ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA

Rheumatoid Arthritis Clinical Trial

Official title:

ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05279417
• Other study ID #: ATI-450-RA-202
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Rheumatoid Arthritis

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