MedDataX Logo

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

NCT ID: NCT05511519

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2024-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ATI-450

ATI-450 50mg oral tablet BID

Group Type EXPERIMENTAL

ATI-450

Intervention Type DRUG

Oral, small molecule MK2 inhibitor

Placebo

Placebo oral tablet BID

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ATI-450

Oral, small molecule MK2 inhibitor

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablet manufactured to match ATI-450 in appearance

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CDD-450

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aclaris Investigational Site

Miami Lakes, Florida, United States

Site Status

Aclaris Investigational Site

Tampa, Florida, United States

Site Status

Aclaris Clinical Operations

Freehold, New Jersey, United States

Site Status

Aclaris Clinical Operations

Charlotte, North Carolina, United States

Site Status

Aclaris Investigational Site

Perrysburg, Ohio, United States

Site Status

Aclaris Investigational Site

Duncansville, Pennsylvania, United States

Site Status

Aclaris Investigational Site

Memphis, Tennessee, United States

Site Status

Aclaris Investigational Site

Mesquite, Texas, United States

Site Status

Aclaris Investigational Site

Bialystok, , Poland

Site Status

Aclaris Investigational Site

Bydgoszcz, , Poland

Site Status

Aclaris Investigational Site

Częstochowa, , Poland

Site Status

Aclaris Investigational Site

Katowice, , Poland

Site Status

Aclaris Investigational Site

Katowice, , Poland

Site Status

Aclaris Investigational Site

Krakow, , Poland

Site Status

Aclaris Investigational Site

Krakow, , Poland

Site Status

Aclaris Investigational Site

Olsztyn, , Poland

Site Status

Aclaris Investigational Site

Poznan, , Poland

Site Status

Aclaris Investigational Site

Stalowa Wola, , Poland

Site Status

Aclaris Investigational Site

Szczecin, , Poland

Site Status

Aclaris Investigational Site

Torun, , Poland

Site Status

Aclaris Investigational Site

Warsaw, , Poland

Site Status

Aclaris Investigational Site

Wroclaw, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATI-450-PsA-201

Identifier Type: -

Identifier Source: org_study_id