Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Humira in Prefilled Syringe · 1 trial · 2 indications
AUCτ, 26-28 (Area under the adalimumab concentration-time curve \[AUC\] over the dosing interval of Week 26-28)
Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).
| Arm | Type | Description |
|---|---|---|
| Humira continuously | ACTIVE_COMPARATOR | Subjects receive Humira continuously both during Run-in period and Randomized interchangeable treatment period. Run-in Period: Subjects will receive Humira (initial dose of 80 mg \[2 × 40 mg\]; Day 1 administered subcutaneously (SC), followed by 40 mg SC given every other week starting 1 week after the initial dose (last dose at Week 10). Randomized interchangeable treatment period: Subjects continue to receive Humira (40 mg every other week) until Week 26 |
| Repeated switches Humira - Hulio | EXPERIMENTAL | Subjects will receive Humira in Run-in period \& undergo repeated switches between Humira Hulio during randomized interchangeable treatment period Randomized interchangeable treatment period: * Subjects undergo repeated switches between Humira and Hulio between week 12 to week 26. * Hulio (40 mg every other week) at Week 12 and Week 14 * Humira (40 mg every other week) at Week 16 and Week 18, and * Hulio (40 mg every other week) at Week 20, Week 22, Week 24 and Week 26. |
| Name | Type | Description |
|---|---|---|
| Humira 40 MG in Prefilled Syringe | BIOLOGICAL | Humira (40 mg every other week) |
| Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe | BIOLOGICAL | • Subjects will receive Humira (initial dose of 80 mg \[2 × 40 mg\]; Day 1 administered subcutaneously (SC), followed by 40 mg SC given every other week starting 1 week after the initial dose (last dose at Week 10). Hulio (40 mg every other week) at Week 12 and Week 14 * Humira (40 mg every other week) at Week 16 and Week 18, and * Hulio (40 mg every other week) at Week 20, Week 22, Week 24 and Week 26. |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Able to understand and voluntarily provide written informed consent to participate in the study 2. Aged 18 to 75 years, inclusive, at the time of Screening 3. Has moderat...
Humira in Prefilled Syringe is a monoclonal antibody being studied for the treatment of moderate chronic plaque psoriasis. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial that includes patients with moderate and severe chronic plaque psoriasis.
Humira in Prefilled Syringe is a monoclonal antibody, a type of biologic therapy. As a monoclonal antibody, it is designed to bind to a specific target involved in the immune response. However, the specific molecular target for this drug has not been disclosed in the available information.
Humira in Prefilled Syringe is being developed by IQVIA Holdings, Inc., a company traded on the stock exchange under the ticker symbol IQV. IQVIA is the developer of this investigational drug, which is currently in Phase 3 clinical trials for moderate chronic plaque psoriasis.
Humira in Prefilled Syringe is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a Phase 3 trial that has been completed, with a total enrollment of 374 participants.
Humira in Prefilled Syringe is associated with one clinical trial, identified as NCT05637515. This Phase 3 study, titled 'Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity', has been completed. The trial enrolled 374 participants and was conducted in Bulgaria, Czechia, Estonia, and Poland.
Humira in Prefilled Syringe is being studied in a clinical trial that compares it to Humira, with the trial title referencing 'Hulio Interchangeability to Humira'. This suggests that Humira in Prefilled Syringe may be related to or compared with a product called Hulio, but the available information does not explicitly confirm that they are the same drug.