A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis (KRYPTOS)
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis (KRYPTOS)
This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis
Actual Study Start Date: July 6, 2020
Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: May 2022
Arm:
- Placebo Comparator: Placebo
- Experimental: 1 mg/kg of lirentelimab (AK002)
- Experimental: 3 mg/kg of lirentelimab (AK002)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 277 |
| Actual Study start date | 06 July 2020 |
| Estimated Study Completion Date | 01 May 2022 |