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

NCT05511519 | Terminated Phase 2 FDA Drug

• 1 other identifier: ATI-450-PsA-201
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 22

Brief 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.

Conditions

Psoriatic Arthritis

Keywords

Arthritis; Psoriatic

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ACR20 at Week 12

  Baseline to Week 12

Secondary Outcomes (26)

• Proportion of patients with ACR 50/70 at Week 12

  Baseline to Week 12

• Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8

  Baseline to Week 12

• Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12

  Baseline to Week 12

• Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12

  Baseline to Week 12

• Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12

  Baseline to Week 12

Study Arms (2)

ATI-450

EXPERIMENTAL

ATI-450 50mg oral tablet BID

Drug: ATI-450

Placebo

PLACEBO COMPARATOR

Placebo oral tablet BID

Drug: Placebo Oral Tablet

Interventions

ATI-450 DRUG

Oral, small molecule MK2 inhibitor

Also known as: CDD-450

ATI-450

Placebo Oral Tablet DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (22)

Aclaris Investigational Site

Miami Lakes, Florida, 33014, United States

Location

Aclaris Investigational Site

Tampa, Florida, 33613, United States

Location

Aclaris Clinical Operations

Freehold, New Jersey, 07728, United States

Location

Aclaris Clinical Operations

Charlotte, North Carolina, 28210, United States

Location

Aclaris Investigational Site

Perrysburg, Ohio, 43551, United States

Location

Aclaris Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Aclaris Investigational Site

Memphis, Tennessee, 38119, United States

Location

Aclaris Investigational Site

Mesquite, Texas, 75150, United States

Location

Aclaris Investigational Site

Bialystok, 15-707, Poland

Location

Aclaris Investigational Site

Bydgoszcz, 85-168, Poland

Location

Aclaris Investigational Site

Częstochowa, 42-200, Poland

Location

Aclaris Investigational Site

Katowice, 40-040, Poland

Location

Aclaris Investigational Site

Katowice, 40-081, Poland

Location

Aclaris Investigational Site

Krakow, 30-363, Poland

Location

Aclaris Investigational Site

Krakow, 30-510, Poland

Location

Aclaris Investigational Site

Olsztyn, 10-341, Poland

Location

Aclaris Investigational Site

Poznan, 60-702, Poland

Location

Aclaris Investigational Site

Stalowa Wola, 37-450, Poland

Location

Aclaris Investigational Site

Szczecin, 70-332, Poland

Location

Aclaris Investigational Site

Torun, 87-100, Poland

Location

Aclaris Investigational Site

Warsaw, 04-141, Poland

Location

Aclaris Investigational Site

Wroclaw, 50-381, Poland

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 23, 2022
• Study Start: July 12, 2022
• Primary Completion: December 6, 2023
• Study Completion: January 3, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

PL (14); US (8)