Are you treating patients with Sjogren’s Disease?

Talk to your patients about the BLOOM clinical study

A Phase 2b, Multicentre, Randomised, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity

Multiple locations worldwide will be participating in Immunovant’s BLOOM clinical study of an investigational treatment for patients with Sjogren’s Disease (SjD). 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, is an FcRn inhibitor and has been evaluated in single and multiple doses in healthy volunteers. The investigational treatment is being studied to assess its potential to reduce IgG levels by inhibiting the neonatal Fc receptor (FcRn) and is being developed for the treatment of autoantibody-mediated autoimmune diseases like Sjogren’s.

The primary objective of this study is to evaluate the efficacy, safety and tolerability of an investigational medication in adult participants with primary Sjogren’s Disease with moderate to severe systemic disease activity as assessed by the change from baseline in Clin EULAR SS disease activity index (clinESSDAI) score as compared to a placebo. Secondary objectives include evaluating how effective the investigational medication is in reducing the disease activity of Sjogren’s disease compared to a placebo as assessed by the change from baseline in Physician Global Assessment of Disease Activity (PhGA) score. 

Two dose levels will be evaluated over a 48-week blinded treatment period. Eligible participants will be randomised to receive once weekly injections of a higher and lower dose of the investigational medication or a placebo. Participants who complete the initial study treatment period through the Week 48 visit will be given an opportunity to enter an optional LTE treatment period. Total study participation may last up to 104 weeks. Participants who do not enter the LTE period will have a follow-up period that lasts 4 weeks after the last dose.

How can you help?

The BLOOM clinical study is enrolling approximately 180 participants, with approximately 100 sites included globally. The success of the BLOOM clinical study depends on doctors to refer potential study participants.

Your patients may be eligible to apply if they meet the following criteria.

Key Eligibility Criteria

Are ≥ 18 to < 75 years of age at the time of signing the Informed Conent Form (ICF). 
Have a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR)Classification Criteria for Primary Sjogren’s Syndrome at the time of screening. 
Have moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit (participants must have at least “low” activity in ≥ 1 of the following domains: cutaneous, articular, glandular, constitutional and lymphadenopathy).  
Are seropositive for antibodies to Sjogren’s syndrome-related antigen A (SSA) / anti-Sjogren’s-syndrome-related antigen A (Ro) at the Screening Visit. Note: Participants are eligible if they are seropositive for either Ro52 or Ro60.
Have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 mL/min at the Screening Visit. 
If receiving medication(s) for primary SjD, alone or in combination, are on a stable dose for a minimum period of time prior to the Screening Visit and are expected to remain on a stable dose throughout the study (this dose may be adjusted for safety reasons).

Additional criteria will apply. All study-related visits, tests and investigational treatment will be provided during the study.

Click on the button to take a pre-screener and see if your patient qualifies.

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 doctor.

If you or your colleagues are interested in the BLOOM clinical study or would like to refer a patient, please contact:

[email protected]

For additional study information, please visit clinicaltrials.gov.  

Thank you for considering the BLOOM clinical study for your patients.