Clinical Trial: Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Dose Relation, Pharmacokinetics and Pharmacodynamics of CJM112 in Moderate

Brief Summary: This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Clinical responder rate [ Time Frame: Week 16 ]

Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and tolerability as measured by frequency of adverse events [ Time Frame: Week 44 ]
    Frequency of adverse events, in particular infections
  • Clinical responder rate [ Time Frame: Days 1 to week 44 ]
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score
  • Pharmacokinetic profile [ Time Frame: Day 1 to Week 44 ]
    Total CJM112 total IL-17A (homodimer) and total IL-17AF (heterodimer) in serum. Cmax (maximum serum concentration following drug administration) Cmax,ss (maximum serum concentration following drug administration at steady state) Cmin,ss Cave,ss Tmax (time to reach the maximum concentration after drug administration) AUCtau (area under the serum concentration-time curve from time zero to the end of the dosing interval tau) AUCtau,ss (area under the serum concentration-time curve from time zero to the end of the dosing interval tau at steady state) CL/F (apparent systemic (or total body) clearance from serum following extravascular administration) T1/2 (terminal elimination half-life) Vz/F (apparent volume of distribution during the terminal elimination phase following extravascular administration)
  • Immunogenicity [ Time Frame: Day 1 to Week 44 ]
    Anti-CJM112 antibodies in serum
  • Safety and tolerability as measured by safety laboratories [ Time Frame: Week 44 ]
    Hematology, clinical chemistry and urinalysis
  • Safety and tolerability as measured by physical exam [ Time Frame: Week 44 ]
    Physical examination
  • Safety and tolerability as measured by vital signs [ Time Frame: Week 44 ]
    Body temperature, blood pressure, pulse rate
  • Safety and tolerability as measured by ECG [ Time Frame: Week 44 ]
    PR interval, QRS duration, heart rate, RR, QT, QTc from a standard 12-lead ECG
  • Pharmacodynamic profile as measured by questionnaires and lesion assements [ Time Frame: Day 1 to Week 44 ]
    Questionnaires to assess the patient reported endpoints such as assessment of efficacy, side effects such as pain, tenderness, quality of life as well as impact on work (Numeric rating scale to assess pain, Brief symptom questionnaire, Patient's global assessment, Patient's treatment satisfaction, Dermatology life quality index, EQ-5D-5L and Work Productivity & Activity Impairment Questionnaire:Specific Health Problem) HS assessment, meausred by HS-Physician's Global assessment. Lesion assessment measured by individual lesion count, new individual lesion count, lesion size, HS clinical response (scoring system based on increase/reduction of number of lesions), Modified Sartorius score (scoring system based on atomical region, type of lesion, distance between lesions) and Hurley score (classification of abscess formation and extent)


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 18, 2015
Date Started: April 13, 2015
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017