Trials / Active Not Recruiting
Active Not RecruitingNCT05583227
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).
Detailed description
The study consists of a screening period of 2 to 8 weeks and a 52-week randomized double-blind placebo-controlled treatment period. After completion of the treatment period, participants will be eligible to participate in an optional active treatment extension period (lasting for 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period. This study will randomize approximately 360 participants. The participants will be randomized at 1:1:1 ratio to the 3 treatment arms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tezepelumab | Tezepelumab subcutaneous injection |
| BIOLOGICAL | Tezepelumab | Tezepelumab subcutaneous injection |
| OTHER | Placebo | Placebo subcutaneous injection |
Timeline
- Start date
- 2022-11-10
- Primary completion
- 2026-07-14
- Completion
- 2027-03-23
- First posted
- 2022-10-17
- Last updated
- 2026-01-16
Locations
125 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Slovakia, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05583227. Inclusion in this directory is not an endorsement.