Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING)
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING)
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 1:1:1 ratio to receive either low dose of tezepelumab, high dose of tezepelumab, or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
Actual Study Start Date: November 10, 2022
Estimated Primary Completion Date: May 1, 2026
Estimated Study Completion Date: January 8, 2027
Arm:
- Experimental: Tezepelumab Low Dose
- Experimental: Tezepelumab High Dose
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 360 |
| Actual Study start date | 10 November 2022 |
| Estimated Study Completion Date | 08 January 2027 |