Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

NCT04247815 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATI-450-RA-201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.

Conditions

Rheumatoid Arthritis

Keywords

Arthritis; Rheumatoid

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs)

  Safety and tolerability reported as Adverse Events (AEs). AEs will be coded with the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. AEs will be presented by system organ class and preferred term in frequency tables.

  Baseline through Day 114

Secondary Outcomes (9)

• Percent Change in (hsCRP) Levels Over Time

  Baseline through Day 114

• Change From Baseline in Disease Activity Score

  Baseline through Day 114

• Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time

  Baseline through Day 114

• Change From Baseline in RAMRIS Hand-Wrist Assessments (Osteitis Average)

  Baseline through Day 84

• Change From Baseline in RAMRIS Hand-Wrist Assessments (Synovitis Average)

  Baseline through Day 84

Study Arms (2)

ATI-450 plus Methotrexate

EXPERIMENTAL

ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate

Drug: ATI-450; Drug: Methotrexate

Placebo plus Methotrexate

PLACEBO COMPARATOR

Placebo oral tablet BID with a stable weekly dose of Methotrexate

Drug: Placebo oral tablet; Drug: Methotrexate

Interventions

ATI-450 DRUG

Oral, small molecule MK2 inhibitor

Also known as: CDD-450

ATI-450 plus Methotrexate

Placebo oral tablet DRUG

Placebo tablet manufactured to match ATI-450 in appearance

Placebo plus Methotrexate

Methotrexate DRUG

7.5 mg to 25 mg weekly

ATI-450 plus Methotrexate; Placebo plus Methotrexate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
• DAS28-CRP ≥3.2 defined as moderate to high disease activity.
• Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
• hsCRP ≥5 mg/L at screening.
• Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
• On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.

You may not qualify if:

• Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
• Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
• History or evidence of active or latent tuberculosis.
• Active infection requiring treatment with antibiotics.
• Blood pressure levels (in supine position after at least 5 minutes rest): \<90 mmHg or \>140 mmHg for systolic blood pressure or \<40 mmHg or \>90 mmHg for diastolic blood pressure.
• Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
• Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
• Patients with history of stroke.
• Any joint procedure in the past 90 days prior to screening.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (5)

Aclaris Investigational Site

Anniston, Alabama, 36207, United States

Location

Aclaris Investigational Site

Tampa, Florida, 33613, United States

Location

Aclaris Investigational Site

Atlanta, Georgia, 30342, United States

Location

Aclaris Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Aclaris Investigational Site

Mesquite, Texas, 75150, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ajay Aggarwal
• Organization: Aclaris Therapeutics, Inc.

Clintrials@aclaristx.com

484-540-6296

Study Officials

• David Gordon

  Aclaris Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Model Details: Randomized, investigator and patient-blind, sponsor-unblinded, parallel group.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 30, 2020
• Study Start: March 16, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Locations

US (5)