Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stelara · 1 trial · 1 indication
Percent (%) change in Psoriasis Area and Severity Index (PASI)
| Arm | Type | Description |
|---|---|---|
| AVT04 45 mg SC | EXPERIMENTAL | Test Product: AVT04 (ustekinumab) Initial loading dose of 45 mg followed by 45 mg SC once every 12 weeks starting 4 weeks after the initial loading dose administered SC. Injected as subcutaneous in thigh and abdomen. |
| EU Stelara 45 mg SC | ACTIVE_COMPARATOR | Comparator ref product: EU Stelara (ustekinumab) Initial loading dose of 45 mg followed by 45 mg SC once every 12 weeks starting 4 weeks after the initial loading dose administered SC. Injected as subcutaneous in thigh and abdomen. |
| Name | Type | Description |
|---|---|---|
| Stelara | DRUG | AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12 |
| AVT04 | DRUG | AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12 |
Inclusion Criteria: 1. Patient has signed the informed consent form (ICF) and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements. 2. Chinese patients shall be recruited in Mainland China. 3. Patient is male o...