Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

NCT05124925 | Completed Phase 2

• 2 other identifiers: CVAY736A21032023-508957-24-00
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Conditions

Sjogren Syndrome

Keywords

Sjogren syndrome; VAY736; Ianalumab; dry eyes; dry mouth

Outcome Measures

Primary Outcomes (1)

• Change in logarithm of salivary gland B/B+T cell ratio

  Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT)

  Week 25

Secondary Outcomes (10)

• Number of participants with Adverse Events

  6 months treatment plus 2 years of follow-up

• Change from baseline in disease activity at salivary gland level by ultrasound imaging

  6 months treatment plus 2 years of follow-up

• Incidence of ADA positive patients

  6 months treatment plus 2 years of follow-up

• Change of salivary flow

  6 months treatment plus 2 years of follow-up

• Serum ianalumab concentrations PK parameters Tmax

  6 months treatment plus 2 years of follow-up

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Ianalumab 300 mg subcutaneous monthly

Biological: Ianalumab

Interventions

Ianalumab BIOLOGICAL

Ianalumab VAY736 150mg/1ml Solution for injection

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed
• Male and female patients 18 years of age or older at Screening
• Confirmed Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria
• Seropositive for anti-Ro/SSA antibodies
• Screening ESSPRI score ≥ 5
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

You may not qualify if:

• Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations
• Presence of another autoimmune rheumatic disease that is active and constitutes the primary illness
• Prior use of ianalumab
• History of receiving:
• o Any B-cell depleting therapies, other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
• Current use of prednisone \>10 mg/day \[or equivalent other corticosteroid\] or dose change within 2 weeks prior to dosing
• Prior treatment with any of the following within 6 months of baseline
• CTLA4-Fc Ig (abatacept)
• Anti-TNF-α mAb
• Intravenous Ig
• Plasmapheresis
• i.v. or oral cyclophosphamide
• i.v. or oral cyclosporine A
• Patients taking either hydroxychloroquine more than 400 mg/day or methotrexate more than 25 mg weekly or leflunomide at not stable dose within 3 months prior to dosing.
• iscalimab (anti-CD40)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Brest, 29200, France

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes; Xerostomia

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label study (with no control arm) with a 5 weeks screening period, a 6-month treatment period and a follow up period of up to 2 years after the last dose The study consists of a first Run-in Phase that includes Screening and Baseline period of 35 days. After signing the Informed Consent, participants will be assessed as per inclusion/exclusion criteria. All study participants who successfully pass the screening will be considered eligible for the treatment period. All eligible participants will enter the 6 months treatment period and will have the two other biopsies taken at the end of treatment (6 months after the screening) and end of the study (EOS) after blood B cell recovery (from 5 months up to 2 years after the last dose).

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: July 27, 2022
• Primary Completion: June 26, 2024
• Study Completion: January 5, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)