Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TrenibotulinumtoxinE and OnabotulinumtoxinA · 1 trial · 2 indications
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.
Achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity.
| Arm | Type | Description |
|---|---|---|
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 1 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 2 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 3 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 4 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 5 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 6 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 7 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| TrenibotulinumtoxinE/OnabotulinumtoxinA Combination 8 | EXPERIMENTAL | Participants will receive a single treatment of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA. |
| OnabotulinumtoxinA | ACTIVE_COMPARATOR | Participants will receive a single treatment of onabotulinumtoxinA. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single treatment of placebo. |
| Name | Type | Description |
|---|---|---|
| TrenibotulinumtoxinE and OnabotulinumtoxinA | DRUG | Injection |
| Placebo | DRUG | Injection |
| OnabotulinumtoxinA | DRUG | Injection |
Inclusion Criteria: * For glabellar lines (GL) indication: participant must have moderate or severe GL at maximum furrow as assessed by both the investigator and participant using the AGLSS at Screening and Baseline (Day 1) visits. * Participant must be in good health as per investigator's judgment...