Primary Sjögren's SyndromePhase 2NCT02610543
UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome
A Phase 2 study testing UCB5857 in people with Primary Sjögren's Syndrome, run by UCB Celltech at 14 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- UCB5857
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Oct 2015to 5 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United Kingdom5 sites
Ss0004 01
Birmingham
Ss0004 05
Essex
Ss0004 04
Leeds
Ss0004 03
Newcastle upon Tyne
Ss0004 02
Swindon
About this study
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
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.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- UCB5857, Placebo
- Keywords
- Primary Sjögren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB5857Drug
Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral
PlaceboDrug
Active substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| UCB5857 | Experimental | UCB5857 once daily for 12 weeks Receives: Drug: UCB5857 |
| Placebo | Placebo comparator | Placebo once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Measured: Week 12
Secondary outcomes (12)
Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Measured: Week 4
Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
Measured: Week 8
Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
Measured: Week 4
Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
Measured: Week 8
Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)
Measured: Week 12
Change from Baseline to Week 4 in the stimulated salivary flow
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
Measured: Week 4
Change from Baseline to Week 8 in the stimulated salivary flow
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
Measured: Week 8
Change from Baseline to Week 12 in the stimulated salivary flow
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
Measured: Week 12
Change from Baseline to Week 4 in the unstimulated salivary flow
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
Measured: Week 4
Change from Baseline to Week 8 in the unstimulated salivary flow
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.
Measured: Week 8
Change from Baseline to Week 12 in the unstimulated salivary flow
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
Measured: Week 12
Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia)
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion7 Sep 2017
- Study completion5 Dec 2017
Why it stopped: Study stopped prematurely due to enrolment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Celltech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +18445992273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610543
- Sponsor's protocol ID
- SS0004
- Other IDs
- 2014-004523-51, 2014
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2015
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Juarez M, Diaz N, Johnston GI, Nayar S, Payne A, Helmer E, Cain D, Williams P, Devauchelle-Pensec V, Fisher BA, Giacomelli R, Gottenberg JE, Guggino G, Kvarnstrom M, Mariette X, Ng WF, Rosas J, Sanchez Burson J, Triolo G, Barone F, Bowman SJ. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjogren's syndrome. Rheumatology (Oxford). 2021 Mar 2;60(3):1364-1375. doi: 10.1093/rheumatology/keaa410.
PubMed 32949140
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02610543
- Acronym / sponsor ID
- SS0004
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped prematurely due to enrolment challenges.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- UCB CelltechIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Oct 2015 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB5857 | Experimental | Drug: UCB5857UCB5857 once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB5857Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral | Drug | UCB5857 |
| PlaceboActive substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral | Drug | Placebo |
Primary outcome
Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Week 12
The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity
12 secondary outcomes
Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Week 4
Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Week 8
Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Time frame: Week 4
Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Time frame: Week 8
Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
Time frame: Week 12
Change from Baseline to Week 4 in the stimulated salivary flow
Time frame: Week 4
Change from Baseline to Week 8 in the stimulated salivary flow
Time frame: Week 8
Change from Baseline to Week 12 in the stimulated salivary flow
Time frame: Week 12
Change from Baseline to Week 4 in the unstimulated salivary flow
Time frame: Week 4
Change from Baseline to Week 8 in the unstimulated salivary flow
Time frame: Week 8
Change from Baseline to Week 12 in the unstimulated salivary flow
Time frame: Week 12
Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia)
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Study stopped prematurely due to enrolment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Results publication: PubMed 32949140Juarez M, Diaz N, Johnston GI, Nayar S, Payne A, Helmer E, Cain D, Williams P, Devauchelle-Pensec V, Fisher BA, Giacomelli R, Gottenberg JE, Guggino G, Kvarnstrom M, Mariette X, Ng WF, Rosas J, Sanchez Burson J, Triolo G, Barone F, Bowman SJ. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjogren's syndrome. Rheumatology (Oxford). 2021 Mar 2;60(3):1364-1375. doi: 10.1093/rheumatology/keaa410.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+18445992273 (UCB)
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UCB5857 in people with Primary Sjögren's Syndrome, run by UCB Celltech at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, France, Italy, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped prematurely due to enrolment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.