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

Primary Purpose

Rheumatoid Arthritis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATI-450 50mg oral tablet BID
Placebo oral tablet
Methotrexate
ATI-450 20mg oral tablet BID
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid, Arthritis, RA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
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  • Aclaris Investigational Site
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  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ATI-450 20mg BID plus Methotrexate

ATI-450 50mg BID plus Methotrexate

Placebo plus Methotrexate

Arm Description

ATI-450 20mg oral tablet BID with a stable weekly dose of Methotrexate

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

Placebo oral tablet BID with a stable weekly dose of Methotrexate

Outcomes

Primary Outcome Measures

Proportion of patients achieving ACR20 at Week 12

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2022
Last Updated
August 30, 2023
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05279417
Brief Title
ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid, Arthritis, RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATI-450 20mg BID plus Methotrexate
Arm Type
Experimental
Arm Description
ATI-450 20mg oral tablet BID with a stable weekly dose of Methotrexate
Arm Title
ATI-450 50mg BID plus Methotrexate
Arm Type
Experimental
Arm Description
ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate
Arm Title
Placebo plus Methotrexate
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet BID with a stable weekly dose of Methotrexate
Intervention Type
Drug
Intervention Name(s)
ATI-450 50mg oral tablet BID
Other Intervention Name(s)
zunsemetinib
Intervention Description
Oral, small molecule MK2 inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo tablet manufactured to match ATI-450 in appearance
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
15 mg to 25 mg weekly
Intervention Type
Drug
Intervention Name(s)
ATI-450 20mg oral tablet BID
Other Intervention Name(s)
zunsemetinib
Intervention Description
Oral, small molecule MK2 inhibitor
Primary Outcome Measure Information:
Title
Proportion of patients achieving ACR20 at Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Proportion of patients achieving ACR50/70 at Week 12
Time Frame
Baseline to Week 12
Title
Proportion of patients achieving ACR20/50/70 over time
Time Frame
Up to 12 Weeks
Title
Mean change from baseline in DAS28-CRP over time
Time Frame
Up to 12 Weeks
Title
Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time
Time Frame
Up to 12 Weeks
Title
Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time
Time Frame
Up to 12 Weeks
Title
Mean change from baseline in CDAI over time
Time Frame
Up to 12 Weeks
Title
Proportion of patients achieving CDAI remission (score ≤ 2.8) over time
Time Frame
Up to 12 Weeks
Title
Percent change from baseline in hsCRP level over time
Time Frame
Up to 30 days after 12 weeks of treatment
Title
Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time
Time Frame
Up to 12 Weeks
Title
Short Form Health Survey version-2.0 (SF-36v2) score over time
Time Frame
Up to 12 Weeks
Title
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time
Time Frame
Up to 12 Weeks
Title
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
Time Frame
Baseline to Week 12
Title
Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected).
Time Frame
Study Days 1, 8, and 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Aggarwal
Organizational Affiliation
Aclaris Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Aclaris Investigational Site
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Aclaris Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Aclaris Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Aclaris Investigational Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Aclaris Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Aclaris Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Aclaris Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Aclaris Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Aclaris Investigational Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Aclaris Investigational Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Aclaris Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aclaris Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Aclaris Investigational Site
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Hlučín
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Praha
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Uherské Hradiště
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Aclaris Investigational Site
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Aclaris Investigational Site
City
Tomaszów Lubelski
State/Province
Lubelski
ZIP/Postal Code
22-600
Country
Poland
Facility Name
Aclaris Investigational Site
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Aclaris Investigational Site
City
Nadarzyn
State/Province
Mazowieckie
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Aclaris Investigational Site
City
Grodzisk Mazowiecki
State/Province
Mzowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Aclaris Investigational Site
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Aclaris Investigational Site
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Aclaris Investigational Site
City
Elbląg
State/Province
Warm.Maz.
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Aclaris Investigational Site
City
Olsztyn
State/Province
Warmińsko-Mazurskien
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Aclaris Investigational Site
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Aclaris Investigational Site
City
Białystok
ZIP/Postal Code
15-297
Country
Poland
Facility Name
Aclaris Investigational Site
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Aclaris Investigational Site
City
Dąbrówka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Aclaris Investigational Site
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Aclaris Investigational Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Aclaris Investigational Site
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Aclaris Investigational Site
City
Poznań
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Aclaris Investigational Site
City
Poznań
ZIP/Postal Code
60-446
Country
Poland
Facility Name
Aclaris Investigational Site
City
Poznań
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Aclaris Investigational Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Aclaris Investigational Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Aclaris Investigational Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Aclaris Investigational Site
City
Wrocław
ZIP/Postal Code
52-442
Country
Poland

12. IPD Sharing Statement

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

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