Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne
Condition: Inflammatory Acne
MeSH terms: Acne Vulgaris
Intervention: LYS006 20 mg; LYS006 2 mg; Placebo
Intervention description: LYS006 20 mg, capsules, oral administration, BID, for 12 weeks; LYS006 2 mg, capsules, oral administration, BID, for 12 weeks; Matching placebo, capsules, oral administration, BID, for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne, efficacy, safety

Summary:

      The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in
      patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate
      clinical profile for further clinical development.
    

Eligibility criteria:

        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 a minimun
             number of 10 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 assessed by the
             investigator at screening and 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 basic methods of
             contraception during dosing of study treatment.