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Primary Sjögren's SyndromePhase 1/2NCT02495129

Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome

A Phase 1/2 study testing VAY736 lower dose and VAY736 higher dose in people with Primary Sjögren's Syndrome, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary glands of pSS patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Primary Sjögren's Syndrome
What is being tested?
VAY736 lower dose and VAY736 higher dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2015to Sep 2017
Phase
Phase 1/2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Fullfilled consensus criteria for primary Sjögren's syndrome
  • Patients must have elevated serum levels for some Sögren Syndorme specific parameters such as antinuclear antibodies (ANA), rheumatoid factor (RF) etc.
  • healthy male and female people 18-75 years of age

Who cannot join

  • Patients that are suffering from Secondary Sjögren's syndrome.
  • Patients previously treated with monoclonal antibody treatments such as rituximab, infliximab, adalimumab, etc.
  • Part 2
  • Use of other investigational drugs at the time of enrollment
  • Exposure to a sizeable degree of radiation (≥ 5 mSv) in an investigational research study in the past year prior to this study

About this study

Official title: A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT

This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part 3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on Part 3.

The overarching purpose of this study is to test a new drug (VAY736) for the treatment of pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are affected by inflammation. A certain type of white blood cells called B cells prominently infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary glands. Scientific evidence suggests that B cells may be involved in the disease process in pSS and that eliminating B cells may benefit patients with pSS. This study will test a new imaging method and a new treatment for pSS. Both the imaging method and the treatment are specific for B cells.

Being tested
VAY736 lower dose, VAY736 higher dose
Keywords
Primary Sjögren's syndrome, Sicca syndrome, Salivary glands, Positron Emission Tomography, B cell depletion
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VAY736 lower doseDrug

    Patients will receive a total number of 3 monthly subcutaneous injections with the lower dose of VAY736

  • VAY736 higher doseDrug

    Patients will receive a total number of 3 monthly subcutaneous injections with the higher dose of VAY736

Study groups in NCT02495129
Study groupRoleWhat they receive
VAY736 lower doseExperimental12 evaluable patients will be enrolled and randomized (at a ratio of 1:1) to receive either a lower dose or a higher dose of the study drug (VAY736)
Receives: Drug: VAY736 lower dose
VA736 higher doseExperimental12 evaluable patients will be enrolled and randomized (at a ratio of 1:1) to receive either a lower dose or a higher dose of the study drug (VAY736)
Receives: Drug: VAY736 higher dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: To determine the feasibility of measuring major salivary gland infiltrating B cells in pSS patients using [Zr- 89]rituximab PET/CT imaging

    Part 1: PET/CT imaging of pSS major salivary gland 3, 6 and 9 days after i.v. injection with [Zr- 89]rituximab

    Measured: Part 1: 4 weeks

  2. Part 2: To define the normal range of PET/CT imaging values for major salivary gland tissue, cervical lymph nodes and spleen in healthy volunteers with [Zr-89]-rituximab

    Part 2: PET/CT imaging of healthy volunteers' major salivary gland, cervical lymph nodes and spleen on optimal time point after i.v. injection with [Zr-89]-rituximab (e.g. 3 days after injection)

    Measured: Part 2: 4 weeks

  3. Part 3: To compare the effect of two different VAY736 s.c. dose regimes on salivary gland-infiltrating B cells in pSS patients, using [Zr-89]-rituximab PET/CT imaging

    Part 3: PET/CT imaging of pSS tissues on optimal time point after i.v. injection with [Zr-89]-rituximab, at baseline and 12 weeks after the start of VAY736 treatment

    Measured: Part 3: 12 weeks

Secondary outcomes (17)

  1. Safety of multiple s.c. dosing of VAY736 in pSS patients as measured by safety assessments

    AEs, vital signs, ECGs, safety laboratory parameters (Hematology, Biochmistry, Urinalysis)

    Measured: 12 weeks

  2. To asses the pharmacokinetiks of VAY736 in pSS patients

    Multiple s.c. dose VAY736 PK parameter - Area under the curve (AUC)

    Measured: 12 weeks

  3. To assess the pharmacokinetiks of VAY736 in pSS patients

    Multiple s.c. dose VAY736 PK parameter - Trough concentrations after multiple dose

    Measured: 12 weeks

  4. Assess the pharmacodynamic effect of VAY736 on circulating CD19+ B-cells in pSS

    Multiple s.c. dose VAY736 PD parameter - depletion of B cells

    Measured: 12 weeks

  5. Asses effect of two different VAY736 dose levels on target tissue structure and function in pSS

    Assess size of spleen and cervical lyph nodes by PET/CT imaging and ultrasound-aided size measurements

    Measured: 12 weeks

  6. Asses effect of two different VAY736 dose levels on target tissue structure and function in pSS

    Assess salivary glands size and echostructure by ultrasound

    Measured: 12 weeks

  7. Asses effect of two different VAY736 dose levels on target tissue structure and function in pSS

    Assess salivary gland function (quantitative) by salivary flow (stimulated and unstimulated)

    Measured: 12 weeks

  8. Asses effect of two different VAY736 dose levels on target tissue structure and function in pSS

    Assess lacrimal gland function by Schirmer's test

    Measured: 12 weeks

  9. To evaluate the effect of two different VAY736 dose levels (s.c. q4w) on pSS disease activity

    Assess the change in the EULAR Sjögren'sSyndrome Disease Activity Index (ESSDAI).

    Measured: 12 weeks

  10. To evaluate the effect of on self-reported outcomes in pSS patients

    Multidimensional Fatigue Inventory (MFI-20); the short form 36 health Survey (SF-36); EULAR Sjögren's Syndorm Patient Reported Intensity (ESSPRI)

    Measured: 12 weeks

  11. To evaluate the change in the physician global assessment of patients's overall disease activity

    Physician's visual anaglog scale (VAS)

    Measured: 12 weeks

  12. To evaluate the change in the patients global assessment of their disease activity

    Patient's visual analogue scale (VAS)

    Measured: 12 weeks

  13. To assess the immunogenicity of VAY736

    Anti-VAY736 antibodies

    Measured: 12 weeks

  14. To assess the immunogenicity of a micodose of rituximab

    Anti-rituximab antibodies

    Measured: 25 weeks

  15. To asses the pharmacokinetiks of VAY736 in pSS patients

    Multiple s.c. dose VAY736 PK parameter - Cmax

    Measured: 12 weeks

  16. To asses the pharmacokinetiks of VAY736 in pSS patients

    Multiple s.c. dose VAY736 PK parameter - tmax

    Measured: 12 weeks

  17. To asses the pharmacokinetiks of VAY736 in pSS patients

    Multiple s.c. dose VAY736 PK parameter - half live (t1/2)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495129
Sponsor's protocol ID
CVAY736X2103
Status last verified
Feb 2016
First submitted
8 Jul 2015
Last updated
20 Apr 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VAY736 lower dose and VAY736 higher dose in people with Primary Sjögren's Syndrome, run by Novartis Pharmaceuticals.

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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 withdrawn before enrolling participants, so there are no results.

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?

Part 1: To determine the feasibility of measuring major salivary gland infiltrating B cells in pSS patients using [Zr- 89]rituximab PET/CT imaging (time frame: Part 1: 4 weeks). The study lists 3 primary outcomes in all. 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 NCT02495129.

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 20 Apr 2017.

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