Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

UCB

Status and phase: Completed; Phase 1

Conditions: Psoriatic Arthritis

Treatments: Drug: UCB4940 320 mg; Drug: UCB4940 80 mg; Drug: UCB4940 560 mg; Drug: UCB4940 240 mg; Drug: UCB4940 160 mg; Drug: UCB4940 40 mg; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02141763

PA0007

2013-004949-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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53 participants in 5 patient groups, including a placebo group

240/160/160 mg of UCB4940

Experimental group

Description:

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

Treatment:

Drug: UCB4940 160 mg

Other: Placebo

Drug: UCB4940 240 mg

160/80/80 mg of UCB4940

Experimental group

Description:

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

Treatment:

Drug: UCB4940 160 mg

Other: Placebo

Drug: UCB4940 80 mg

80/40/40 mg of UCB4940

Experimental group

Description:

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

Treatment:

Drug: UCB4940 40 mg

Other: Placebo

Drug: UCB4940 80 mg

560/320/320 mg of UCB4940

Experimental group

Description:

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

Treatment:

Drug: UCB4940 320 mg

Other: Placebo

Drug: UCB4940 560 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: UCB4940 320 mg

Drug: UCB4940 160 mg

Drug: UCB4940 40 mg

Drug: UCB4940 240 mg

Drug: UCB4940 80 mg

Drug: UCB4940 560 mg