Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stelara PFS · 1 trial · 1 indication
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT04, US Stelara EU Stelara
Venous blood samples will be collected for measurement of serum concentration of AVT04, EU Stelara, US Stelara
| Arm | Type | Description |
|---|---|---|
| AVT04 45 mg SC | EXPERIMENTAL | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| US Stelara 45 mg SC | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| EU Stelara 45 mg SC | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| Name | Type | Description |
|---|---|---|
| Stelara PFS | DRUG | Pre filled syringes filled with AVT04 and Stelara |
Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration: 1. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the ...
Stelara PFS is an investigational small molecule being developed for the treatment of psoriasis. It is currently in Phase 1 clinical development. The drug is being studied to evaluate its pharmacokinetics, safety, and tolerability in patients with psoriasis.
Stelara PFS 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 drug's safety and pharmacokinetics in patients with psoriasis.
Stelara PFS is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.
Stelara PFS has been studied in one completed Phase 1 clinical trial, identified as NCT04744363. This trial evaluated the pharmacokinetics, safety, and tolerability of AVT04 compared to EU approved and US licensed Stelara (ustekinumab) in 294 participants with psoriasis.
Stelara PFS is also known as AVT04. In clinical trials, the drug is referred to as AVT04, and it is being compared to Stelara (ustekinumab) to assess its pharmacokinetics, safety, and tolerability in patients with psoriasis.
Stelara PFS is a small molecule being developed for psoriasis. The specific molecular target has not been disclosed in the available information. Clinical trials are focused on evaluating its pharmacokinetics, safety, and tolerability compared to Stelara (ustekinumab).