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

Last updated: November 5, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Joint Injuries

Treatment

Placebo

IMVT-1402

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: Placebo
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 - 5001

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • Site Number - 5002

    Buenos Aires, C1118AAF
    Argentina

    Site Not Available

  • Site Number - 5003

    Buenos Aires, 1417
    Argentina

    Site Not Available

  • Site Number - 5005

    Buenos Aires, C1180AAX
    Argentina

    Site Not Available

  • Site Number - 5001

    Buenos Aires 3435910, 1425
    Argentina

    Site Not Available

  • Site Number - 5002

    Buenos Aires 3435910, C1118AAF
    Argentina

    Site Not Available

  • Site Number - 5003

    Buenos Aires 3435910, 1417
    Argentina

    Site Not Available

  • Site Number - 5005

    Buenos Aires 3435910, C1180AAX
    Argentina

    Site Not Available

  • Site Number -5004

    Buenos Aires 3435910, C1046
    Argentina

    Site Not Available

  • Site Number - 5000

    San Miguel de Tucumán 3836873, 4000
    Argentina

    Site Not Available

  • Site Number - 5000

    Tucuman, 4000
    Argentina

    Site Not Available

  • Site Number - 5602

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Site Number - 5603

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Site Number - 5605

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Site Number - 5602

    Plovdiv 728193, 4004
    Bulgaria

    Active - Recruiting

  • Site Number - 5603

    Plovdiv 728193, 4000
    Bulgaria

    Active - Recruiting

  • Site Number - 5605

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

  • Site Number - 5604

    Rousse 727523, 7000
    Bulgaria

    Active - Recruiting

  • Site Number - 5604

    Ruse, 7000
    Bulgaria

    Site Not Available

  • Site Number - 5606

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • Site Number - 5606

    Sevlievo 727337, 5400
    Bulgaria

    Active - Recruiting

  • Site Number - 5600

    Sofia, 1336
    Bulgaria

    Active - Recruiting

  • Site Number - 5601

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Site Number - 5600

    Sofia 727011, 1336
    Bulgaria

    Active - Recruiting

  • Site Number - 5601

    Sofia 727011, 1680
    Bulgaria

    Active - Recruiting

  • Site Number - 3203

    Nové Město, Praha 2 128 50
    Czechia

    Site Not Available

  • Site Number - 3204

    Brno, 638 00
    Czechia

    Site Not Available

  • Site Number - 3204

    Brno 3078610, 638 00
    Czechia

    Active - Recruiting

  • Site Number - 3202

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Site Number - 3202

    Ostrava 3068799, 702 00
    Czechia

    Active - Recruiting

  • Site Number - 3203

    Praha 2 Nove Mesto, 128 50
    Czechia

    Active - Recruiting

  • Site Number - 3203

    Praha 2 Nové Město, 128 50
    Czechia

    Site Not Available

  • Site Number - 3201

    Uherské Hradiště, 686 01
    Czechia

    Site Not Available

  • Site Number - 3201

    Uherské Hradiště 3063739, 686 01
    Czechia

    Active - Recruiting

  • Site Number - 3200

    Zlín, 760 01
    Czechia

    Site Not Available

  • Site Number - 3200

    Zlín 3061370, 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 - 8000

    Tbilisi 611717, 0159
    Georgia

    Active - Recruiting

  • Site Number - 8001

    Tbilisi 611717, 0160
    Georgia

    Active - Recruiting

  • Site Number - 8003

    Tbilisi 611717, 0186
    Georgia

    Active - Recruiting

  • Site Number - 6500

    Hamburg, 20095
    Germany

    Site Not Available

  • Site Number - 6500

    Hamburg 2911298, 20095
    Germany

    Active - Recruiting

  • Site Number - 6501

    Ratingen, 40878
    Germany

    Site Not Available

  • Site Number - 6501

    Ratingen 2850174, 40878
    Germany

    Active - Recruiting

  • Site Number - 7554

