? A randomized double-blind placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sj?gren?s Syndrome
Domenick Zero, DDS, MS
Primary Investigator
Overview
The purpose of the current study is 2-fold: (i) to determine the dose-response relationship of ianalumab for key efficacy and safety parameters in order to define the most appropriate dose(s) for subsequent clinical studies (i.e., phase 3), and (ii) to evaluate which clinical endpoint(s) and/or scoring systems best characterize the multidimensional features of pSS.
Description
The purpose of the current study is 2-fold: (i) to determine the dose-response relationship of ianalumab for key efficacy and safety parameters in order to define the most appropriate dose(s) for subsequent clinical studies (i.e., phase 3), and (ii) to evaluate which clinical endpoint(s) and/or scoring systems best characterize the multidimensional features of pSS.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Sjogren's syndrome
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Age: Between 18 Years - 75 Years
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Gender: All
Inclusion Criteria
Diagnosed with Sjogren?s Syndrome
Exclusion Criteria
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
Secondary Sj?gren?s syndrome (presence of another connective tissue disease)
Prior use of any B-cell depleting therapy
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-? mAb; intravenous/subcutaneous 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
History of major organ, hematopoietic stem cell or bone marrow transplant
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug (sucrose, L-Arginine hydrochloride, L-histidine, polysorbate 80, hydrochloric acid)
Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect
Receipt of live/attenuated vaccine within a 2 month period before baseline
History of primary or secondary immunodeficiency, including a positive HIV (ELISA and Western blot) test result
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin, in situ cervical cancer or pSS related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
History of sarcoidosis
Positive hepatitis B surface antigen (HBsAg), antiHB core antigen (anti-HBc) or anti-HB surface antigen (anti-HBs) or positive hepatitis C test result
Evidence of active tuberculosis (TB) infection
Pregnant or nursing (lactating) women
