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

Launched by IMMUNOVANT SCIENCES GMBH · Dec 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called IMVT-1402 for adults with rheumatoid arthritis (RA) that is difficult to manage. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and inflammation. The study aims to see how effective and safe IMVT-1402 is compared to a placebo (a treatment that doesn't contain the active drug) for improving symptoms in participants who have not responded well to other treatments.

To be eligible for this trial, participants must have a confirmed diagnosis of rheumatoid arthritis and show specific signs of the disease, such as joint tenderness and swelling. They should also have had inadequate results from at least two other types of RA treatments. Participants can expect to be part of a double-blind study, meaning neither they nor the researchers will know who is receiving the active treatment or the placebo. This helps ensure that the results are reliable. The trial is currently recruiting participants and welcomes individuals regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
• • C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.
• • DAS28-CRP \> 4.1 at the Screening Visit.
• • Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
• • Inadequate response to at least 2 classes of biologic/targeted synthetic 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 non-immunosuppressive Fc-based therapeutic protein (e.g., 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.