ACTIVE_NOT_RECRUITING

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

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Conditions

Rheumatoid ArthritisAnticitrullinated protein autoantibodiesDifficult-to-treatAnti-FcRnIMVT-1402Autoimmune Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01-10
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06754462

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female participants of age \>18 years will be enrolled.
  2. * Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
  3. * 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.
  4. * C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.
  5. * Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
  6. * Inadequate response to at least 2 classes of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
  1. * Have received rituximab and experienced insufficient efficacy or loss of efficacy
  2. * History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA.
  3. * Active malignancy or history of malignancy within 5 years prior to Screening Visit.
  4. * Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
  5. * 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.
  6. * 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.

Contacts and Locations

Study Locations (Sites)

Site Number - 1018
Mesa, Arizona, 85210
United States
Site Number - 1019
Sun City, Arizona, 85351
United States
Site Number - 1022
Covina, California, 91722
United States
Site Number - 1028
San Leandro, California, 94578
United States
Site Number - 1024
Temecula, California, 92592
United States
Site Number - 1033
Tujunga, California, 91042
United States
Site Number - 1023
Whittier, California, 90602
United States
Site Number - 1020
Denver, Colorado, 80230
United States
Site Number - 1015
Jupiter, Florida, 33458
United States
Site Number - 1002
Miami, Florida, 33143
United States
Site Number - 1027
Plantation, Florida, 33324
United States
Site Number - 1005
Winter Park, Florida, 32789
United States
Site Number - 1012
Zephyrhills, Florida, 33542
United States
Site Number - 1001
Gainesville, Georgia, 30501
United States
Site Number - 1034
Chicago, Illinois, 60607
United States
Site Number - 1006
Cumberland, Maryland, 21502
United States
Site Number - 1007
Hagerstown, Maryland, 21740
United States
Site Number - 1031
Rockville, Maryland, 20850
United States
Site Number - 1008
Worcester, Massachusetts, 01605
United States
Site Number - 1021
Saint Clair Shores, Michigan, 48081
United States
Site Number - 1030
Kansas City, Missouri, 64151
United States
Site Number - 1010
Summit, New Jersey, 07901
United States
Site Number - 1004
Charlotte, North Carolina, 28207
United States
Site Number - 1035
Statesville, North Carolina, 28625
United States
Site Number - 1000
Duncansville, Pennsylvania, 16635
United States
Site Number - 1016
Jackson, Tennessee, 38305
United States
Site Number - 1026
Memphis, Tennessee, 38119
United States
Site Number - 1029
Murfreesboro, Tennessee, 37128
United States
Site Number - 1037
Allen, Texas, 75013
United States
Site Number - 1017
Colleyville, Texas, 76034
United States
Site Number - 1036
Katy, Texas, 77494
United States
Site Number - 1014
Mesquite, Texas, 75150
United States
Site Number - 1013
Tomball, Texas, 77375
United States
Site Number - 1025
Tomball, Texas, 77377
United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-01-10
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis