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...
Stelara is used for the treatment of moderate-to-severe chronic plaque psoriasis. It is being studied in a Phase 3 clinical trial for this condition. The drug is administered to adult patients aged 18 years and older. The trial enrolled 581 participants across multiple countries.
Stelara is being developed by Alvotech, a biopharmaceutical company. Alvotech is publicly traded under the ticker symbol ALVO. The company is conducting clinical trials to evaluate the efficacy, safety, and immunogenicity of Stelara in patients with moderate-to-severe chronic plaque psoriasis.
Stelara is in Phase 3 clinical development. The Phase 3 trial, identified as NCT04930042, has been completed. This trial was a randomized, double-blind, active-controlled study that enrolled 581 participants. Stelara is an investigational drug and has not yet been approved by regulatory authorities.
Stelara has one completed Phase 3 clinical trial with the identifier NCT04930042. The trial was titled 'Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis' and enrolled 581 participants. The study was conducted in Estonia, Georgia, Poland, and Ukraine.
Yes, Stelara is also known as AVT04. The Phase 3 clinical trial NCT04930042 evaluated the efficacy, safety, and immunogenicity of AVT04 in patients with moderate-to-severe chronic plaque psoriasis. This trial enrolled 581 participants and was completed.