RECRUITING

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).

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).

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

Covina

Site Number - 1022, Covina, California, United States, 91722

Fresno

Site Number - 1032, Fresno, California, United States, 93710

San Leandro

Site Number - 1028, San Leandro, California, United States, 94578

Temecula

Site Number - 1024, Temecula, California, United States, 92592

Tujunga

Site Number - 1033, Tujunga, California, United States, 91042

Whittier

Site Number - 1023, Whittier, California, United States, 90602

Denver

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

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

  • * 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).
  • * 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.

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