Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05637515 | Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity | PHASE3 | COMPLETED | 374 | — | — | Nov 21, 2022 | Sep 19, 2023 | Oct 22, 2024 | 36 | Bulgaria, Czechia +2 |
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...