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

Description

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.

Conditions

Rheumatoid Arthritis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Anniston

Site Number - 1003, Anniston, Alabama, United States, 36207

Mesa

Site Number - 1018, Mesa, Arizona, United States, 85210

Sun City

Site Number - 1019, Sun City, Arizona, United States, 85351

Denver

Site Number - 1020, Denver, Colorado, United States, 80230

Jupiter

Site Number - 1015, Jupiter, Florida, United States, 33458

Miami

Site Number - 1002, Miami, Florida, United States, 33143

Winter Park

Site Number - 1005, Winter Park, Florida, United States, 32789

Zephyrhills

Site Number - 1012, Zephyrhills, Florida, United States, 33542

Gainesville

Site Number - 1001, Gainesville, Georgia, United States, 30501

Cumberland

Site Number - 1006, Cumberland, Maryland, United States, 21502

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
  • * 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.
  • * 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 non-immunosuppressive Fc-based therapeutic protein (e.g., 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2027-09