An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on
the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy
female volunteers.

This study will investigate the potential effect of BAF312 on the
pharmacokinetics and pharmacodynamics of combined monophasic ethinylestradiol
(EE) and levonorgestrel (LVG), the components of a commonly prescribed, low
dose, oral contraceptive (OC) in
order to provide labeling information for women of child-bearing potential.

Objectives:
- To investigate whether BAF312 administered daily at a dose of 4 mg can affect
exposure (Cmax,ss and/or AUCtau) to a daily administered monophasic oral
contraceptive (OC) regimen containing 30 µg of ethinylestradiol (EE) and 150 µg
of levonorgestrel (LVG).
- To assess the effect of oral BAF312 (4 mg q.d.) on the pharmacodynamics of a
monophasic OC determined by Hoogland score, FSH, LH, estradiol, progesterone,
SHBG concentrations and ovarian follicle size.

The study employs an open-label, single center, single sequence, two- treatment
period design, in 24 healthy female subjects. The subjects will be exposed
sequentially to OC alone in period 1; BAF312 will be titrated up to 2 mg in the
last 6 days of period 1, then OC will be co-administered with BAF312 4 mg q.d
in period 2.

The study will start with a screening visit. During the screening visit
standard medical assessments including safety laboratory tests (blood draw,
urine collection), an alcohol breath test, urine drug screen, a physical
examination, ECG and a vital signs measurement will be performed. In addition
standard gynecological test will be performed.

After the subject passes all above mentioned tests, the subject will be
enrolled in the synchronization phase.

During the confinement period the subjects will receive the study medication,
will be asked on a regular basis for possible side effects, blood will be drawn
for safety and PK/PD measurements and the vital signs / ECG will be checked
regularly. During the outpatient periods, the subject will return in regular
intervals. During these visits the subjects will be asked for possible side
effects, blood will be drawn for safety and PK/PD
measurements, the vital signs/ECG will be checked.

Finally a follow-up examination will be performed. During this visit the
subjects will be asked for possible side effects, blood will be drawn for
safety, the vital signs/ECG will be checked and a physical examination will be
conducted.

The test medication has been previously tested in over 450 healthy human
subjects and over 300 patients of Multiple Sclerosis and
polymyositis/dermatomyositis. The test medication was generally well tolerated.
A number of side-effects, possibly linked to use of the test medication, were
reported. These side-effects included, in the majority of cases, nervous system
disorders (headache and dizziness), gastro intestinal disorders (nausea),
cardiac disorders (changes in heart rate and heart rhythm)) , alteration in
liver function, decrease in lymphocytes (white blood cells) count, increased
risk of infections and swelling of the retina (swelling of the retina was seen
in one case in a MS patient in phase II trial).

The OC will contain EE and LVG. The doses of EE (30 µg) and LVG (150 µg) are
widely used in clinical practice. The most common side effects reported for
oral OCs are: nausea, abdominal pain, increased weight, headache, depressed or
altered mood, breast pain or tenderness.

The blood collection procedures may cause discomfort or bruising. Occasionally,
fainting or an infection at the blood sampling site can occur.