    Budapest, 1027
    Hungary

    Site Not Available

  • Site Number - 7555

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Site Number - 7554

    Budapest 3054643, 1027
    Hungary

    Active - Recruiting

  • Site Number - 7555

    Budapest 3054643, 1027
    Hungary

    Active - Recruiting

  • Site Number - 7550

    Hódmezővásárhely, 6800
    Hungary

    Site Not Available

  • Site Number - 7550

    Hódmezővásárhely 719965, 6800
    Hungary

    Active - Recruiting

  • Site Number - 7553

    Kecskemét, 6000
    Hungary

    Site Not Available

  • Site Number - 7553

    Kecskemét 3050434, 6000
    Hungary

    Active - Recruiting

  • Site Number - 7551

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Site Number - 7551

    Székesfehérvár 3044774, 8000
    Hungary

    Active - Recruiting

  • Site Number - 7552

    Veszprém, 8200
    Hungary

    Site Not Available

  • Site Number - 7552

    Veszprém 3042929, 8200
    Hungary

    Active - Recruiting

  • Site Number - 3005

    Bialystok 776069, 15-879
    Poland

    Active - Recruiting

  • Site Number - 3001

    Białystok, 15-077
    Poland

    Site Not Available

  • Site Number - 3005

    Białystok, 15-879
    Poland

    Site Not Available

  • Site Number - 3007

    Elblag 3099759, 82-300
    Poland

    Active - Recruiting

  • Site Number - 3007

    Elbląg, 82-300
    Poland

    Site Not Available

  • Site Number - 3009

    Lublin 765876, 20-607
    Poland

    Site Not Available

  • Site Number - 3006

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Site Number - 3006

    Nadarzyn 764194, 05-830
    Poland

    Active - Recruiting

  • Site Number - 3000

    Poznan 3088171, 61-397
    Poland

    Active - Recruiting

  • Site Number - 3008

    Poznan 3088171, 60-848
    Poland

    Active - Recruiting

  • Site Number - 3000

    Poznań, 61-397
    Poland

    Active - Recruiting

  • Site Number - 3008

    Poznań, 60-848
    Poland

    Site Not Available

  • Site Number - 3003

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Site Number - 3003

    Sochaczew 758682, 96-500
    Poland

    Active - Recruiting

  • Site Number - 3004

    Warsaw 756135, 02-665
    Poland

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  • Site Number - 3004

    Warszawa, 02-665
    Poland

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  • Site Number - 3002

    Wroclaw 3081368, 53-673
    Poland

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  • Site Number - 3002

    Wrocław, 53-673
    Poland

    Site Not Available

  • Site Number - 1011

    San Juan, 918
    Puerto Rico

    Site Not Available

  • Site Number - 7500

    Brasov 683844, 500283
    Romania

    Active - Recruiting

  • Site Number - 7500

    Braşov, 500283
    Romania

    Site Not Available

  • Site Number - 7502

    Bucharest 683506, 020475
    Romania

    Site Not Available

  • Site Number - 7501

    Râmnicu Vâlcea, 240636
    Romania

    Site Not Available

  • Site Number - 7501

    Râmnicu Vâlcea 668872, 240636
    Romania

    Active - Recruiting

  • Site Number - 7104

    Barcelona 3128760, 08208
    Spain

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  • Site Number - 7101

    Bilbao, 48013
    Spain

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  • Site Number - 7101

    Bilbao 3128026, 48013
    Spain

    Active - Recruiting

  • Site Number - 7102

    Málaga, 29009
    Spain

    Site Not Available

  • Site Number - 7102

    Málaga 2514256, 29009
    Spain

    Site Not Available

  • Site Number - 7100

    Sevilla, 41009
    Spain

    Site Not Available

  • Site Number - 7100

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Site Number - 7000

    Edinburgh, EH4 2XU
    United Kingdom

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  • Site Number - 7000

    Edinburgh 2650225, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Site Number - 7001

