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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Novartis Investigative Site
Culver City, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Total Inflammatory Facial Lesion Count at Day 85
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Time frame: Day 85
Number and Severity of Adverse Events in Period 1
Frequency and severity of adverse events in Period 1
Time frame: Day 1 to Day 85
Number and Severity of Adverse Events in Period 2
Frequency and severity of adverse events in Period 2
Time frame: Day 86 to Day 260
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Time frame: Day 1, Day 29, Day 57 and Day 85
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Time frame: Day 85, Day 113, Day 141 and Day 169
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Time frame: 38 Weeks
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
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Bonn, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Pommelsbrunn, Germany
Novartis Investigative Site
Bergen op Zoom, Netherlands
Novartis Investigative Site
Groningen, Netherlands
Novartis Investigative Site
Leiden, Netherlands
Time frame: 38 Weeks
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Time frame: 38 Weeks