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

Last updated: April 30, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Joint Injuries

Rheumatoid Arthritis

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT06754462
IMVT-1402-2601
  • 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). 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 TJC and ≥ 6/66 SJC at both Screening and Baselinevisits.

  • C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.

  • DAS28-CRP > 4.1 at the Screening Visit.

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

  • Inadequate response to at least 2 classes of biologic/targeted synthetic 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 non-immunosuppressive Fc-based therapeutic protein (e.g., mAb or Fc-fusionprotein) within 4 weeks prior to or at Screening 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 study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety.

The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.

Connect with a study center

  • 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

    Site Not Available

  • Site Number - 6501

    Ratingen, 40878
    Germany

    Site Not Available

  • Site Number - 1011

    San Juan, 918
    Puerto Rico

    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 - 1003

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • 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 - 1022

    Covina, California 91722
    United States

    Site Not Available

  • Site Number - 1028

    San Leandro, California 94578
    United States

    Site Not Available

  • Site Number - 1024

    Temecula, California 92592
    United States

    Active - Recruiting

  • Site Number - 1023

    Whittier, California 90602
    United States

    Site Not Available

  • 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

    Site Not Available

  • Site Number - 1005

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Site Number - 1012

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Site Number - 1001

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Site Number - 1006

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Site Number - 1007

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Site Number - 1008

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Site Number - 1009

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • Site Number - 1021

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Site Number - 1010

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Site Number - 1004

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • 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 - 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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