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

April 21, 2026 updated by: Immunovant Sciences GmbH

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1417
        • Site Number - 5003
      • Buenos Aires, Argentina, 1425
        • Site Number - 5001
      • Buenos Aires, Argentina, C1046
        • Site Number -5004
      • Buenos Aires, Argentina, C1118AAF
        • Site Number - 5002
      • Buenos Aires, Argentina, C1180AAX
        • Site number - 5005
      • San Miguel de Tucumán, Argentina, 4000
        • Site Number - 5000
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Site Number - 5603
      • Plovdiv, Bulgaria, 4002
        • Site Number - 5605
      • Plovdiv, Bulgaria, 4004
        • Site Number - 5602
      • Rousse, Bulgaria, 7000
        • Site Number - 5604
      • Sevlievo, Bulgaria, 5400
        • Site Number - 5606
      • Sofia, Bulgaria, 1336
        • Site Number - 5600
      • Sofia, Bulgaria, 1680
        • Site Number - 5601
  • Czechia
      • Brno, Czechia, 638 00
        • Site Number - 3204
      • Ostrava, Czechia, 702 00
        • Site Number - 3202
      • Praha 2 Nove Mesto, Czechia, 128 50
        • Site Number - 3203
      • Uherské Hradiště, Czechia, 686 01
        • Site Number - 3201
      • Zlín, Czechia, 760 01
        • Site Number - 3200
  • Georgia
      • Tbilisi, Georgia, 0159
        • Site Number - 8000
      • Tbilisi, Georgia, 0160
        • Site Number - 8001
      • Tbilisi, Georgia, 0186
        • Site Number - 8003
  • Germany
      • Hamburg, Germany, 20095
        • Site Number - 6500
      • Ratingen, Germany, 40878
        • Site Number - 6501
  • Hungary
      • Budapest, Hungary, 1027
        • Site Number - 7554
      • Budapest, Hungary, 1027
        • Site Number - 7555
      • Hódmezővásárhely, Hungary, 6800
        • Site Number - 7550
      • Kecskemét, Hungary, 6000
        • Site Number - 7553
      • Székesfehérvár, Hungary, 8000
        • Site Number - 7551
      • Veszprém, Hungary, 8200
        • Site Number - 7552
  • Poland
      • Bialystok, Poland, 15-879
        • Site Number - 3005
      • Elblag, Poland, 82-300
        • Site Number - 3007
      • Lublin, Poland, 20-607
        • Site Number - 3009
      • Nadarzyn, Poland, 05-830
        • Site Number - 3006
      • Poznan, Poland, 60-848
        • Site Number - 3008
      • Poznan, Poland, 61-397
        • Site Number - 3000
      • Sochaczew, Poland, 96-500
        • Site Number - 3003
      • Warsaw, Poland, 02-665
        • Site Number - 3004
      • Wroclaw, Poland, 53-673
        • Site Number - 3002
  • Romania
      • Brasov, Romania, 500283
        • Site Number - 7500
      • Bucharest, Romania, 020475
        • Site Number - 7502
      • Râmnicu Vâlcea, Romania, 240636
        • Site Number - 7501
  • Spain
      • Barcelona, Spain, 08208
        • Site Number - 7104
      • Bilbao, Spain, 48013
        • Site Number - 7101
      • Málaga, Spain, 29009
        • Site Number - 7102
      • Seville, Spain, 41009
        • Site Number - 7100
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Site Number - 7000
      • London, United Kingdom, SE5 9RJ
        • Site Number - 7001
      • North Shields, United Kingdom, NE29 8NH
        • Site Number -7002
      • Wolverhampton, United Kingdom, WV10 0QP
        • Site Number - 7003
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Site Number - 1018
      • Sun City, Arizona, United States, 85351
        • Site Number - 1019
    • California
      • Covina, California, United States, 91722
        • Site Number - 1022
      • San Leandro, California, United States, 94578
        • Site Number - 1028
      • Temecula, California, United States, 92592
        • Site Number - 1024
      • Tujunga, California, United States, 91042
        • Site Number - 1033
      • Whittier, California, United States, 90602
        • Site Number - 1023
    • Colorado
      • Denver, Colorado, United States, 80230
        • Site Number - 1020
    • Florida
      • Jupiter, Florida, United States, 33458
        • Site Number - 1015
      • Miami, Florida, United States, 33143
        • Site Number - 1002
      • Plantation, Florida, United States, 33324
        • Site Number - 1027
      • Winter Park, Florida, United States, 32789
        • Site Number - 1005
      • Zephyrhills, Florida, United States, 33542
        • Site Number - 1012
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Site Number - 1001
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Site Number - 1034
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Site Number - 1006
      • Hagerstown, Maryland, United States, 21740
        • Site Number - 1007
      • Rockville, Maryland, United States, 20850
        • Site Number - 1031
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Site Number - 1008
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Site Number - 1021
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • Site Number - 1030
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Site Number - 1010
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Site Number - 1004
      • Statesville, North Carolina, United States, 28625
        • Site Number - 1035
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Number - 1000
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Site Number - 1016
      • Memphis, Tennessee, United States, 38119
        • Site Number - 1026
      • Murfreesboro, Tennessee, United States, 37128
        • Site Number - 1029
    • Texas
      • Allen, Texas, United States, 75013
        • Site Number - 1037
      • Colleyville, Texas, United States, 76034
        • Site Number - 1017
      • Katy, Texas, United States, 77494
        • Site Number - 1036
      • Mesquite, Texas, United States, 75150
        • Site Number - 1014
      • Tomball, Texas, United States, 77375
        • Site Number - 1013
      • Tomball, Texas, United States, 77377
        • Site Number - 1025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female participants of age >18 years will be enrolled.
  • Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
  • Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen joint count (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 synthetic disease-modifying antirheumatic drugs (DMARDs).

Additional inclusion criteria are defined in the protocol.

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered once weekly by subcutaneous injection.
Experimental: IMVT-1402 Dose 1
Drug: IMVT-1402
Administered once weekly by subcutaneous injection.
Experimental: IMVT-1402 Dose 2
Drug: IMVT-1402
Administered once weekly by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who maintain ACR20 response at Week 28
Time Frame: Week 28
Week 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28
Time Frame: Week 16 to Week 28
Week 16 to Week 28
Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28
Time Frame: Week 16 to Week 28
Week 16 to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1402-2601
  • 2024-515973-82-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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