UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome

• Sponsor: UCB Celltech (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02610543
• Collaborator: PRA Health Sciences (Industry)
• Enrollment: 27
• Locations: 14
• Arms: 2
• Actual Duration (Months): 26.2
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS).

The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjögren's Syndrome	Drug: UCB5857; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Sep 7, 2017
• Actual Study Completion Date: Dec 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UCB5857 UCB5857 once daily for 12 weeks	Drug: UCB5857; Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral
Placebo Comparator: Placebo Placebo once daily for 12 weeks	Drug: Placebo; Active substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral

Outcome Measures

Primary Outcome Measures

1. Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) [Week 12]

   The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

Secondary Outcome Measures

1. Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) [Week 4]

   The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

2. Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) [Week 8]

   The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

3. Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [Week 4]

   The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

4. Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [Week 8]

   The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

5. Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [Week 12]

   The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

6. Change from Baseline to Week 4 in the stimulated salivary flow [Week 4]

   The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

7. Change from Baseline to Week 8 in the stimulated salivary flow [Week 8]

   The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

8. Change from Baseline to Week 12 in the stimulated salivary flow [Week 12]

   The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

9. Change from Baseline to Week 4 in the unstimulated salivary flow [Week 4]

   The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation

10. Change from Baseline to Week 8 in the unstimulated salivary flow [Week 8]

    The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation.

11. Change from Baseline to Week 12 in the unstimulated salivary flow [Week 12]

    The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation

12. Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia) [Week 12]

    The Schirmer's test measures basic tear function. A 35 mm x 5mm size paper strip is inserted into each eye for a period of 5 minutes to measure the production of tears.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 1 (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 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 (American-European Consensus Group) criteria for Primary Sjӧgren's Syndrome

• Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies

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)

o 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 (HBV) or hepatitis C (HCV)

• 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 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 <10.0 g/dL, or white blood cell (WBC) <2000 /mm^{3, or absolute neutrophil count <1000 /mm}3, or platelets <100,000 /mm^3 at Screening (Visit 1)

• Subject has a history of cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ss0004 34	Brest		France
2	Ss0004 30	Le Kremlin-Bicêtre		France
3	Ss0004 35	Strasbourg		France
4	Ss0004 20	L'Aquila		Italy
5	Ss0004 21	Palermo		Italy
6	Ss0004 22	Udine		Italy
7	Ss0004 42	Cordoba		Spain
8	Ss0004 40	Villajoyosa		Spain
9	Ss0004 50	Stockholm		Sweden
10	Ss0004 01	Birmingham		United Kingdom
11	Ss0004 05	Essex		United Kingdom
12	Ss0004 04	Leeds		United Kingdom
13	Ss0004 03	Newcastle upon Tyne		United Kingdom
14	Ss0004 02	Swindon		United Kingdom

Sponsors and Collaborators

• UCB Celltech
• PRA Health Sciences

Investigators

• Study Director: UCB Cares, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Celltech
• ClinicalTrials.gov Identifier: NCT02610543
• Other Study ID Numbers: SS0004; 2014-004523-51
• First Posted: Nov 20, 2015
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by UCB Celltech: Primary Sjögren's Syndrome
• Additional relevant MeSH terms: Sjogren's Syndrome; Syndrome

Study Results

No Results Posted as of Dec 1, 2020