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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05279417
Other study ID # ATI-450-RA-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 2022
Est. completion date October 11, 2023

Study information

Verified date November 2023
Source Aclaris Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone


Description:

This is a Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone


Recruitment information / eligibility

Status Completed
Enrollment 251
Est. completion date October 11, 2023
Est. primary completion date September 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient ICF prior to administration of any study-related procedures. - Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria. - Have active moderate to severe RA at Screening. - A minimum of 12 weeks on MTX with a stable MTX dose. Exclusion Criteria: - Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA. - Uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism). - Patient has experience with > 2 biologics, > 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor. - Currently receiving corticosteroids at doses > 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ATI-450 50mg oral tablet BID
Oral, small molecule MK2 inhibitor
Placebo oral tablet
Placebo tablet manufactured to match ATI-450 in appearance
Methotrexate
15 mg to 25 mg weekly
ATI-450 20mg oral tablet BID
Oral, small molecule MK2 inhibitor

Locations

Country Name City State
Bulgaria Aclaris Investigational Site Pleven
Bulgaria Aclaris Investigational Site Plovdiv
Bulgaria Aclaris Investigational Site Plovdiv
Bulgaria Aclaris Investigational Site Plovdiv
Bulgaria Aclaris Investigational Site Plovdiv
Bulgaria Aclaris Investigational Site Sofia
Bulgaria Aclaris Investigational Site Sofia
Bulgaria Aclaris Investigational Site Sofia
Bulgaria Aclaris Investigational Site Varna
Czechia Aclaris Investigational Site Brno
Czechia Aclaris Investigational Site Hlucín
Czechia Aclaris Investigational Site Ostrava
Czechia Aclaris Investigational Site Pardubice
Czechia Aclaris Investigational Site Praha
Czechia Aclaris Investigational Site Praha
Czechia Aclaris Investigational Site Uherské Hradište
Poland Aclaris Investigational Site Bialystok Podlaskie
Poland Aclaris Investigational Site Bialystok
Poland Aclaris Investigational Site Bialystok
Poland Aclaris Investigational Site Dabrówka
Poland Aclaris Investigational Site Elblag Warm.Maz.
Poland Aclaris Investigational Site Grodzisk Mazowiecki Mzowieckie
Poland Aclaris Investigational Site Katowice Silesia
Poland Aclaris Investigational Site Kraków Malopolskie
Poland Aclaris Investigational Site Kraków
Poland Aclaris Investigational Site Lublin
Poland Aclaris Investigational Site Lublin Lubelskie
Poland Aclaris Investigational Site Nadarzyn Mazowieckie
Poland Aclaris Investigational Site Nowa Sól
Poland Aclaris Investigational Site Olsztyn Warminsko-Mazurskien
Poland Aclaris Investigational Site Poznan Wielkopolska
Poland Aclaris Investigational Site Poznan
Poland Aclaris Investigational Site Poznan
Poland Aclaris Investigational Site Poznan
Poland Aclaris Investigational Site Sochaczew
Poland Aclaris Investigational Site Tomaszów Lubelski Lubelski
Poland Aclaris Investigational Site Torun
Poland Aclaris Investigational Site Warszawa
Poland Aclaris Investigational Site Wroclaw
United States Aclaris Investigational Site Cypress Texas
United States Aclaris Investigational Site Duncansville Pennsylvania
United States Aclaris Investigational Site El Cajon California
United States Aclaris Investigational Site Encino California
United States Aclaris Investigational Site Jackson Tennessee
United States Aclaris Investigational Site La Jolla California
United States Aclaris Investigational Site Mesquite Texas
United States Aclaris Investigational Site Oklahoma City Oklahoma
United States Aclaris Investigational Site Palm Desert California
United States Aclaris Investigational Site San Antonio Texas
United States Aclaris Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Aclaris Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  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 achieving ACR50/70 at Week 12 Baseline to Week 12
Secondary Proportion of patients achieving ACR20/50/70 over time Up to 12 Weeks
Secondary Mean change from baseline in DAS28-CRP over time Up to 12 Weeks
Secondary Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time Up to 12 Weeks
Secondary Proportion of patients achieving DAS28-CRP low disease activity (score = 3.2) over time Up to 12 Weeks
Secondary Mean change from baseline in CDAI over time Up to 12 Weeks
Secondary Proportion of patients achieving CDAI remission (score = 2.8) over time Up to 12 Weeks
Secondary Percent change from baseline in hsCRP level over time Up to 30 days after 12 weeks of treatment
Secondary Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time Up to 12 Weeks
Secondary Short Form Health Survey version-2.0 (SF-36v2) score over time Up to 12 Weeks
Secondary Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time Up to 12 Weeks
Secondary Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities Baseline to Week 12
Secondary Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected). Study Days 1, 8, and 85
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