Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

Inclusion criteria:

- Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good
health as determined by medical history, physical examination, vital signs, ECGs and
laboratory tests at screening.

- Body weight between 50 and 120 kg, both inclusive, at screening.

- Patients with papulo-pustular acne vulgaris (inflammatory acne) presenting with 20 to
100 facial inflammatory lesions (papules, pustules and nodules) at baseline, no more
than 2 facial inflammatory nodules or cysts at screening and baseline, and
non-inflammatory facial lesions (open and closed comedones).

- Patients who are candidates for systemic treatment and for whom in the opinion of the
investigator, an appropriate previous treatment with topical anti-acne medication
failed, or was not well tolerated, or is not indicated (e.g., due to large body
surface area affected, e.g., on the back)

- Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score confirmed by central
reading of standardized image capture (Visia® system) by an independent dermatologist
at screening and by the investigator's clinical evaluation at baseline.

Exclusion criteria:

- Appropriate wash out periods are required for investigational drugs, any oral/systemic
treatment for acne, systemic or lesional injected (for acne) corticosteroids or
systemic immunomodulators, any systemic hormonal treatments, previous treatment with
biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne
treatment.

- Previous surgical, physical (such as ThermaClear™), light (including blue or UV light,
photodynamic therapy or laser therapy within 4 weeks prior to baseline

- Use of facial medium depth chemical peels (excluding home regimens) within 3 months
prior to baseline.

- Any other forms of acne

- Any severe, progressive or uncontrolled medical or psychiatric condition or other
factors at randomization that in the judgment of the investigator prevents the patient
from participating in the study.

- Active systemic infections (other than common cold) during the 2 weeks prior to
baseline.

- History of immunodeficiency diseases, including a positive HIV (ELISA and Western
blot) test result at screening.

- Chronic infection with Hepatitis B or Hepatitis C virus.

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive Human chorionic gonadotropin (HCG) laboratory test.

- Sexually active males or women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using highly effective
methods of contraception during dosing and for 2 weeks after stopping medication.

Other protocol-defined inclusion/exclusion criteria may apply.