NCT02141763

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2014

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

May 15, 2014

Last Update Submit

August 31, 2015

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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

    From Baseline to Day 141

  • 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

    From Baseline to Day 141

  • Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study

    From Baseline to Day 141

Study Arms (5)

240/160/160 mg of UCB4940

EXPERIMENTAL

240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)

Drug: UCB4940 160 mgDrug: UCB4940 240 mgOther: Placebo

160/80/80 mg of UCB4940

EXPERIMENTAL

160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)

Drug: UCB4940 80 mgDrug: UCB4940 160 mgOther: Placebo

80/40/40 mg of UCB4940

EXPERIMENTAL

80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)

Drug: UCB4940 40 mgDrug: UCB4940 80 mgOther: Placebo

560/320/320 mg of UCB4940

EXPERIMENTAL

560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)

Drug: UCB4940 320 mgDrug: UCB4940 560 mgOther: Placebo

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial

Drug: UCB4940 40 mgDrug: UCB4940 80 mgDrug: UCB4940 160 mgDrug: UCB4940 240 mgDrug: UCB4940 320 mgDrug: UCB4940 560 mg

Interventions

UCB4940 40 mgDRUG

* 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

80/40/40 mg of UCB4940Placebo
UCB4940 80 mgDRUG

* 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

160/80/80 mg of UCB494080/40/40 mg of UCB4940Placebo
UCB4940 160 mgDRUG

* 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

160/80/80 mg of UCB4940240/160/160 mg of UCB4940Placebo
UCB4940 240 mgDRUG

* 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

240/160/160 mg of UCB4940Placebo
UCB4940 320 mgDRUG

* 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

560/320/320 mg of UCB4940Placebo
UCB4940 560 mgDRUG

* 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

560/320/320 mg of UCB4940Placebo
PlaceboOTHER

* Pharmaceutical Form: solution * Concentration: 0.9 % sodium chloride * Route of Administration: intravenous

160/80/80 mg of UCB4940240/160/160 mg of UCB4940560/320/320 mg of UCB494080/40/40 mg of UCB4940

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of adult-onset psoriatic arthritis made at least 6 months prior to Screening as defined by the Classification Criteria for Psoriatic Arthritis
  • Subject must have active psoriatic lesions or a history of psoriatic skin lesions
  • Subject must have active arthritis
  • Subject has had inadequate response to at least 1 nonbiologic Disease-Modifying Antirheumatic Drug (DMARD) (which may include methotrexate \[MTX\]) and/or 1 approved biologic DMARD
  • Subject must be taking concurrent MTX for at least 3 months at time of Screening, and be on a stable dose at least 4 weeks prior to Baseline
  • Female subject must be postmenopausal (at least 1 year), permanently sterilized or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception during the study period
  • Subject has clinical laboratory test results within the reference ranges of the testing laboratory
  • Subject has Electrocardiogram (ECG) values within the reference ranges of the testing laboratory

You may not qualify if:

  • Subject has absolute neutrophil count \<1.5×109/L, and/or lymphocyte count \<1.0×109/L
  • Subject has known viral hepatitis, has a positive test for hepatitis B surface antigen or is hepatitis C virus antibody positive
  • Subject tests positive to human immunodeficiency virus (HIV)-1/2 antibody
  • Subject has a past medical history or family history of primary immunodeficiency
  • Subject is splenectomized
  • Subject has had a severe infection requiring hospitalization and/or treatment with iv antibiotics in the 6 months before the Screening Visit
  • Subject has a history of positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening
  • Subject has a high risk of acquiring TB infection
  • Subject has a history of alcoholism or drug/chemical abuse
  • Subject has an active infection or has had a serious within 6 weeks before the first dose of Investigational Medicinal Product (IMP)
  • Subject has renal or liver impairment at the Screening Visit
  • Subject has active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ which has been definitively treated with standard of care approaches and is considered cured at Screening)
  • Subject has any other acute or chronic illness which, in the opinion of the Investigator or Study Physician, could pose a threat or harm to the subject
  • Subjects must not have a diagnosis of any other inflammatory arthritis, eg, rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus
  • Subject has a current or past history of gastrointestinal ulceration
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

001

Sofia, Bulgaria

Location

002

Saint Chisinau, Moldova

Location

003

Manchester, United Kingdom

Location

Related Publications (1)

  • Glatt S, Baeten D, Baker T, Griffiths M, Ionescu L, Lawson ADG, Maroof A, Oliver R, Popa S, Strimenopoulou F, Vajjah P, Watling MIL, Yeremenko N, Miossec P, Shaw S. 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. Ann Rheum Dis. 2018 Apr;77(4):523-532. doi: 10.1136/annrheumdis-2017-212127. Epub 2017 Dec 23.

    PMID: 29275332DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

BU(1)MO(1)GB(1)