A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

Last updated: July 15, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

IMVT-1402

Placebo

Clinical Study ID

NCT06754462
IMVT-1402-2601
2024-515973-82-00
  • Ages > 18
  • All Genders

Study Summary

This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and Female participants of age >18 years will be enrolled.

  • Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance ofAssociations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.

  • Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen jointcount (SJC) at both Screening and Baseline visits.

  • C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.

  • Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.

  • Inadequate response to at least 2 classes of biologic/targeted syntheticdisease-modifying antirheumatic drugs (DMARDs).

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have received rituximab and experienced insufficient efficacy or loss of efficacy

  • History of any chronic inflammatory arthritis with onset prior to age 18 or historyof acute inflammatory joint disease of different origin from RA.

  • Active malignancy or history of malignancy within 5 years prior to Screening Visit.

  • Medical history of primary immunodeficiency, T cell or humoral, including commonvariable immunodeficiency.

  • Used any nonimmunosuppressive fragment crystallizable (Fc)-based therapeutic protein (e.g., monoclonal antibody [mAb] or Fc-fusion protein) within 4 weeks prior to or atScreening Visit.

  • Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or havea documented history of non-response to prior anti-FcRn treatment.

Other, more specific exclusion criteria are defined in the protocol.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: IMVT-1402
Phase: 2
Study Start date:
January 10, 2025
Estimated Completion Date:
September 30, 2027

Study Description

The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28.

The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.

Connect with a study center

  • Site Number - 5602

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Site Number - 5603

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Site Number - 5605

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Site Number - 5604

    Ruse, 7000
    Bulgaria

    Active - Recruiting

  • Site Number - 5606

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • Site Number - 5600

    Sofia, 1336
    Bulgaria

    Active - Recruiting

  • Site Number - 5601

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Site Number - 3204

    Brno, 638 00
    Czechia

    Active - Recruiting

  • Site Number - 3202

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Site Number - 3203

    Praha 2 Nové Město, 128 50
    Czechia

    Site Not Available

  • Site Number - 3201

    Uherské Hradiště, 686 01
    Czechia

    Active - Recruiting

  • Site Number - 3200

    Zlín, 760 01
    Czechia

    Active - Recruiting

  • Site Number - 8000

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Site Number - 8001

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Site Number - 8002

    Tbilisi, 0102
    Georgia

    Site Not Available

  • Site Number - 8003

    Tbilisi, 0186
    Georgia

    Site Not Available

  • Site Number - 6500

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Site Number - 6501

    Ratingen, 40878
    Germany

    Site Not Available

  • Site Number - 7554

    Budapest, 1027
    Hungary

    Site Not Available

  • Site Number - 7555

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Site Number - 7550

    Hódmezővásárhely, 6800
    Hungary

    Site Not Available

  • Site Number - 7553

    Kecskemét, 6000
    Hungary

    Site Not Available

  • Site Number - 7551

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Site Number - 7552

    Veszprém, 8200
    Hungary

    Site Not Available

  • Site Number - 3001

    Białystok, 15-077
    Poland

    Site Not Available

  • Site Number - 3005

    Białystok, 15-879
    Poland

    Active - Recruiting

  • Site Number - 3007

    Elbląg, 82-300
    Poland

    Site Not Available

  • Site Number - 3006

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Site Number - 3000

    Poznań, 61-397
    Poland

    Site Not Available

  • Site Number - 3008

    Poznań, 60-848
    Poland

    Site Not Available

  • Site Number - 3003

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Site Number - 3004

    Warszawa, 02-665
    Poland

    Site Not Available

  • Site Number - 3002

    Wrocław, 53-673
    Poland

    Active - Recruiting

  • Site Number - 1011

    San Juan, 918
    Puerto Rico

    Site Not Available

  • Site Number - 7500

    Braşov, 500283
    Romania

    Active - Recruiting

  • Site Number - 7501

    Râmnicu Vâlcea, 240636
    Romania

    Site Not Available

  • Site Number - 7101

    Bilbao, 48013
    Spain

    Site Not Available

  • Site Number - 7102

    Málaga, 29009
    Spain

    Site Not Available

  • Site Number - 7100

    Sevilla, 41009
    Spain

    Site Not Available

  • Site Number - 7000

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Site Number - 7001

    London, SE5 9RJ
    United Kingdom

    Site Not Available

  • Site Number -7002

    North Shields, NE29 8NH
    United Kingdom

    Site Not Available

  • Site Number - 7003

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Site Number - 1003

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Site Number - 1018

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Site Number - 1019

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Site Number - 1022

    Covina, California 91722
    United States

    Active - Recruiting

  • Site Number - 1032

    Fresno, California 93710
    United States

    Site Not Available

  • Site Number - 1028

    San Leandro, California 94578
    United States

    Active - Recruiting

  • Site Number - 1024

    Temecula, California 92592
    United States

    Active - Recruiting

  • Site Number - 1033

    Tujunga, California 91042
    United States

    Active - Recruiting

  • Site Number - 1023

    Whittier, California 90602
    United States

    Active - Recruiting

  • Site Number - 1020

    Denver, Colorado 80230
    United States

    Active - Recruiting

  • Site Number - 1015

    Jupiter, Florida 33458
    United States

    Active - Recruiting

  • Site Number - 1002

    Miami, Florida 33143
    United States

    Active - Recruiting

  • Site Number - 1027

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Site Number - 1005

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Site Number - 1012

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Site Number - 1001

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Site Number - 1034

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Site Number - 1006

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Site Number - 1007

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Site Number - 1031

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Site Number - 1008

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Site Number - 1009

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Site Number - 1021

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Site Number - 1030

    Kansas City, Missouri 64151
    United States

    Active - Recruiting

  • Site Number - 1010

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Site Number - 1004

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Site Number - 1035

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Site Number - 1000

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Site Number - 1016

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Site Number - 1026

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Site Number - 1029

    Murfreesboro, Tennessee 37128
    United States

    Active - Recruiting

  • Site Number -1029

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Site Number - 1017

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • Site Number - 1014

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Site Number - 1013

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Site Number - 1025

    Tomball, Texas 77377
    United States

    Active - Recruiting

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