Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS).

Phase 1

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

• Registration Number: EUCTR2016-003292-22-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Male and female patients aged 18 to 75 years
- Fulfilled revised American European Consensus Group criteria for pSS
- ESSDAI value =6 at baseline, based on weighted scores of the 7 domains: biologic, hematologic, articular, cutaneous, glandular, lymphadenopathy and constitutional
- ESSPRI value =5 at baseline
- Seropositive at screening for anti-Ro/SSA antibodies
- Stimulated whole salivary flow rate at screening of >0.1 mL/min
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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

- Secondary Sjögren’s syndrome (presence of another connective tissue disease)
- 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
- Prior use of any B-cell depleting therapy (e.g., rituximab or other anti- CD20 mAb, anti-CD22 mAb or anti-CD52 mAb)
a. within 1 year prior to randomization
b. or as long as 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 randomization
- Prior treatment with any of the following within 180 days prior to randomization (anti-BAFF mAb; CTLA4-Fc Ig (abatacept); anti-TNF-a mAb; intravenous/subcutaneous immunoglobulin (Ig);
plasmapheresis; i.v. or oral cyclophosphamide; oral cyclosporine
- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
- Receipt of live/attenuated vaccine within a 2 month period before baseline
- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening

Study & Design

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