Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Upadacitinib, Upadacitinib (ABT-494), Upadacitinib 30mg Dose, Upadacitinib 15mg Dose
Upadacitinib Dose · 1 trial · 3 indications
Peak eosinophil count (number of eosinophils per high power field (eos/hpf)) will be measured at 12-weeks post-treatment via esophageal biopsy during the study endoscopy. Eosinophil counts will be determined centrally by the study pathologist using a validated protocol.
| Arm | Type | Description |
|---|---|---|
| Upadacitinib 30mg | EXPERIMENTAL | Participants randomly assigned to this arm will receive the active drug for the entire 24 week treatment period. During the first 12 weeks, participants will receive blinded upadacitinib 30mg daily (meaning the participant and study team will not know which medication the participant receives) followed by open-label upadacitinib 30mg daily for 12 weeks. |
| Placebo, followed by Upadacitinib 30mg | OTHER | Participants randomly assigned to this arm will receive placebo for 12 weeks, followed by upadacitinib 30mg for 12 weeks. During the first 12 weeks, participants will receive blinded placebo daily (meaning the participant and study team will not know which medication the participant receives) followed by open-label upadacitinib 30mg daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Upadacitinib 30mg Dose | DRUG | Upadacitinib 30mg oral tablet. Participants randomly assigned to receive upadacitinib will take upadacitinib 30mg daily throughout the study. Participants randomly assigned to receive placebo will receive upadacitinib for 12 weeks after completing the 12 week blinded treatment period. |
| Upadacitinib Matching Placebo | OTHER | Oral tablet matching in size, shape, color, and taste to the study intervention (upadacitinib). Participants randomly assigned to receive placebo will receive upadacitinib matching placebo for 12 weeks, followed by a 12 week open label treatment period where all participants will receive upadacitinib 30mg. |
Inclusion Criteria: 1. Age 18-65 years. 2. Diagnosis of EoE per 2018 AGREE consensus guidelines. 3. Currently using topical corticosteroids (TCS) for EoE treatment (either swallowed budesonide, ≥2mg total daily dose or swallowed fluticasone, ≥1760 mcg total daily dose) for at least 8 weeks (prior t...
Upadacitinib is an investigational small molecule being developed for rheumatoid arthritis, spondyloarthritis, Crohn's disease, JAK1 gain-of-function conditions, giant cell arteritis, and psoriatic arthritis. It is in Phase 3 clinical development and is not yet approved by the FDA.
Upadacitinib targets Janus kinase 1 (JAK1), a member of the -tinib kinase family. By inhibiting JAK1, it modulates signaling pathways involved in inflammation and immune responses, which are relevant to autoimmune and inflammatory conditions.
Upadacitinib is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting multiple clinical trials to evaluate the drug across various inflammatory and autoimmune indications.
Upadacitinib is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The development program includes multiple Phase 3 trials in rheumatoid arthritis and psoriatic arthritis, with some trials completed and others active but not recruiting.
Upadacitinib is being studied in several clinical trials, including NCT02629159, a Phase 3 trial in rheumatoid arthritis comparing it to placebo and adalimumab, and NCT03104400, a Phase 3 trial in psoriatic arthritis. Other trials include NCT02720523 and NCT03104374, covering rheumatoid arthritis and psoriatic arthritis.
Yes, Upadacitinib is also known as ABT-494. It is sometimes referred to by its dose, such as Upadacitinib 15mg or 30mg. These names refer to the same investigational drug being developed by AbbVie.