UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2014-004523-51-GB
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: UCB Celltech, UK
• Public title: UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME
• Date of first enrolment: 18/05/2015
• Target sample size: 58
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004523-51
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, Greece, Italy, Spain, Sweden, United Kingdom

Contacts

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
•Subject must be between 18 years and 75 years of age
•Women of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth control must be of non-childbearing potential defined as: permanently sterile, congenitally sterile or postmenopausal for at least 2 years prior to Screening (Visit 1). Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be negative by urine testing prior to the first dose of study drug at Week 0 (Visit 2).
Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the last dose of the study drug. In addition female partner of childbearing potential of male subject must be willing to use a highly effective method of contraception for duration of study and for 3 months after last dose of study drug.
•Subject must meet the 2002 AECG criteria for Primary Sjogren’s Syndrome
•Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion criteria:
•Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren’s syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus)
•Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease)
•Subject has, significant fibromyalgia syndrome as defined by the American College of Rheumatology 2010 classification criteria.
•Subject has, significant depression as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders.
•Subject has oral candidiasis
•Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP)
•Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
*Positive testing for HIV-1/2 at screening (Visit 1)
•Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B or C or tuberculosis (TB).
*Positive testing for HBV at Screening (Visit 1)
*Positive testing for HCV at Screening (Visit 1)
•A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigator’s clinical judgment is also excluded. Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes
•Subject is, in the opinion of the Investigator, at a particularly high risk of significant infection due to their lifestyle and/or occupation
•Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
•Subject has significant hematologic abnormalities of hemoglobin <8.0g/dL, or white blood cell (WBC) <2000/mm3, or absolute neutrophil count <1000/mm3, or platelets <30,000/mm3 at Screening (Visit 1)
•Subject has a history of cancer


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary Sjogren’s Syndrome
MedDRA version: 19.1 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Main Objective: The primary objective of the study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with Primary Sjogren’s Syndrome.

Primary end point(s): Change from Baseline in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI)

Secondary Objective: 1) The efficacy of UCB5857 on changes:
- in salivary function
- in tear function
- patient reported outcomes
- cost effectiveness
2)PK profile of UCB5857 in subjects with pSS

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Week 4, 8 and 12
2) Week 4, 8 and 12
3) Week 4, 8 and 12
4) Week 12

Secondary end point(s): 1) Change from Baseline in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
2) Change from Baseline in the stimulated salivary flow
3)Change from Baseline in the unstimulated salivary flow
4)Change from Baseline in Schirmer I test (without anesthesia)

Secondary ID(s)

SS0004

Source(s) of Monetary Support

UCB Celltech, UK