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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05511519
Other study ID # ATI-450-PsA-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 12, 2022
Est. completion date January 3, 2024

Study information

Verified date April 2024
Source Aclaris Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 47
Est. completion date January 3, 2024
Est. primary completion date December 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ATI-450
Oral, small molecule MK2 inhibitor
Placebo Oral Tablet
Placebo tablet manufactured to match ATI-450 in appearance

Locations

Country Name City State
Poland Aclaris Investigational Site Bialystok
Poland Aclaris Investigational Site Bydgoszcz
Poland Aclaris Investigational Site Czestochowa
Poland Aclaris Investigational Site Katowice
Poland Aclaris Investigational Site Katowice
Poland Aclaris Investigational Site Kraków
Poland Aclaris Investigational Site Kraków
Poland Aclaris Investigational Site Olsztyn
Poland Aclaris Investigational Site Poznan
Poland Aclaris Investigational Site Stalowa Wola
Poland Aclaris Investigational Site Szczecin
Poland Aclaris Investigational Site Torun
Poland Aclaris Investigational Site Warszawa
Poland Aclaris Investigational Site Wroclaw
United States Aclaris Clinical Operations Charlotte North Carolina
United States Aclaris Investigational Site Duncansville Pennsylvania
United States Aclaris Clinical Operations Freehold New Jersey
United States Aclaris Investigational Site Memphis Tennessee
United States Aclaris Investigational Site Mesquite Texas
United States Aclaris Investigational Site Miami Lakes Florida
United States Aclaris Investigational Site Perrysburg Ohio
United States Aclaris Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Aclaris Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients achieving ACR20 at Week 12 Baseline to Week 12
Secondary Proportion of patients with ACR 50/70 at Week 12 Baseline to Week 12
Secondary Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8 Baseline to Week 12
Secondary Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12 Baseline to Week 12
Secondary Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Leeds Enthesitis Index over 12 weeks Baseline to Week 12
Secondary Change from baseline in Leeds Dactylitis Index over 12 weeks Baseline to Week 12
Secondary 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 Baseline to Week 12
Secondary 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 Baseline to Week 12
Secondary Proportion of patients achieving MDA at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with =3% body surface area psoriasis at baseline) at Week 12 Baseline to Week 12
Secondary Mean change from baseline in PASI score at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12 Baseline to Week 12
Secondary Type and frequency of adverse events Baseline to Week 12
Secondary Type and frequency of serious adverse events Baseline to Week 12
Secondary Zunsemetinib trough concentration ng/mL Baseline to Week 12
Secondary CDD-2164 metabolite trough concentration ng/mL Baseline to Week 12
Secondary Zunsemetinib peak concentration (Cmax) ng/mL Baseline to Week 12
Secondary CDD-2164 metabolite peak concentration (Cmax) ng/mL Baseline to Week 12
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