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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05511519
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aclaris Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Poland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: ATI-450

ATI-450 50mg oral tablet BID

Placebo Comparator: Placebo

Placebo oral tablet BID

Interventions

Drug: - ATI-450

Oral, small molecule MK2 inhibitor

Drug: - Placebo Oral Tablet

Placebo tablet manufactured to match ATI-450 in appearance

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aclaris Investigational Site, Miami Lakes, Florida

Status

Not yet recruiting

Address

Aclaris Investigational Site

Miami Lakes, Florida, 33014

Site Contact

Aclaris Clinical Operations

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