Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

Phase 1

Completed

Conditions: Psoriatic Arthritis

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

Registration Number: NCT02141763

Lead Sponsor: UCB Celltech

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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 Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
240/160/160 mg of UCB4940	UCB4940 160 mg	240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
240/160/160 mg of UCB4940	UCB4940 240 mg	240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
240/160/160 mg of UCB4940	Placebo	240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
160/80/80 mg of UCB4940	UCB4940 80 mg	160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
160/80/80 mg of UCB4940	UCB4940 160 mg	160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
160/80/80 mg of UCB4940	Placebo	160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
80/40/40 mg of UCB4940	UCB4940 40 mg	80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
80/40/40 mg of UCB4940	UCB4940 80 mg	80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
80/40/40 mg of UCB4940	Placebo	80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
560/320/320 mg of UCB4940	UCB4940 320 mg	560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
560/320/320 mg of UCB4940	UCB4940 560 mg	560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
560/320/320 mg of UCB4940	Placebo	560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses)
Placebo	UCB4940 40 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
Placebo	UCB4940 80 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
Placebo	UCB4940 160 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
Placebo	UCB4940 240 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
Placebo	UCB4940 320 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial
Placebo	UCB4940 560 mg	0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study	From Baseline to Day 141
Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141)	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
Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141)	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
Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141)	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
Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141)	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
Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141)	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
Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141)	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): 002
🇲🇩
St. Chisinau, Moldova, Republic of
001
🇧🇬
Sofia, Bulgaria
003
🇬🇧
Manchester, United Kingdom

Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

Recruitment & Eligibility

Study & Design

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