Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Anticitrullinated protein autoantibodies, Difficult-to-treat, Anti-FcRn, IMVT-1402, Autoimmune Diseases, Imeroprubart
Brief 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).
Detailed description
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.
Interventions
DRUGIMVT-1402
Administered once weekly by subcutaneous injection.
DRUGPlacebo
Administered once weekly by subcutaneous injection.
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who maintain ACR20 response at Week 28 | Week 28 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28 | Week 16 to Week 28 |
| Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28 | Week 16 to Week 28 |
Countries
Argentina, Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Romania, Spain, United Kingdom, United States
Outcome results
None listed