What is the BLOOM study? 

The BLOOM clinical study is researching an investigational treatment to see if it may work in treating Sjogren’s Disease. BLOOM is specifically for people with ‘primary’ Sjogren’s Disease, meaning that their disease developed on its own and is not the consequence of another disease.  
The purpose of the BLOOM clinical study is to learn more about the safety and effectiveness of the investigational medication, compared to placebo.  A placebo looks like the study medication but does not contain any active ingredient. 
The study medication is not approved by any regulatory health agency to treat Sjogren’s Disease. It is only available to people with Sjogren’s in clinical studies like this one. 

Who is eligible to participate in this clinical study? 

You may be able to take part if you: 
Are between 18 and 74 years old 
Have a diagnosis of primary Sjogren’s Disease for at least 1 year at screening  

Have not had a recent change to your treatment for primary Sjogren’s Disease (if you currently receive such treatment)  

Are not breastfeeding, pregnant, planning to become pregnant or get your partner pregnant during the study

Please note that additional criteria apply. The study doctor/staff can help you understand which criteria you need to meet to qualify for this study. 
All study-related visits, tests, and investigational treatment will be provided. You may be reimbursed for study visit-related parking, travel and meal expenses.  

What will happen during this clinical study?  

After the initial screening period, if you are eligible and agree to participate, you will begin the study.  
You have a 2 in 3 chance of receiving the investigational treatment, and a 1 in 3 chance of receiving placebo. You and the study doctor/staff will not know which investigational treatment (investigational medication or placebo) you are receiving. However, in the event of an emergency, this information can be provided.  
If you complete the study, you may have the option to enter a long-term extension (LTE) study.  
Throughout the study, you will have the option to receive some injections at home. The study doctor/staff will talk with you more about this.  
You will also be asked to attend about 17 clinic visits for health exams and tests to evaluate your health. After the first several visits, the remaining clinic visits will be scheduled on a monthly basis. Your total study participation (screening/treatment/follow-up) may last up to 57 weeks (approximately 14 months).