Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CJM112; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne, inflammatory acne, efficacy, safety, PK

Summary:

      The study was designed primarily to assess preliminary efficacy and safety of CJM112 in
      patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate
      clinical profile for further clinical development. In addition, sustainability of response
      and dose relationship were to be explored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18 to 45 years of age included, 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, inclusive at screening.

          -  Patients with papulo-pustular acne vulgaris with between 25 and 100 facial
             inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory
             lesions (open and closed comedones) in the face at screening and baseline, who have
             failed systemic therapy for inflammatory acne.

          -  No more than 5 facial inflammatory nodules at screening and baseline.

          -  Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on
             the face 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.

          -  Use of facial medium depth chemical peels (excluding home regimens) within 3 months
             prior to baseline.

          -  Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before
             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.

          -  History of hypersensitivity or allergy to the investigational compound/compound class
             being used in this study.

          -  Active systemic infections (other than common cold) during the 2 weeks prior to
             baseline.

          -  History of severe systemic Candida infections or evidence of Candidiasis in the 2
             weeks prior to baseline.

          -  Evidence of active tuberculosis at screening. All patients will be tested for
             tuberculosis status using a blood test (QuantiFERON®-TB (Tuberculosis) Gold In-Tube).
             Patients with evidence of tuberculosis may enter the trial afteradequate treatment has
             been started according to local regulations.

          -  Patients with known active Crohn's disease

          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western
             blot) test result at screening.

          -  A positive Hepatitis B surface antigen or Hepatitis C test result at screening

          -  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.

          -  WOCBP, defined as all women physiologically capable of becoming pregnant, unless they
             are using highly effective methods of contraception during dosing and for 13 weeks
             after stopping medication.

        Other protocol-defined inclusion/exclusion criteria may apply.