A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
001
Sofia, Bulgaria
002
Saint Chisinau, Moldova
003
Manchester, United Kingdom
Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
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* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous
* Pharmaceutical Form: solution * Concentration: 0.9 % sodium chloride * Route of Administration: intravenous
Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141)
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time frame: From Baseline to Day 141
Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study
Time frame: From Baseline to Day 141