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Clinical Trials in the UK / NCT06754462
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 UK tracker
Sponsor
Immunovant Sciences GmbH
Phase
Phase 2
Started
2025-01-10
Last updated
2026-04-22

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

IMVT-1402Placebo

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)

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.

More Immunovant Sciences GmbH trials in the UK

Other trials for the same condition

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 the UK