Are you treating patients with difficult-to-treat rheumatoid arthritis (RA)?
Talk to your patients about the EXPLORE research study
A Phase 2b, Multi-center, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Active, Difficult-to-treat, ACPA-Positive Rheumatoid Arthritis
Several locations across the country will be participating in Immunovant’s EXPLORE clinical research study of an injectable investigational treatment for patients with difficult-to-treat rheumatoid arthritis (RA). On this website, you will find general study information that may be of interest to you, your colleagues, and your patients.
The investigational treatment, IMVT-1402, has been evaluated in single and multiple doses in healthy volunteers, where it showed a favorable safety profile. Because the investigational treatment has the potential to reduce IgG levels by inhibiting the neonatal Fc receptor (FcRn), it is being developed for the treatment of autoantibody-mediated autoimmune diseases like RA.
The primary objective of this study is to evaluate the effects of the investigational treatment in participants as assessed by the American College of Rheumatology (ACR20) Response. Secondary objectives include evaluating the investigational treatment through Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) scores.
Participants will begin the study in Period 1, which is a 16-week, open-label treatment period. Participants who meet response criteria will enter Period 2 and be randomized 1:1:1 to the investigational treatment (600 or 300 mg) or placebo for 12 weeks.
During Period 1, participants will receive weekly injections of the investigational treatment. During Period 2, eligible participants will receive weekly injections of the investigational treatment or placebo. Participants who complete Period 2 may be eligible to continue in a 48-week extension period (Period 3) in which all participants will receive the investigational treatment in a blinded or open-label fashion. Total study participation may last up to 85 weeks (approximately 20 months).
How can you help?
The EXPLORE research study is enrolling approximately 120 patients, with approximately 80 sites included globally. The success of the EXPLORE research study depends on physicians to refer potential study participants.
Your patients may be eligible to apply if they meet the following criteria.
Key Eligibility Criteria
- ≥ 18 years of age
- Diagnosis of “definite RA” according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria
- ≥ 6/68 tender/painful joints and ≥ 6/66 swollen joints at screening and baseline
- C-reactive protein ≥ 1.5 x upper limit of normal (ULN) at screening
- DAS28-CRP > 4.1 at screening
- Elevated immunoglobulin G (IgG) + ACPA at screening
- Inadequate response to 2-3 classes of b/tsDMARDs as follows:
- Treated with a biologic TNF-α inhibitor (e.g., infliximab, certolizumab, golimumab, etanercept, adalimumab)
- Treated with a JAK inhibitor or at least 1 additional bDMARD other than a TNF-α inhibitor
- Have not had an inadequate response to rituximab
- Regular use of at least 1 csDMARD (MTX, hydroxychloroquine, sulfasalazine, and/or leflunomide) for at least 12 weeks prior to screening
Additional criteria will apply. All study-related visits, tests, and treatments will be provided at no cost. In addition, reimbursement for study-related time and travel may be provided.
Click on the button to see if you qualify
Should you refer one of your patients to us, please know that we will only provide treatment within the context of this study. For any concerns outside this study, participants will be directed back to their physician.
If you or your colleagues are interested in the EXPLORE research study or would like to refer a patient, please contact:
For additional study information, please visit clinicaltrials.gov.
Thank you for considering the EXPLORE research study for your patients.