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Completed

NCT Number: NCT02141763

Multiple Dose Study 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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

001, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCB4940 40 mg

Drug
  • 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

UCB4940 80 mg

Drug
  • 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

UCB4940 160 mg

Drug
  • 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

UCB4940 240 mg

Drug
  • 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

UCB4940 320 mg

Drug
  • 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

UCB4940 560 mg

Drug
  • 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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

    Time frame: From Baseline to Day 141

Sponsors and collaborators

Lead sponsor

UCB Celltech

Industry

Collaborators

  • ARENSIA, Moldova
  • Comac Medical
  • MAC Clinical Research
  • Parexel

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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