    London, SE5 9RJ
    United Kingdom

    Site Not Available

  • Site Number - 7001

    London 2643743, SE5 9RJ
    United Kingdom

    Active - Recruiting

  • Site Number -7002

    North Shields, NE29 8NH
    United Kingdom

    Site Not Available

  • Site Number -7002

    North Shields 2641267, NE29 8NH
    United Kingdom

    Active - Recruiting

  • Site Number - 7003

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Site Number - 7003

    Wolverhampton 2633691, WV10 0QP
    United Kingdom

    Site Not Available

  • Site Number - 1003

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Site Number - 1018

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Site Number - 1019

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Site Number - 1018

    Mesa 5304391, Arizona 5551752 85210
    United States

    Active - Recruiting

  • Site Number - 1019

    Sun City 5316201, Arizona 5551752 85351
    United States

    Active - Recruiting

  • Site Number - 1022

    Covina, California 91722
    United States

    Site Not Available

  • Site Number - 1032

    Fresno, California 93710
    United States

    Site Not Available

  • Site Number - 1028

    San Leandro, California 94578
    United States

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  • Site Number - 1024

    Temecula, California 92592
    United States

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  • Site Number - 1033

    Tujunga, California 91042
    United States

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  • Site Number - 1023

    Whittier, California 90602
    United States

    Site Not Available

  • Site Number - 1022

    Covina 5340175, California 5332921 91722
    United States

    Active - Recruiting

  • Site Number - 1028

    San Leandro 5392263, California 5332921 94578
    United States

    Active - Recruiting

  • Site Number - 1024

    Temecula 5401395, California 5332921 92592
    United States

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  • Site Number - 1033

    Tujunga 5403767, California 5332921 91042
    United States

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  • Site Number - 1023

    Whittier 5409059, California 5332921 90602
    United States

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  • Site Number - 1020

    Denver, Colorado 80230
    United States

    Site Not Available

  • Site Number - 1020

    Denver 5419384, Colorado 5417618 80230
    United States

    Active - Recruiting

  • Site Number - 1015

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Site Number - 1002

    Miami, Florida 33143
    United States

    Site Not Available

  • Site Number - 1027

    Plantation, Florida 33324
    United States

    Site Not Available

  • Site Number - 1005

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Site Number - 1012

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Site Number - 1015

    Jupiter 4160610, Florida 4155751 33458
    United States

    Active - Recruiting

  • Site Number - 1002

    Miami 4164138, Florida 4155751 33143
    United States

    Active - Recruiting

  • Site Number - 1027

    Plantation 4168782, Florida 4155751 33324
    United States

    Active - Recruiting

  • Site Number - 1005

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Site Number - 1012

    Zephyrhills 4178941, Florida 4155751 33542
    United States

    Active - Recruiting

  • Site Number - 1001

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Site Number - 1001

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Active - Recruiting

  • Site Number - 1034

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Site Number - 1034

    Chicago 4887398, Illinois 4896861 60607
    United States

    Active - Recruiting

  • Site Number - 1006

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Site Number - 1007

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Site Number - 1031

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Site Number - 1006

    Cumberland 4352681, Maryland 4361885 21502
    United States

    Active - Recruiting

  • Site Number - 1007

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

  • Site Number - 1031

    Rockville 4367175, Maryland 4361885 20850
    United States

    Active - Recruiting

  • Site Number - 1008

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Site Number - 1008

    Worcester 4956184, Massachusetts 6254926 01605
    United States

    Active - Recruiting

  • Site Number - 1009

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Site Number - 1021

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Site Number - 1021

    Saint Clair Shores 5010978, Michigan 5001836 48081
    United States

    Active - Recruiting

  • Site Number - 1030

    Kansas City, Missouri 64151
    United States

    Site Not Available

  • Site Number - 1030

    Kansas City 4393217, Missouri 4398678 64151
    United States

    Active - Recruiting

  • Site Number - 1010

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Site Number - 1010

    Summit 5105127, New Jersey 5101760 07901
    United States

    Active - Recruiting

  • Site Number - 1004

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Site Number - 1035

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Site Number - 1004

    Charlotte 4460243, North Carolina 4482348 28207
    United States

    Active - Recruiting

  • Site Number - 1035

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Active - Recruiting

  • Site Number - 1000

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Site Number - 1000

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Active - Recruiting

  • Site Number - 1016

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Site Number - 1026

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Site Number - 1029

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Site Number -1029

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Site Number - 1016

    Jackson 4632595, Tennessee 4662168 38305
    United States

    Active - Recruiting

  • Site Number - 1026

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

  • Site Number - 1029

    Murfreesboro 4644312, Tennessee 4662168 37128
    United States

    Active - Recruiting

  • Site Number - 1017

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Site Number - 1014

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Site Number - 1013

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Site Number - 1025

    Tomball, Texas 77377
    United States

    Site Not Available

  • Site Number - 1037

    Allen 4670300, Texas 4736286 75013
    United States

    Active - Recruiting

  • Site Number - 1017

    Colleyville 4682478, Texas 4736286 76034
    United States

    Active - Recruiting

  • Site Number - 1036

    Katy 4702732, Texas 4736286 77494
    United States

    Site Not Available

  • Site Number - 1014

    Mesquite 4710826, Texas 4736286 75150
    United States

    Active - Recruiting

  • Site Number - 1013

    Tomball 4737094, Texas 4736286 77375
    United States

    Active - Recruiting

  • Site Number - 1025

    Tomball 4737094, Texas 4736286 77377
    United States

    Active - Recruiting

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