NCT02141763

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

Completed Phase 1 Last updated 31 August 2015

What this trial tests

Phase 1 trial testing UCB4940 40 mg in Psoriatic Arthritis in 53 participants. Completed in 1 August 2015.

Timeline

1 May 2014

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	UCB Celltech
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	53
Start date	1 May 2014
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	3 locations across Bulgaria, Moldova, United Kingdom

Drugs / interventions tested

• UCB4940 40 mg — full drug profile →
• UCB4940 80 mg — full drug profile →
• UCB4940 160 mg
• UCB4940 240 mg — full drug profile →
• UCB4940 320 mg — full drug profile →
• UCB4940 560 mg — full drug profile →
• Placebo

Conditions studied

• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

UCB Celltech — full company profile →

Who can join

18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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
• Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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
• Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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 to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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
• Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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
• Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141)
  Time frame: From Baseline 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

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation.
   Glatt S, Baeten D, Baker T, Griffiths M, et al · · 2018 · cited 213× · PMID 29275332 · DOI 10.1136/annrheumdis-2017-212127
2. Bimekizumab, a Novel Humanized IgG1 Antibody That Neutralizes Both IL-17A and IL-17F.
   Adams R, Maroof A, Baker T, Lawson ADG, et al · · 2020 · cited 125× · PMID 32973785 · DOI 10.3389/fimmu.2020.01894
3. Dual inhibition of IL-17A and IL-17F in psoriatic disease.
   Iznardo H, Puig L. · · 2021 · cited 29× · PMID 34408825 · DOI 10.1177/20406223211037846
4. Adverse events associated with anti-IL-17 agents for psoriasis and psoriatic arthritis: a systematic scoping review.
   Wang J, Wang C, Liu L, Hong S, et al · · 2023 · cited 25× · PMID 36817423 · DOI 10.3389/fimmu.2023.993057
5. An Overview of Bimekizumab for the Treatment of Psoriatic Arthritis: The Evidence so Far.
   Oliveira DG, Faria R, Torres T. · · 2021 · cited 11× · PMID 33727793 · DOI 10.2147/dddt.s267405
6. Emerging Targets in Psoriatic Arthritis: Dual IL-17A/F and Selective TYK2 Inhibition in a Clinical Perspective.
   Dimopoulou V, Nitsa M, Koutsianas C. · · 2026 · PMID 41648065 · DOI 10.31138/mjr.101025.erh