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Active, not recruiting Phase 2

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

NCT06754462 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-01-10
Last updated
2026-04-22

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

IMVT-1402 →Placebo

IMVT-1402: Administered once weekly by subcutaneous injection.

Placebo: Administered once weekly by subcutaneous injection.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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). Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Proportion of participants who maintain ACR20 response at Week 28 — Week 28

Trial sites (83)

FacilityCityRegionStatus
Site Number - 1018 Mesa Arizona
Site Number - 1019 Sun City Arizona
Site Number - 1022 Covina California
Site Number - 1028 San Leandro California
Site Number - 1024 Temecula California
Site Number - 1033 Tujunga California
Site Number - 1023 Whittier California
Site Number - 1020 Denver Colorado
Site Number - 1015 Jupiter Florida
Site Number - 1002 Miami Florida
Site Number - 1027 Plantation Florida
Site Number - 1005 Winter Park Florida
Site Number - 1012 Zephyrhills Florida
Site Number - 1001 Gainesville Georgia
Site Number - 1034 Chicago Illinois
Site Number - 1006 Cumberland Maryland
Site Number - 1007 Hagerstown Maryland
Site Number - 1031 Rockville Maryland
Site Number - 1008 Worcester Massachusetts
Site Number - 1021 Saint Clair Shores Michigan
Site Number - 1030 Kansas City Missouri
Site Number - 1010 Summit New Jersey
Site Number - 1004 Charlotte North Carolina
Site Number - 1035 Statesville North Carolina
Site Number - 1000 Duncansville Pennsylvania
Site Number - 1016 Jackson Tennessee
Site Number - 1026 Memphis Tennessee
Site Number - 1029 Murfreesboro Tennessee
Site Number - 1037 Allen Texas
Site Number - 1017 Colleyville Texas
Site Number - 1036 Katy Texas
Site Number - 1014 Mesquite Texas
Site Number - 1013 Tomball Texas
Site Number - 1025 Tomball Texas
Site Number - 5003 Buenos Aires Argentina
Site Number - 5001 Buenos Aires Argentina
Site Number -5004 Buenos Aires Argentina
Site Number - 5002 Buenos Aires Argentina
Site Number - 5005 Buenos Aires Argentina
Site Number - 5000 San Miguel de Tucumán Argentina

+ 43 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06754462 on ClinicalTrials.gov ↗ ← All trials in Spain