Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

August 31, 2015 updated by: UCB Celltech

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subjects must not have a noninflammatory condition (eg, osteoarthritis or a known diagnosis of fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of IMP on the subject's primary diagnosis of Psoriatic Arthritis (PsA)
  • Subject has received a live vaccination within 6 weeks before the Screening Visit or intends to have or will need a live vaccination during the course of the study or for the 3 months following last IMP dosing
  • Subject has had an inadequate response to more than 1 approved biologic Drug-Modifying Antirheumatic Drug (DMARD)
  • Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives whichever is the longer before the first dose of UCB4940

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 240/160/160 mg of UCB4940
240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
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
Other: Placebo
  • Pharmaceutical Form: solution
  • Concentration: 0.9 % sodium chloride
  • Route of Administration: intravenous
Experimental: 160/80/80 mg of UCB4940
160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
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
Other: Placebo
  • Pharmaceutical Form: solution
  • Concentration: 0.9 % sodium chloride
  • 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
Experimental: 80/40/40 mg of UCB4940
80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
Other: Placebo
  • Pharmaceutical Form: solution
  • Concentration: 0.9 % sodium chloride
  • 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 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
Experimental: 560/320/320 mg of UCB4940
560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
Other: Placebo
  • Pharmaceutical Form: solution
  • Concentration: 0.9 % sodium chloride
  • 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
Placebo Comparator: Placebo
0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
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 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 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 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Baseline to Day 141
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
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)
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
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)
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
From Baseline to Day 141
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
From Baseline to Day 141
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
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
From Baseline to Day 141

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Celltech

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel
Comac Medical
MAC Clinical Research
ARENSIA, Moldova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PA0007
  • 2013-004949-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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