Worried about your next IgG4-RD flare?
Learn more about a new study for patients with IgG4-RD which aims to prevent flares due to your condition.
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What is the INDIGO Study?
This is a research study for adults with active IgG4-related disease. The purpose of this study is to learn if a new investigational medicine called obexelimab can safely help prevent flares associated with IgG4-related disease.
Who can join this study?
The study will include at least 200 participants worldwide. You may be able to join the study if you:
Why Should I Participate?
We are looking for participants with IgG4-related disease to take part in important research.
By enrolling in this clinical study, you may be given an investigational treatment being evaluated for preventing active flares or symptoms such as:
Headache
Eye Pain
Weight loss
Rash
Swelling of Salivary Glands
Abdominal Pain
Coughing
General Tiredness
Lower Back Pain
What's Involved?
Phone Call
Upon initial eligibility, a PatientWing representative will call you and help guide you through additional eligibility questions.
Official Screening
The team at a participating research site will determine if you are eligible to participate in the study and what would be required for participation. Your flare will be treated, and tests will be done to see if the study is right for you.
Study
Throughout the study, you will take the study drug once a week for a little over a year.
How long does the study last?
The main study lasts about 1 year and 3 months (64 weeks). You may have the option to continue taking the active study drug at the end of your participation in Part A of the study by enrolling in the Part B, an open-label extension study.
Screening
Your flare will be treated, and tests will be done to see if the study is right for you.
Part A:
Study Treatment Period
You will take the study medicine (either active study drug or placebo) for 1 year. There will be study visits at the study clinic in between at-home study medicine administrations.
Part B:
Open-label Extension (OLE)
If you have completed all study visits up to Week 52 and meet eligibility, you will be asked if you wish to enroll in an open-label extension (OLE), where all patients will receive active study drug for 1 year.
Follow-Up
The study doctor will check on you after the final treatment visit.
How will my flare be treated?
Because having an active flare is a requirement for this study, you will be treated with steroids for 3 to 6 weeks to resolve your flare. If you are already on steroid treatment at the time of your Screening Visit, the study doctor may adjust your dose.
Once your flare has been resolved, your doctor will decide if you can start the Study Treatment Period. Your steroid dose will be slowly reduced over 8 weeks so that you can safely stop taking it.
If at any time you have a flare during the study, you can take rescue medication to help with your symptoms.
What happens during the study?
At study visits, you’ll generally answer questions and have health checks and tests. You won’t have every test at every visit. For Part A: Study Treatment Period, there will be a total of 17 scheduled clinic visits. For Part B: Open Label Extension, there will be a total of 15 scheduled clinic visits.
Health Review
Medication Review
Questionnaires
Vital Signs
Physical Exams
ECG heart test
Blood tests
Urine test
Pregnancy test
(If applicable)
What is the study medicine?
You will be randomly assigned, like tossing a coin, to receive obexelimab or placebo.
Having some patients take a placebo helps doctors and researchers tell the difference between what effects are caused by obexelimab and what effects may be happening by chance. Neither you nor your doctor will know which one you are receiving.
The study medicine (obexelimab or placebo) is given as an injection under the skin every 7 days. At first you will receive the injection at the study clinic. Then, you or a caregiver may be trained to give the injection at home, or you can continue to come to the study clinic for the injection.
About the study team
Zenas BioPharma
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and delivery of immune-based therapies for patients in need.
To learn more, visit
https://zenasbio.com
PatientWing
Our mission to bring better treatments to more people faster starts with you. We help sponsors find patients to participate in their clinical studies. With our focus on rare diseases and expertise in navigating the enrollment process, we're here for you every step of the way.
To learn more, visit
https://patientwing.comHave Questions?
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