A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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).
Key facts
- Study ID
- NCT06754462
- Run by
- Immunovant Sciences GmbH
- People needed
- 120
- Starts
- 2025-01-10
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
- Additional inclusion criteria are defined in the protocol.
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.
- Other, more specific exclusion criteria are defined in the protocol.
Where it is running
- Site Number - 1019 — Sun City, Arizona, United States
- Site Number - 1022 — Covina, California, United States
- Site Number - 1028 — San Leandro, California, United States
- Site Number - 1024 — Temecula, California, United States
- Site Number - 1033 — Tujunga, California, United States
- Site Number - 1023 — Whittier, California, United States
- Site Number - 1020 — Denver, Colorado, United States
- Site Number - 1015 — Jupiter, Florida, United States
- Site Number - 1002 — Miami, Florida, United States
- Site Number - 1027 — Plantation, Florida, United States
- Site Number - 1005 — Winter Park, Florida, United States
- Site Number - 1012 — Zephyrhills, Florida, United States
- Site Number - 1001 — Gainesville, Georgia, United States
- Site Number - 1034 — Chicago, Illinois, United States
- Site Number - 1006 — Cumberland, Maryland, United States
- Site Number - 1007 — Hagerstown, Maryland, United States
- Site Number - 1031 — Rockville, Maryland, United States
- Site Number - 1008 — Worcester, Massachusetts, United States
- Site Number - 1021 — Saint Clair Shores, Michigan, United States
- Site Number - 1030 — Kansas City, Missouri, United States
- Site Number - 1010 — Summit, New Jersey, United States
- Site Number - 1004 — Charlotte, North Carolina, United States
- Site Number - 1035 — Statesville, North Carolina, United States
- Site Number - 1000 — Duncansville, Pennsylvania, United States
- Site Number - 1018 — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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