Are you living with Sjögren’s?
A new research study is enrolling those diagnosed with Sjögren’s.
While there are medications available to help manage the symptoms of Sjögren’s, there are currently no approved treatments that can slow the course of the disease. The Oasiz Program includes two research studies for patients with moderate-to-severe systemic symptoms and those with high symptomatic burden. These studies evaluate whether an investigational medicine may have an effect on the progression of the disease and improve quality of life. Your involvement could play a vital role in advancing our understanding of effective treatments.
Living With Sjögren’s
Sjögren’s is a chronic autoimmune disease,1,2 which means the body’s immune system attacks healthy tissues. In the case of Sjögren’s, the immune system usually targets the glands that create moisture in the mouth (saliva) and the eyes (tears).2 It may also affect other parts of the body, including the lungs, liver, pancreas, kidneys, gastrointestinal system, central nervous system and blood vessels.1
Because the symptoms may be similar to those of other conditions, Sjögren’s can be difficult to diagnose.1
Common Sjögren’s symptoms may include1-3:
- Dry eyes
- Dry mouth, dental problems
- Dry skin, rash
- Dry nasal passages and throat, and a dry cough
- Fatigue
- Joint and muscle pain, soreness
- Difficulty sleeping and/or night sweats
- Fever
- Weight loss
- Lymph node and/or salivary gland swelling
- Blood test abnormalities
Sjögren’s may occur along with other autoimmune diseases such as lupus or rheumatoid arthritis.1 This condition is more common in women than in men but can be diagnosed in all ages, races and genders.1,2
About the Oasiz Program
The Oasiz Studies are evaluating the safety and efficacy of an investigational medicine in people living with moderate-to-severe Sjögren’s. The investigational medicine works differently from other medicines for Sjögren’s. While currently available medicines may help to manage some symptoms, this investigational medicine is being evaluated to see if it may have an effect on the progression of the disease.
The research studies will last up to 60 weeks (14 months) and require up to 16 visits to the study site. After completing the Study Treatment Period, you may be eligible to join an extension study, during which all participants will receive the investigational medicine for a period of time.
You may be able to continue using the medicine you are currently taking during the research study. The study doctor can provide more details.
About the Investigational Medicine
The investigational medicine (Dazodalibep) or placebo is given intravenously (by IV) about every month. During the Study Treatment Period, there will be a two out of three (66%) chance of receiving the investigational medicine and a one out of three (33%) chance of receiving a placebo. (A placebo looks like the investigational medicine but contains no active medicine.)
You may be able to participate if you*:
- Are at least 18 years old (or the age of majority in your country)
- Have been diagnosed with Sjögren’s
- Experience moderate-to-severe Sjögren’s signs or symptoms such as dry mouth, dry eyes, fatigue, joint pain and/or other systemic symptoms
The two Oasiz Studies are similar, but there are some key differences.
The Oasiz-301 Study is for people who have traditional Sjögren’s symptoms (dryness, pain and fatigue) and/or at least one other systemic organ is affected (ie: lungs, kidney, nerves, skin, blood, etc).
The Oasiz-303 Study is for people who have traditional Sjögren’s symptoms (dryness, pain, and fatigue) with minimal systemic disease symptoms.
*The study doctor will evaluate your Sjögren’s symptoms, medical history and other assessments to determine which study may be the best fit for you.
Why Participate?
If you qualify and decide to take part, you will receive:
- All study-related care and the investigational medicine at no charge
- Regular monitoring of your Sjögren’s and overall health by physicians who specialize in Sjögren’s
- Reimbursement for transportation costs to attend study visits, as needed
- The opportunity to help advance scientific knowledge about Sjögren’s
Your participation in any research study is voluntary, and you are always free to withdraw at any time, for any reason, without impacting your access to treatment or other benefits to which you are entitled.
To learn more about the Oasiz Program and where it is being conducted, click the map below.
Frequently Asked Questions
This section will help answer some important questions you may have.
About the Oasiz Program
This research is being conducted to determine the safety and efficacy of an investigational medicine for Sjögren’s.
The investigational medicine works differently from other medicines for Sjögren’s. While current medicines may help manage symptoms, this investigational medicine is being evaluated to see if it may have an effect on the progression of the disease. The investigational medicine is given intravenously (by IV).
A placebo looks like the investigational medicine but contains no active medicine. Researchers use a placebo to see if the investigational medicine works better or is safer than taking nothing.
Each research study will last up to 60 weeks (14 months) and requires up to 16 visits to the study site. After completing the Study Treatment Period, you may be eligible to join an extension study, during which all participants will receive the investigational medicine for a period of time.
Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, information on the research study’s purpose, possible benefits and risks, assessments, procedures, etc. No study-related procedures can be done until you sign the Informed Consent Form. You will have the opportunity to ask questions of the study team so you can decide if participating is right for you.
Privacy, Stopping Participation, Costs and Permission
The information you provide will not be shared with anyone who is not directly associated with the Oasiz Studies without your permission, except as required by law or as set forth in the Informed Consent Form, the document you would sign before participating in the research study.
Yes, participation in research studies is always voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. If you do decide to leave the research study early, you should talk to your study doctor about leaving so that they can schedule a final evaluation.
No. However, all study-related care and the investigational medicine will be provided at no charge. You may receive a stipend at specific trial visits to be used to cover your time and expenses you incur (such as routine local travel and meals) due to your participation in the study. Additional reimbursement may be available for extensive travel/lodging expenses approved by the trial team and the Sponsor on a case-by-case basis. The study team can provide more information about this.
No, you do not need your doctor’s permission to participate. However, you will need the study doctor’s approval to participate based on an assessment of whether you qualify. If you do participate and give your consent, the study doctor can keep your regular doctor updated about your condition during the research study.
About Research Studies
A research study, also known as a clinical trial, is a scientific study that evaluates the safety and efficacy of an investigational medicine as well as how your body processes that medicine. Qualified doctors, nurses and other medical professionals are responsible for conducting the research study.
It is only through the completion of research studies that investigational medicines can be evaluated and, if proven safe and efficacious, approved for a particular use. Different regulatory bodies in different countries (such as the U.S. Food and Drug Administration [FDA]) will provide this approval after a thorough review. In order to ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review the detailed plans and goals for the research study.
An investigational medicine is a medicine that has not been approved for prescription use by regulatory or health authorities, such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA).
Only participants who meet all the required eligibility criteria for the research study may take part. The study team will review your medical history and current medical status against the eligibility criteria to determine if you are eligible. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.