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

NCT06754462 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMVT-1402-26012024-515973-82-00
• Study Type: interventional
• Target: 120
• Locations: 11 countries
• Sites: 83

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who maintain ACR20 response at Week 28

  Week 28

Secondary Outcomes (2)

• Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28

  Week 16 to Week 28

• Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28

  Week 16 to Week 28

Study Arms (3)

IMVT-1402 Dose 1

EXPERIMENTAL

Drug: IMVT-1402

IMVT-1402 Dose 2

EXPERIMENTAL

Drug: IMVT-1402

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMVT-1402 DRUG

Administered once weekly by subcutaneous injection.

IMVT-1402 Dose 1; IMVT-1402 Dose 2

Placebo DRUG

Administered once weekly by subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (83)

Site Number - 1018

Mesa, Arizona, 85210, United States

Location

Site Number - 1019

Sun City, Arizona, 85351, United States

Location

Site Number - 1022

Covina, California, 91722, United States

Location

Site Number - 1028

San Leandro, California, 94578, United States

Location

Site Number - 1024

Temecula, California, 92592, United States

Location

Site Number - 1033

Tujunga, California, 91042, United States

Location

Site Number - 1023

Whittier, California, 90602, United States

Location

Site Number - 1020

Denver, Colorado, 80230, United States

Location

Site Number - 1015

Jupiter, Florida, 33458, United States

Location

Site Number - 1002

Miami, Florida, 33143, United States

Location

Site Number - 1027

Plantation, Florida, 33324, United States

Location

Site Number - 1005

Winter Park, Florida, 32789, United States

Location

Site Number - 1012

Zephyrhills, Florida, 33542, United States

Location

Site Number - 1001

Gainesville, Georgia, 30501, United States

Location

Site Number - 1034

Chicago, Illinois, 60607, United States

Location

Site Number - 1006

Cumberland, Maryland, 21502, United States

Location

Site Number - 1007

Hagerstown, Maryland, 21740, United States

Location

Site Number - 1031

Rockville, Maryland, 20850, United States

Location

Site Number - 1008

Worcester, Massachusetts, 01605, United States

Location

Site Number - 1021

Saint Clair Shores, Michigan, 48081, United States

Location

Site Number - 1030

Kansas City, Missouri, 64151, United States

Location

Site Number - 1010

Summit, New Jersey, 07901, United States

Location

Site Number - 1004

Charlotte, North Carolina, 28207, United States

Location

Site Number - 1035

Statesville, North Carolina, 28625, United States

Location

Site Number - 1000

Duncansville, Pennsylvania, 16635, United States

Location

Site Number - 1016

Jackson, Tennessee, 38305, United States

Location

Site Number - 1026

Memphis, Tennessee, 38119, United States

Location

Site Number - 1029

Murfreesboro, Tennessee, 37128, United States

Location

Site Number - 1037

Allen, Texas, 75013, United States

Location

Site Number - 1017

Colleyville, Texas, 76034, United States

Location

Site Number - 1036

Katy, Texas, 77494, United States

Location

Site Number - 1014

Mesquite, Texas, 75150, United States

Location

Site Number - 1013

Tomball, Texas, 77375, United States

Location

Site Number - 1025

Tomball, Texas, 77377, United States

Location

Site Number - 5003

Buenos Aires, 1417, Argentina

Location

Site Number - 5001

Buenos Aires, 1425, Argentina

Location

Site Number -5004

Buenos Aires, C1046, Argentina

Location

Site Number - 5002

Buenos Aires, C1118AAF, Argentina

Location

Site Number - 5005

Buenos Aires, C1180AAX, Argentina

Location

Site Number - 5000

San Miguel de Tucumán, 4000, Argentina

Location

Site Number - 5603

Plovdiv, 4000, Bulgaria

Location

Site Number - 5605

Plovdiv, 4002, Bulgaria

Location

Site Number - 5602

Plovdiv, 4004, Bulgaria

Location

Site Number - 5604

Rousse, 7000, Bulgaria

Location

Site Number - 5606

Sevlievo, 5400, Bulgaria

Location

Site Number - 5600

Sofia, 1336, Bulgaria

Location

Site Number - 5601

Sofia, 1680, Bulgaria

Location

Site Number - 3204

Brno, 638 00, Czechia

Location

Site Number - 3202

Ostrava, 702 00, Czechia

Location

Site Number - 3203

Praha 2 Nove Mesto, 128 50, Czechia

Location

Site Number - 3201

Uherské Hradiště, 686 01, Czechia

Location

Site Number - 3200

Zlín, 760 01, Czechia

Location

Site Number - 8000

Tbilisi, 0159, Georgia

Location

Site Number - 8001

Tbilisi, 0160, Georgia

Location

Site Number - 8003

Tbilisi, 0186, Georgia

Location

Site Number - 6500

Hamburg, 20095, Germany

Location

Site Number - 6501

Ratingen, 40878, Germany

Location

Site Number - 7554

Budapest, 1027, Hungary

Location

Site Number - 7555

Budapest, 1027, Hungary

Location

Site Number - 7550

Hódmezővásárhely, 6800, Hungary

Location

Site Number - 7553

Kecskemét, 6000, Hungary

Location

Site Number - 7551

Székesfehérvár, 8000, Hungary

Location

Site Number - 7552

Veszprém, 8200, Hungary

Location

Site Number - 3005

Bialystok, 15-879, Poland

Location

Site Number - 3007

Elblag, 82-300, Poland

Location

Site Number - 3009

Lublin, 20-607, Poland

Location

Site Number - 3006

Nadarzyn, 05-830, Poland

Location

Site Number - 3008

Poznan, 60-848, Poland

Location

Site Number - 3000

Poznan, 61-397, Poland

Location

Site Number - 3003

Sochaczew, 96-500, Poland

Location

Site Number - 3004

Warsaw, 02-665, Poland

Location

Site Number - 3002

Wroclaw, 53-673, Poland

Location

Site Number - 7500

Brasov, 500283, Romania

Location

Site Number - 7502

Bucharest, 020475, Romania

Location

Site Number - 7501

Râmnicu Vâlcea, 240636, Romania

Location

Site Number - 7104

Barcelona, 08208, Spain

Location

Site Number - 7101

Bilbao, 48013, Spain

Location

Site Number - 7102

Málaga, 29009, Spain

Location

Site Number - 7100

Seville, 41009, Spain

Location

Site Number - 7000

Edinburgh, EH4 2XU, United Kingdom

Location

Site Number - 7001

London, SE5 9RJ, United Kingdom

Location

Site Number -7002

North Shields, NE29 8NH, United Kingdom

Location

Site Number - 7003

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: December 31, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); GE (3); CZ (5); DE (2); BU (7); ES (4); GB (4); RO (3); HU (6); AR (6); PL (9)