NCT04524858

Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)

A Phase 2a, Open-Label, Single-Arm Study to Investigate the Safety and Efficacy of ATI-450 for the Maintenance of Remission in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed With Anti-IL-1 Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy.

Detailed description

This is a Phase 2a, Open-Label, Single-Arm Study to Investigate the Safety and Efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy. The study will consist of up to an 8-week screening period, a 12-week treatment period, and a 4-week safety follow-up period. The total duration of the study for patients remaining until their final follow-up assessment will be up to 24 weeks.

Conditions

• Cryopyrin-Associated Periodic Syndrome

Interventions

Type	Name	Description
DRUG	ATI-450	Oral, small molecule MK2 inhibitor

Timeline

• Start date: 2020-10-23
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2020-08-24
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study