ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)

PHASE2CompletedINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

September 5, 2023

Study Completion Date

October 11, 2023

Conditions
Rheumatoid Arthritis
Interventions
DRUG

ATI-450 50 mg oral tablet BID

Oral, small molecule MK2 inhibitor

DRUG

Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

DRUG

Methotrexate

15 mg to 25 mg weekly

DRUG

ATI-450 20 mg oral tablet BID

Oral, small molecule MK2 inhibitor

Trial Locations (50)

1336

Aclaris Investigational Site, Sofia

1431

Aclaris Investigational Site, Sofia

1606

Aclaris Investigational Site, Sofia

4000

Aclaris Investigational Site, Plovdiv

4001

Aclaris Investigational Site, Plovdiv

4002

Aclaris Investigational Site, Plovdiv

4004

Aclaris Investigational Site, Plovdiv

5800

Aclaris Investigational Site, Pleven

9000

Aclaris Investigational Site, Varna

16635

Aclaris Investigational Site, Duncansville

33613

Aclaris Investigational Site, Tampa

38305

Aclaris Investigational Site, Jackson

73103

Aclaris Investigational Site, Oklahoma City

75150

Aclaris Investigational Site, Mesquite

77429

Aclaris Investigational Site, Cypress

78229

Aclaris Investigational Site, San Antonio

91436

Aclaris Investigational Site, Encino

92020

Aclaris Investigational Site, El Cajon

92093

Aclaris Investigational Site, La Jolla

92260

Aclaris Investigational Site, Palm Desert

615 00

Aclaris Investigational Site, Brno

748 01

Aclaris Investigational Site, Hlučín

702 00

Aclaris Investigational Site, Ostrava

530 02

Aclaris Investigational Site, Pardubice

128 50

Aclaris Investigational Site, Prague

140 00

Aclaris Investigational Site, Prague

686 01

Aclaris Investigational Site, Uherské Hradiště

30-002

Aclaris Investigational Site, Krakow

22-600

Aclaris Investigational Site, Tomaszów Lubelski

20-362

Aclaris Investigational Site, Lublin

05-830

Aclaris Investigational Site, Nadarzyn

05-825

Aclaris Investigational Site, Grodzisk Mazowiecki

15-351

Aclaris Investigational Site, Bialystok

40-282

Aclaris Investigational Site, Katowice

82-300

Aclaris Investigational Site, Elblag

10-117

Aclaris Investigational Site, Olsztyn

61-113

Aclaris Investigational Site, Poznan

15-297

Aclaris Investigational Site, Bialystok

15-879

Aclaris Investigational Site, Bialystok

62-069

Aclaris Investigational Site, Dąbrówka

30-363

Aclaris Investigational Site, Krakow

20-607

Aclaris Investigational Site, Lublin

67-100

Aclaris Investigational Site, Nowa Sól

60-218

Aclaris Investigational Site, Poznan

60-446

Aclaris Investigational Site, Poznan

61-397

Aclaris Investigational Site, Poznan

96-500

Aclaris Investigational Site, Sochaczew

87-100

Aclaris Investigational Site, Torun

04-141

Aclaris Investigational Site, Warsaw

52-442

Aclaris Investigational Site, Wroclaw

Sponsors
All Listed Sponsors
lead

Aclaris Therapeutics, Inc.

INDUSTRY