Patients with Moderate to Severe Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Zunsemetinib
Product Code: ATI-450
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1640282-42-3
Current Sponsor code: ATI-450
Other descriptive name: (P)-3-chloro-4-((3,5
Sponsors
Aclaris Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of multiple doses of ATI-450 plus MTX versus placebo plus MTX in Patients with moderate to severe active RA;Secondary Objective: 1. To assess the efficacy and safety of ATI-450 plus MTX in patients with moderate to severe active RA. 2. To assess the PK of ATI-450 in patients with moderate to severe active RA who are receiving concomitant MTX. 3. To conduct dose response modeling of ATI-450 in patients with moderate to severe RA who are receiving concomitant MTX. 4. Exploratory: To assess the PD of ATI-450 plus MTX in patients with moderate to severe active RA;Primary end point(s): Proportion of patients achieving ACR20 ;Timepoint(s) of evaluation of this end point: At Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients achieving ACR50/70 at Week 12 • Proportion of patients achieving ACR20/50/70 at each scheduled timepoint • Mean change from baseline in DAS28-CRP over time • Proportion of patients achieving DAS28-CRP remission (score < 2.6) at each scheduled timepoint • Proportion of patients achieving DAS28-CRP low disease activity (score = 3.2) at each scheduled timepoint • Mean change from baseline in CDAI over time • Proportion of patients achieving CDAI remission (score = 2.8) at each scheduled timepoint • Percent change from baseline in hsCRP level each scheduled timepoint • HAQ-DI score over time • SF-36v2 score over time • FACIT-Fatigue score over time • AEs, SAEs, vital signs, laboratory values, PEs, and ECGs • Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits. On Day 1, 8, and 85, trough and 2-hour post dose will be collected. • Proportion of patients achieving ACR20/50/70 at Week 12 • Change from baseline to Week 12 in DAS28-CRP;Timepoint(s) of evaluation of this end point: At Week 12 | — |
Countries
Bulgaria, Czechia, Czech Republic, Poland, United States
Contacts
Public ContactAjay Aggarwal
Aclaris Therapeutics, Inc.
Outcome results
None listed