Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dual therapy with navepegritide and lonapegsomatropin · 1 trial · 1 indication
To evaluate the AGV, cm per year, of dual therapy with navepegritide and lonapegsomatropin compared to navepegritide alone
| Arm | Type | Description |
|---|---|---|
| Once weekly navepegritide SC and lonapegsomatropin SC | EXPERIMENTAL | - |
| Once weekly navepegritide SC and placebo for lonapegsomatropin SC | EXPERIMENTAL | - |
| Once weekly lonapegsomatropin SC and placebo for navepegritide SC | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dual therapy with navepegritide and lonapegsomatropin | DRUG | Administered weekly as two separate SC injections. Treatment duration of up to 104 weeks |
| Dual therapy with navepegritide and placebo for lonapegsomatropin | DRUG | Administered as two separate SC injections. Treatment duration of up to 52 weeks of navepegritide and placebo for lonapegsomatropin followed by 52 weeks of navepegritide and lonapegsomatropin. |
| Dual therapy with lonapegsomatropin and placebo for navepegritide | DRUG | Administered as two separate SC injections. Treatment duration of up to 52 weeks of lonapegsomatropin and placebo for navepegritide followed by 52 weeks of navepegritide and lonapegsomatropin. |
Inclusion Criteria: * 1\. Age 2 to \<18 years at randomization * 2\. Clinical diagnosis of ACH with historical genetic confirmation * 3\. At least 1 height measurement available from medical records Exclusion Criteria: * 1\. Treatment with growth hormone within 1 year prior to randomization * 2\....