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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07588568 | A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis | PHASE2 | NOT YET_RECRUITING | 52 | — | — | Jul 1, 2026 | Jun 1, 2030 | May 15, 2026 | 2 | United States |
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...