A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Monoclonal antibody
Monoclonal antibody
Liquid for subcutaneous injection without active drug.
Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Anaheim, California, United States
Number of participants with adverse events as a measure of safety
Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.
Time frame: 19 weeks
Psoriasis Area and Severity Index (PASI)
Time frame: 19 weeks
Total CJM112 Concentrations in Serum
Measurement of drug levels in the blood of treated patients.
Time frame: 19 weeks
Concentration of anti-CJM112 Antibodies in Serum
Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.
Time frame: 19 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Encino, California, United States
Novartis Investigative Site
North Hollywood, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Normal, Illinois, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
...and 8 more locations