Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141763
• Other study ID #: PA0007
• Secondary ID: 2013-004949-16
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2014
• Last updated: August 31, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyBulgaria: Bulgarian Drug AgencyMoldova: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

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
• 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
• 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
• 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
• 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
• 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

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

Locations

Country	Name	City	State
Bulgaria	001	Sofia
Moldova, Republic of	002	St. Chisinau
United Kingdom	003	Manchester

Sponsors (5)

Lead Sponsor	Collaborator
UCB Celltech	ARENSIA, Moldova, COMAC, Bulgaria, MAC Clinical Research, United Kingdom, Parexel

Countries where clinical trial is conducted

Bulgaria,  Moldova, Republic of,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up 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	No
Primary	Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up 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	No
Primary	Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up 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	No
Primary	Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up 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	No
Primary	Total Clearance (CL) of UCB4940 during the duration of the study (up 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	No
Primary	Volume of distribution (V) of UCB4940 during the duration of the study (up 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	No
Primary	Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study		From Baseline to Day 141	No