NCT05511519

Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

Detailed description

This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	ATI-450	Oral, small molecule MK2 inhibitor
DRUG	Placebo Oral Tablet	Placebo tablet manufactured to match ATI-450 in appearance

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-12-06
• Completion: 2024-01-03
• First posted: 2022-08-23
• Last updated: 2024-11-27

Locations

22 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study