NCT07621809

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for phase_3

Timeline
83mo left

Started Jul 2026

Longer than P75 for phase_3

Geographic Reach
6 countries

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Aug 2033

First Submitted

Initial submission to the registry

May 26, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 16, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2029

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2033

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

May 26, 2026

Last Update Submit

September 25, 2026

Conditions

Sjögren´s Disease

Keywords

Sjögren´s diseaseianalumabVAY736high symptom burdenB cell depleting therapyBAFF receptorBAFF-RESSDAIESSPRISSSDmonoclonal antibodydrynessfatigueautoimmune diseasesicca syndromeTHALASSA

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in SSSD oral dryness score

    The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).

    Baseline to Week 52

Secondary Outcomes (9)

  • Change from baseline in SSSD summary score

    Baseline to Week 52

  • Change from baseline in ESSPRI score

    Baseline to Week 52

  • Change from baseline in stimulated whole salivary flow (sSF)

    Baseline to Week 52

  • Change from baseline in Patient's Global Assessment (PaGA) NRS score

    Baseline to Week 52

  • Proportion of participants achieving SSSD response

    Week 52

  • +4 more secondary outcomes

Study Arms (2)

VAY736 - 300 mg

EXPERIMENTAL

VAY736 once monthly solution for injection for subcutaneous use.

Drug: VAY736

Placebo

PLACEBO COMPARATOR

Placebo once monthly solution for injection for subcutaneous use.

Drug: Placebo

Interventions

VAY736DRUG

VAY736 once monthly solution for injection for subcutaneous use.

Also known as: ianalumab
VAY736 - 300 mg
PlaceboDRUG

Placebo once monthly solution for injection for subcutaneous use.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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 weeks of the blinded treatment period.
  • Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.

You may not qualify 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 disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
  • 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:
  • 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.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
  • 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 cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
  • 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, L-histidine hydrochloride/L-histidine, polysorbate 20).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Sun Valley Arthritis Center Ltd

Peoria, Arizona, 85381, United States

RECRUITING

Clinical Res Of W Florida

Clearwater, Florida, 33765, United States

RECRUITING

Clinical Research of West Florida Inc

Tampa, Florida, 33606, United States

RECRUITING

Willow Rheumatology Wellness

Willowbrook, Illinois, 60527, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Clinical Research Inst of MI

Saint Clair Shores, Michigan, 48081, United States

RECRUITING

St Lawrence Health System

Potsdam, New York, 13676, United States

RECRUITING

On Site Clinical Solutions Llc

Charlotte, North Carolina, 28202, United States

RECRUITING

RAO Research LLC

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

Shelby Research LLC

Memphis, Tennessee, 38119, United States

RECRUITING

Novel Research LLC

Bellaire, Texas, 77401, United States

RECRUITING

Arthritis Care of Texas

Corpus Christi, Texas, 78415, United States

RECRUITING

Precision Comprehensive Clinical Research Solutions

Euless, Texas, 76040, United States

RECRUITING

Abigail Neiman MD PA

Houston, Texas, 77024, United States

RECRUITING

Accurate Clinical Research

League City, Texas, 77573, United States

RECRUITING

TEKTON

Leander, Texas, 78641, United States

RECRUITING

Arthritis Northwest PLLC

Spokane, Washington, 99216, United States

RECRUITING

Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

RECRUITING

Novartis Investigative Site

Rimouski, Quebec, G5L 5T1, Canada

RECRUITING

Novartis Investigative Site

Sherbrooke, Quebec, J1E 0N8, Canada

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Nashik, Maharashtra, 422101, India

RECRUITING

Novartis Investigative Site

Belagavi, 590001, India

RECRUITING

Novartis Investigative Site

Gwangju, 61469, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

FatigueAutoimmune DiseasesSjogren's Syndrome

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsImmune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 2, 2026

Study Start

July 16, 2026

Primary Completion (Estimated)

August 14, 2029

Study Completion (Estimated)

August 13, 2033

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

US(18)KR(2)CA(2)AU(1)CN(1)IN(2)