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

Phase 2TerminatedNCT05511519

Aclaris Therapeutics, Inc.47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Psoriatic Arthritis

Interventions

ATI-450DRUG

Oral, small molecule MK2 inhibitor

Placebo Oral TabletDRUG

Placebo tablet manufactured to match ATI-450 in appearance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (22)

Aclaris Investigational Site

Miami Lakes, Florida, United States

Aclaris Investigational Site

Outcomes

Primary Outcomes

Proportion of patients achieving ACR20 at Week 12

Time frame: Baseline to Week 12

Secondary Outcomes

Proportion of patients with ACR 50/70 at Week 12

Time frame: Baseline to Week 12

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

Time frame: Baseline to Week 12

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

Time frame: Baseline to Week 12

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

Time frame: Baseline to Week 12

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

Time frame: Baseline to Week 12

Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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Tampa, Florida, United States

Aclaris Clinical Operations

Freehold, New Jersey, United States

Aclaris Clinical Operations

Charlotte, North Carolina, United States

Aclaris Investigational Site

Perrysburg, Ohio, United States

Aclaris Investigational Site

Duncansville, Pennsylvania, United States

Aclaris Investigational Site

Memphis, Tennessee, United States

Aclaris Investigational Site

Mesquite, Texas, United States

Aclaris Investigational Site

Bialystok, Poland

Aclaris Investigational Site

Bydgoszcz, Poland

...and 12 more locations

Change from baseline in Leeds Enthesitis Index over 12 weeks

Time frame: Baseline to Week 12

Change from baseline in Leeds Dactylitis Index over 12 weeks

Time frame: Baseline to Week 12

Proportion of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Daily Assessment of Skin Pain at Weeks 2, 4, 8, 12 among patients with Baseline NRS ≥3

Time frame: Baseline to Week 12

Proportion of patients achieving a sIGA of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline among those with a baseline investigator's global assessment of at least 3 over 12 weeks

Time frame: Baseline to Week 12

Proportion of patients achieving MDA at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12

Time frame: Baseline to Week 12

Mean change from baseline in PASI score at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12

Time frame: Baseline to Week 12

Type and frequency of adverse events

Time frame: Baseline to Week 12

Type and frequency of serious adverse events

Time frame: Baseline to Week 12

Zunsemetinib trough concentration ng/mL

Time frame: Baseline to Week 12

CDD-2164 metabolite trough concentration ng/mL

Time frame: Baseline to Week 12

Zunsemetinib peak concentration (Cmax) ng/mL

Time frame: Baseline to Week 12

CDD-2164 metabolite peak concentration (Cmax) ng/mL

Time frame: Baseline to Week 12