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

Sponsored by Aclaris Therapeutics, Inc.

About this trial

Last updated 2 years ago

Study ID

ATI-450-PsA-201

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
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Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
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Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting