Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rezpegaldesleukin · 4 trials · 3 indications
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
| Arm | Type | Description |
|---|---|---|
| Blinded Induction Period: Rezpegaldesleukin every 2 weeks | EXPERIMENTAL | Rezpegaldesleukin every 2 weeks during the induction period |
| Blinded Induction Period: Placebo | PLACEBO_COMPARATOR | Placebo every 2 weeks during the induction period |
| Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks | EXPERIMENTAL | Rezpegaldesleukin every 4 weeks during the maintenance period |
| Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks | EXPERIMENTAL | Rezpegaldesleukin every 12 weeks during the maintenance period |
| Blinded Maintenance Period: Placebo | PLACEBO_COMPARATOR | Placebo every 4 weeks during the maintenance period |
| Open-Label Escape | EXPERIMENTAL | Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape |
| Low Dose | EXPERIMENTAL | Rezpegaldesleukin Low Dose Every 2 weeks |
| High Dose | EXPERIMENTAL | Rezpegaldesleukin High Dose Every 2 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo Every 2 weeks |
| Arm A | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period |
| Arm A1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period |
| Arm A2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period |
| Arm B | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period |
| Arm B1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period |
| Arm B2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period |
| Arm C | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period |
| Arm C1 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period |
| Arm C2 | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period |
| Arm D | PLACEBO_COMPARATOR | Placebo every 2 weeks during the induction period |
| Arm D1 | PLACEBO_COMPARATOR | Placebo every 4 weeks during the maintenance period |
| Escape Therapy (open-label) | EXPERIMENTAL | Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period |
| Name | Type | Description |
|---|---|---|
| Rezpegaldesleukin | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Injection solution Route of administration: subcutaneous |
Inclusion Criteria: * Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline * Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms ≥ 12 months prior to Screening as determined by the ...