NCT02141763

Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

A Subject-blind, Investigator-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of UCB4940 in Subjects With Psoriatic Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: UCB Celltech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	UCB4940 40 mg	* 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
DRUG	UCB4940 80 mg	* 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
DRUG	UCB4940 160 mg	* 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
DRUG	UCB4940 240 mg	* 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
DRUG	UCB4940 320 mg	* 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
DRUG	UCB4940 560 mg	* 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
OTHER	Placebo	* Pharmaceutical Form: solution * Concentration: 0.9 % sodium chloride * Route of Administration: intravenous

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-05-19
• Last updated: 2015-09-01

Locations

3 sites across 3 countries: Bulgaria, Moldova, United Kingdom