Psoriasis Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

47

Study ID:

NCT05511519

Recruitment Status:

Terminated

Sponsor:

Aclaris Therapeutics, Inc.

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There are 22 Locations for this study

See Locations Near You

Aclaris Investigational Site
Miami Lakes Florida, 33014, United States
Aclaris Investigational Site
Tampa Florida, 33613, United States
Aclaris Clinical Operations
Freehold New Jersey, 07728, United States
Aclaris Clinical Operations
Charlotte North Carolina, 28210, United States
Aclaris Investigational Site
Perrysburg Ohio, 43551, United States
Aclaris Investigational Site
Duncansville Pennsylvania, 16635, United States
Aclaris Investigational Site
Memphis Tennessee, 38119, United States
Aclaris Investigational Site
Mesquite Texas, 75150, United States
Aclaris Investigational Site
Białystok , 15-70, Poland
Aclaris Investigational Site
Bydgoszcz , 85-16, Poland
Aclaris Investigational Site
Częstochowa , 42-20, Poland
Aclaris Investigational Site
Katowice , 40-04, Poland
Aclaris Investigational Site
Katowice , 40-08, Poland
Aclaris Investigational Site
Kraków , 30-36, Poland
Aclaris Investigational Site
Kraków , 30-51, Poland
Aclaris Investigational Site
Olsztyn , 10-34, Poland
Aclaris Investigational Site
Poznań , 60-70, Poland
Aclaris Investigational Site
Stalowa Wola , 37-45, Poland
Aclaris Investigational Site
Szczecin , 70-33, Poland
Aclaris Investigational Site
Toruń , 87-10, Poland
Aclaris Investigational Site
Warszawa , 04-14, Poland
Aclaris Investigational Site
Wrocław , 50-38, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

47

Study ID:

NCT05511519

Recruitment Status:

Terminated

Sponsor:


Aclaris Therapeutics, Inc.

How clear is this clinincal trial information?

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