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If you have IgG4-related disease, you may be eligible to participate in the Indigo study, which involves an investigational product being studied to see if it may help prevent flares of symptoms that require treatment.
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.
The study will include at least 200 participants worldwide. You may be able to join the study if you:
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.
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.
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.
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.
