A Phase II Randomized, Double -Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

Inclusion Criteria

Inclusion criteria:

- Patients with newly diagnosed PVNS with, at least, one measurable site of disease on
MRI.

- Patients expected to get surgery.

- Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood
pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.

- Patients with normal level of serum ionized calcium and phosphate.

- Women of child-bearing potential must use highly effective contraception during the
study and for 84 days after the study drug infusion.

Exclusion criteria:

- Patients with major surgery less than 3 months prior to start study drug or who have
still side effects of such therapy.

- Presence of systemic illness precluding definitive surgery or increasing the risk to
patients due to potential immunosuppression.

- Use previously of intra-articular treatment within 4 weeks prior dosing.

- Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.

- Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory)
or with history of myositis, rhabdomyolysis or other myopathic disease.

- Patients receiving immunosuppressive treatment as well as corticosteroids which
cannot be discontinued at least 4 weeks before dosing.

- Patients engaged in a resistance exercise training program.

- Patients with pacemakers or any metallic objects as exclusion for MRI

- Patients with concomitant disease know to get influence on bone metabolism

- Patients who have history of drug or alcohol abuse within 12 months prior study
dosing.

- Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.