Clinical Trial: Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Subject and Investigator Blinded, Placebo-controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory A

Brief Summary: The study is 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 will be explored.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Total inflammatory facial lesion count at week 12 [ Time Frame: Week 12 ]

Inflammatory facial lesion count


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and tolerability as measured by frequency and severity of adverse events [ Time Frame: Week 38 ]
    Frequency and severity of adverse events
  • Pharmacokinetics (PK): Lowest serum concentration observed during a dosing interval during steady state (Cmin,ss) [ Time Frame: Day 1 to Week 38 ]
    Lowest serum concentration observed during a dosing interval at steady state.
  • Safety and tolerability as measured by hematology laboratory parameters [ Time Frame: Week 38 ]
  • Safety and tolerability as measured by clinical chemistry laboratory parameters [ Time Frame: Week 38 ]
  • Safety and tolerability as measured by urinalysis laboratory parameters [ Time Frame: Week 38 ]


Original Secondary Outcome:

  • Safety and tolerability as measured by frequency and severity of adverse events [ Time Frame: Week 38 ]
    Frequency and severity of adverse events
  • Pharmacokinetics (PK): Lowest serum concentration observed during a dosing interval during steady state (Cmin,ss) [ Time Frame: Day 1 to Week 38 ]
    Lowest serum concentration observed during a dosing interval at steady state.
  • Safety and tolerability as measured by hematology laboratory parameters [ Time Frame: Week 38 ]
  • Pharmacokinetics (PK): Elimination half life of CJM112 (T1/2) [ Time Frame: Day 1 to Week 38 ]
  • Safety and tolerability as measured by clinical chemistry laboratory paramters [ Time Frame: Week 38 ]
  • Safety and tolerability as measured by urinalysis laboratory paratmeters [ Time Frame: Week 38 ]


Information By: Novartis

Dates:
Date Received: December 13, 2016
Date Started: December 22, 2016
Date Completion: October 26, 2018
Last Updated: April 26, 2017
Last Verified: March 2017