BridgeMD
Compares treatment options for Sjögren´s Disease
Official title Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
ClinicalTrials.gov ID: NCT07621809
What this study is testing
What is VAY736?
VAY736 is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for sjögren´s disease.
Also referred to as ianalumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
- Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
- Seropositive for anti-Ro/SSA antibodies at screening
- SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
- Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's...
You likely can't join if
- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
- Systemic sclerosis (SSc)
- Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue...
- Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
- Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
- 36 weeks prior to randomization, or
See the full eligibility criteria
- Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
- Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
- Seropositive for anti-Ro/SSA antibodies at screening
- SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
- Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
- Stimulated whole salivary flow (sSF) rate \> 0.3 mL/min at screening
- Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52...
- Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.
- Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
- Systemic sclerosis (SSc)
- Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment...
- Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
- Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
- 36 weeks prior to randomization, or
- As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
- Prior treatment with ianalumab
- Prior treatment with any of the following within the given period prior to Screening:
- Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.)...
- Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral...
- History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose...
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- League City, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States; League City, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.