 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.
Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Period: AGN-151586 | EXPERIMENTAL | Participants will receive AGN-151586 in the glabellar complex on Day 1. |
| Double-Blind Period: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo in the glabellar complex on Day 1. |
| Open-Label: AGN-151586 | EXPERIMENTAL | Participants who meet all retreatment criteria will receive AGN-151586 in the glabellar complex on Day 43. |
| Placebo | PLACEBO_COMPARATOR | 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 | EXPERIMENTAL | 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. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
| Cohort 1: AGN-151586 | EXPERIMENTAL | Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. |
| Cohort 2: AGN-151586 | EXPERIMENTAL | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. |
| Cohort 3: AGN-151586 | EXPERIMENTAL | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. |
| Cohort 4: AGN-151586 | EXPERIMENTAL | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| Cohort 5: Placebo | PLACEBO_COMPARATOR | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. |
| Cohort 5: AGN-151586 | EXPERIMENTAL | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. |
| Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
| Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
| Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
| Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
| Cohort 3: Placebo and OnabotulinumtoxinA | EXPERIMENTAL | Participants will receive a single treatment of Placebo and OnabotulinumtoxinA. |
| AGN-151586, BOTOX | EXPERIMENTAL | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months. |
| Placebo, BOTOX | EXPERIMENTAL | Participants will receive 5 intramuscular injections of placebo in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months. |
| Name | Type | Description |
|---|---|---|
| AGN-151586 | DRUG | Intramuscular Injections |
| Placebo | DRUG | Intramuscular Injections |
| OnabotulinumtoxinA | DRUG | Intramuscular injection |
| BOTOX | DRUG | Intramuscular Injection |
Inclusion Criteria: * Must have Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the FWS-A at Screening and Baseline Day 1 visit. The investigator and participant ratings must match within a visit but do not have to match between Sc...