Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

NCT ID: NCT02141763

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

240/160/160 mg of UCB4940

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

Group Type: EXPERIMENTAL

UCB4940 160 mg

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

160/80/80 mg of UCB4940

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

Group Type: EXPERIMENTAL

UCB4940 80 mg

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

80/40/40 mg of UCB4940

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

Group Type: EXPERIMENTAL

UCB4940 40 mg

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

560/320/320 mg of UCB4940

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

Group Type: EXPERIMENTAL

UCB4940 320 mg

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

UCB4940 40 mg

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

MAC Clinical Research

OTHER

Sponsor Role: collaborator

Comac Medical

INDUSTRY

Sponsor Role: collaborator

ARENSIA, Moldova

UNKNOWN

Sponsor Role: collaborator

UCB Celltech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

001

Sofia, , Bulgaria

002

Saint Chisinau, , Moldova

003

Manchester, , United Kingdom

Countries

Bulgaria; Moldova; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29275332 (View on PubMed)

Other Identifiers

2013-004949-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PA0007

Identifier Type: -

Identifier Source: org_study_id