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?
Abstract geode illustration made up of lines with two icon butterflies, Who Can Participate, Multiple Sclerosis

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 approximately 40 weeks (10 months).

The study has 2 parts. During Part A, you will receive either obexelimab or a placebo. Both are given as an injection under the skin once a week. During Part B, you will receive obexelimab. No one will receive the placebo
during Part B.

Tests and health checks in this study

Screening

At least 1 clinic
visit

You will have 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

Weekly clinic visits
for 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.
You will come to the study clinic each week
for health checks and tests and to receive your
study treatment.


Study Treatment Period Part B

Weekly clinic visits
for 12 weeks

You will continue to come to the study clinic
once a week. You will receive obexelimab.
There will be no placebo.


Follow-up Period

1 clinic visit

There is one final study clinic visit 12 weeks
after your Week 24 visit (or your last Study
Treatment Visit).


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.

Pad of paper with a pen icon, Health Review, MoonStone Study, Multiple Sclerosis, MS

Health review

Pill bottle and two pill icons beside the bottle icon, Medicine Review, MoonStone Study, Multiple Sclerosis, MS

Medicine review

Outlined question mark icon, Questionnaires, MoonStone Study, Multiple Sclerosis, MS

Questionnaires

X-ray icon with a ribcage icon inside, Chest X-ray, MoonStone Study, Multiple Sclerosis, MS

Chest X-ray

Heart icon with a heartbeat line inside it, Vital Signs, MoonStone Study, Multiple Sclerosis, MS

Vital signs

Stethoscope icon, Physical Exam, MoonStone Study, Multiple Sclerosis, MS

Physical exam

Knee and reflex hammer icon, Neurological Exam, MoonStone Study, Multiple Sclerosis, MS

Neurological exam

Heart monitor screen icon, ECG Heart Test, MoonStone Study, Multiple Sclerosis, MS

ECG heart test

MRI machine icon, MRI Scan, MoonStone Study, Multiple Sclerosis, MS

MRI scan

Blood collection tube with a blood droplet icon, Blood Tests, MoonStone Study, Multiple Sclerosis, MS

Blood tests

Urine collection cup icon, Urine Tests, MoonStone Study, Multiple Sclerosis, MS

Urine test

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Pregnancy test (if applicable)

Vertebrae with a needle icon, Lumbar Pucture Optional, MoonStone Study, Multiple Sclerosis, MS

Lumbar puncture (optional)

ECG = electrocardiogram; MRI = magnetic resonance imaging.