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

NCT07621809 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CVAY736A22301
• Study Type: interventional
• Target: 570
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sjögren´s Disease

Keywords

Sjögren´s disease; ianalumab; VAY736; high symptom burden; B cell depleting therapy; BAFF receptor; BAFF-R; ESSDAI; ESSPRI; SSSD; monoclonal antibody; dryness; fatigue; autoimmune disease; sicca syndrome; THALASSA

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

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

VAY736 DRUG

VAY736 once monthly solution for injection for subcutaneous use.

Also known as: ianalumab

VAY736 - 300 mg

Placebo DRUG

Placebo once monthly solution for injection for subcutaneous use.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Fatigue; Autoimmune Diseases; Sjogren's Syndrome

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.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 (Estimated): July 15, 2026
• Primary Completion (Estimated): August 14, 2029
• Study Completion (Estimated): August 13, 2033
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share