What is the MoonStone Study?

The MoonStone Study is a type of research study called a clinical trial. The purpose of this study is to learn if a new investigational study drug called obexelimab can safely help treat adults with MS.

Already enrolled?

Who can participate?

The study is open to adults with MS.

Age

18 to 60 years of age

Also...

There are other requirements. The study doctor will discuss them with you.

Diagnosis

Multiple sclerosis

What happens
during the study?

Your participation in this study, including the Screening
Visit and Follow-up Visit, will be up to 92 weeks (1.8 years).

During Part A of the study, you will receive either
obexelimab or a placebo. Both are given as an injection
under the skin once a week.

During Parts B and C, you will receive obexelimab. No
one will receive the placebo during Parts B and C.

You and your study doctor will decide if you should come
to the study clinic for weekly injections or if you can give
yourself injections at home. If you are injecting at home,
the study staff will call each week to check on you.

Tests and health checks in this study

Screening

You will have at least 1 clinic visit for health checks and tests to see if you qualify for the study. If you do, you will start the study treatment within 4 weeks of your Screening Visit.

Study Treatment Period Part A

12 weeks

You will be assigned by chance to receive
obexelimab or a placebo. You have a 67%
chance of being in the obexelimab group and
a 33% chance of being in the placebo group.

Study Treatment Period Part B

12 weeks

You will receive obexelimab. There will be no
placebo. You will continue to see the study
doctor on a schedule.

Open-Label Extension Part C

52 weeks

You will continue to take obexelimab and see
the study doctor.

Follow-up Period

There is one final study clinic visit 12 weeks
after your last visit in Part C.

What kind of tests and health checks can I expect?

During the study, you will have tests and procedures performed to check your health, gather data on the effects of the study drug, and to see if you are able to continue taking the study drug. Each study visit will include SOME or ALL of the following tests and procedures.