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Phase 2

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

Sponsor:

Immunovant Sciences GmbH

Code:

NCT06754462

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMVT-1402

Placebo

Study Details

Brief 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).

Conditions

Rheumatoid Arthritis

Study ID

NCT06754462

Start date

Jan 10, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IMVT-1402 Dose 1

experimental: IMVT-1402 Dose 2

placebo comparator: Placebo

Interventions

IMVT-1402

Administered once weekly by subcutaneous injection.

Placebo

Administered once weekly by subcutaneous injection.

Primary outcome measure

Proportion of participants who maintain ACR20 response at Week 28 [ Time Frame: Week 28 ]

Central Contacts and Locations

Central contacts

Central Study Contact

18007970414 clinicaltrials@immunovant.com

Locations

Site Number - 1018

Recruiting

Mesa, Arizona, United States, 85210

Site Number - 1019

Recruiting

Sun City, Arizona, United States, 85351

Site Number - 1022

Recruiting

Covina, California, United States, 91722

Site Number - 1028

Recruiting

San Leandro, California, United States, 94578

Site Number - 1024

Recruiting

Temecula, California, United States, 92592

Site Number - 1033

Recruiting

Tujunga, California, United States, 91042

Site Number - 1023

Recruiting

Whittier, California, United States, 90602

Site Number - 1020

Recruiting

Denver, Colorado, United States, 80230

Site Number - 1015

Recruiting

Jupiter, Florida, United States, 33458

Site Number - 1002

Recruiting

Miami, Florida, United States, 33143

Site Number - 1027

Recruiting

Plantation, Florida, United States, 33324

Site Number - 1005

Recruiting

Winter Park, Florida, United States, 32789

Site Number - 1012

Recruiting

Zephyrhills, Florida, United States, 33542

Site Number - 1001

Recruiting

Gainesville, Georgia, United States, 30501

Site Number - 1034

Recruiting

Chicago, Illinois, United States, 60607

Site Number - 1006

Recruiting

Cumberland, Maryland, United States, 21502

Site Number - 1007

Recruiting

Hagerstown, Maryland, United States, 21740

Site Number - 1031

Recruiting

Rockville, Maryland, United States, 20850

Site Number - 1008

Recruiting

Worcester, Massachusetts, United States, 01605

Site Number - 1021

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Site Number - 1030

Recruiting

Kansas City, Missouri, United States, 64151

Site Number - 1010

Recruiting

Summit, New Jersey, United States, 07901

Site Number - 1004

Recruiting

Charlotte, North Carolina, United States, 28207

Site Number - 1035

Recruiting

Statesville, North Carolina, United States, 28625

Site Number - 1000

Recruiting

Duncansville, Pennsylvania, United States, 16635

Site Number - 1016

Recruiting

Jackson, Tennessee, United States, 38305

Site Number - 1026

Recruiting

Memphis, Tennessee, United States, 38119

Site Number - 1029

Recruiting

Murfreesboro, Tennessee, United States, 37128

Site Number - 1037

Recruiting

Allen, Texas, United States, 75013

Site Number - 1017

Recruiting

Colleyville, Texas, United States, 76034

Site Number - 1014

Recruiting

Mesquite, Texas, United States, 75150

Site Number - 1013

Recruiting

Tomball, Texas, United States, 77375

Site Number - 1025

Recruiting

Tomball, Texas, United States, 77377

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

Rheumatoid Arthritis
Anticitrullinated protein autoantibodies
Difficult-to-treat
Anti-FcRn
IMVT-1402
Autoimmune Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Immunovant Sciences GmbH on 2025-11-06.