A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is

Phase 1

• Conditions: Sjögren's syndrome; MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005055-20-FR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
Historical labial minor salivary gland biopsy showing a focus score =1 Seropositive at screening for anti-Ro/SSA antibodies
Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score = 5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presence of another autoimmune rheumatic disease that is active and constitutes the principle illness, specifically:
- Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSPRI or ESSDAI
- Active rheumatoid arthritis (RA) that impedes on the ability to
score ESSPRI or ESSDAI
Systemic sclerosis
- Any other concurrent connective tissue disease (e.g., 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 syndrome assessment ESSPRI or ESSDAI.
Prior use of ianalumab
- Prior use of any B cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb within 1 year prior to dosing
- B cell count <50 cells/µL
- 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-a 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. Patients who are taking the above mentioned drugs can be included if dose is within the mentioned limits and maintained at stable dose throughout the study
- Active viral, bacterial or other infections that may require systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
- Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect
- For patients undergoing contrast ultrasound: known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound contrast agent
- History of head and neck radiation therapy or of having received
radioactive iodine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate changes in salivary gland histology after treatment with ianalumab;Secondary Objective: To evaluate the safety and tolerability of ianalumab<br>To characterize changes in salivary gland tissue by multimodal salivary gland ultrasound after treatment with ianalumab<br>To assess the pharmacokinetics of ianalumab<br>To assess the immunogenicity of ianalumab<br>To investigate changes in salivary flow rate after treatment with ialanumab;Primary end point(s): Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25<br>(EOT);Timepoint(s) of evaluation of this end point: Week 25

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data over the study period.<br>2. Change from baseline in SGUS parameters over the study period<br>3. Serum ianalumab concentrations during treatment and follow up. PK parameters AUClast, AUCinf, Cmax, Tmax, T1/2 and any other parameters as required<br>4. Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive<br>patients over the study period.<br>5. Change from baseline in mean stimulated and unstimulated salivary flow rate changes over the study period.;Timepoint(s) of evaluation of this end point: 1. Over the study period<br>2. Over the study period<br>3. During treatment and follow-up<br>4. Over the study period<br>5. Over the study period