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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT05511519

Run by

Aclaris Therapeutics, Inc.

People needed

47

Starts

2022-07-12

Expected to finish

2024-01-03

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA.
• Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as
• ≥3 tender joints (based on 68 joint counts) and
• ≥3 swollen joints (based on 66 joint counts).
• Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

You may not qualify if…

• Any arthritis with onset before age 17 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
• Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, eg, cirrhosis, previous malignancy, previous venous thromboembolism.
• Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient's participation in the study, per judgment of the investigator.

Where it is running

• Aclaris Investigational Site — Miami Lakes, Florida, United States
• Aclaris Investigational Site — Tampa, Florida, United States
• Aclaris Clinical Operations — Freehold, New Jersey, United States
• Aclaris Clinical Operations — Charlotte, North Carolina, United States
• Aclaris Investigational Site — Perrysburg, Ohio, United States
• Aclaris Investigational Site — Duncansville, Pennsylvania, United States
• Aclaris Investigational Site — Memphis, Tennessee, United States
• Aclaris Investigational Site — Mesquite, Texas, United States
• Aclaris Investigational Site — Bialystok, Poland
• Aclaris Investigational Site — Bydgoszcz, Poland
• Aclaris Investigational Site — Częstochowa, Poland
• Aclaris Investigational Site — Katowice, Poland
• Aclaris Investigational Site — Katowice, Poland
• Aclaris Investigational Site — Krakow, Poland
• Aclaris Investigational Site — Krakow, Poland
• Aclaris Investigational Site — Olsztyn, Poland
• Aclaris Investigational Site — Poznan, Poland
• Aclaris Investigational Site — Stalowa Wola, Poland
• Aclaris Investigational Site — Szczecin, Poland
• Aclaris Investigational Site — Torun, Poland
• Aclaris Investigational Site — Warsaw, Poland
• Aclaris Investigational Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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