Clinical Trials List
2019-09-01 - 2022-12-17
Phase II
Not yet recruiting2
Recruiting3
ICD-10M35.00
Sicca syndrome, unspecified
ICD-10M35.01
Sicca syndrome with keratoconjunctivitis
ICD-10M35.09
Sicca syndrome with other organ involvement
ICD-9710.2
Sicca syndrome
An adaptive Phase 2 randomized, double-blind, placebo-controlled multicenter study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chen Der-Yuan 未分科
- Po-Hao Huang 未分科
- 黃建中 未分科
- 張詩欣 未分科
The Actual Total Number of Participants Enrolled
2 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary objective is to characterize the dose-response relationshipof LOU064 based on change from baseline in ESSDAI at Week 24.
Secondary Objectives
Objective 1: To evaluate the dose-response profile of LOU064 based on change from baseline in ESSPRI at Week 24.
Objective 2: To evaluate the efficacy of LOU064 compared to placebo with respect to change from baseline on patient and physician-reported outcomes (ESSPRI, FACIT-F, EQ-5D, PhGA) over time.
Objective 3:To evaluate the efficacy of LOU064 compared to placebo with
respect to change from baseline in ESSDAI over time.
Objective 4: To evaluate the safety and tolerability of LOU064 by reporting the occurence of treatment emergent AEs (both serious and non-serious), abnormal vital signs, laboratory and ECG values during the study.
Objective 5: To assess PK parameters of LOU064 (Cmax, AUC, Tmax and MRT and others as needed) at steady state.
Inclution Criteria
Classification of Sjögren's Syndrome according to the 2016
ACR/EULAR criteria at screening
Screening ESSDAI (based on weighted score) ≥ 5 from 8 defined
domains (biologic, hematologic, articular, cutaneous, glandular,
lymphadenopathy, renal, constitutional). Patients with involvement of
one or more of the remaining 4 domains are eligible but scores of
these domains will not contribute to the assessment for eligibility, but
will be part of the overall ESSDAI score for that subject
Screening ESSPRI ≥ 5
Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to
screening
Unstimulated whole salivary flow rate of > 0 mL/min at screening
Exclusion Criteria
autoimmune disease constitutes the primary illness
Rituximab or other B cell depleting drug within 12 months of
Screening. For subjects who received such drug, their B cell count
should be within normal range.
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
Required regular use of medications known to cause, as a major
side effect, dry mouth / eyes, and which have not been on a stable
dose for at least 30 days prior to Screening, or any anticipated
change in the treatment regimen during the course of the study.
Significant bleeding risk or coagulation disorders, including but not
limited to:
History or presence of thrombotic or thromboembolic event, or
increased risk for thrombotic or thromboembolic event
Requirement for anti-platelet or anticoagulant medication (for
example, warfarin, or clopidogrel or Novel Oral Anti-Coagulant -
NOAC) other than acetylsalicylic acid (up to 100 mg/d)
History of gastrointestinal or intracerebral or otherwise severe
prior bleeding events, including in association with use of
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Screening CBC laboratory values as follows:
Hemoglobin levels below 10 g/dL
Total leukocyte count less than 3,000/µL
Platelets less than 100,000/µL
Neutrophil count ≤ 1,500/ µL
The Estimated Number of Participants
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Taiwan
20 participants
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Global
252 participants
