To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
* Active Substance: UCB4940 * Pharmaceutical Form: Solution for infusion * Concentration: 80 mg/ml * Route of Administration: Intravenous use
* Active Substance: Placebo * Pharmaceutical Form: Solution for infusion * Concentration: 0.9 % sodium chloride aqueous solution * Route of Administration: Intravenous use
1
Harrow, United Kingdom
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)
Time frame: Baseline to 20 Weeks
Maximum plasma concentration (Cmax)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Time to reach Cmax (Tmax)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Terminal elimination half-life (t1/2)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
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First order terminal elimination rate constant (λz)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Total body clearance (CL)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Volume of distribution in terminal phase (Vz)
Time frame: Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20
Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in thickness of the plaque
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in lesion area
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Week 12
Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)
Time frame: Baseline to Week 12