Last updated 10 days ago
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
120 patients around the world
Available in Argentina, United States
The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as
measured by the American College of Rheumatology 20% (ACR20) response at Week 28.
The total duration of study participation is expected to be up to 86 weeks for an
individual participant with 16 weeks of open-label treatment, 12 weeks of blinded
randomized treatment, and 48 weeks of optional long-term extension treatment.
Immunovant Sciences GmbH
120Patients around the world
This study is for people with
Arthritis
Rheumatoid arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorImmunovant Sciences GmbH
Study typeInterventional
Conditions
Rheumatoid arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06754462
