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A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)

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ClinicalTrials.gov Identifier: NCT04035668
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor. This study is an adaptive phase 2 study designed to establish safety and efficacy and characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome.

Condition or disease Intervention/treatment Phase
Sjögren Syndrome Drug: LOU064 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: An Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : September 2, 2022
Estimated Study Completion Date : October 14, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LOU064 Dose 1
high orally
Drug: LOU064
10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Experimental: LOU064 Dose 2
high orally
Drug: LOU064
10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Experimental: LOU064 Dose 3
middle orally
Drug: LOU064
10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Experimental: LOU064 Dose 4
low orally
Drug: LOU064
10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Placebo Comparator: Placebo
0 mg orally
Drug: Placebo
0mg hard gelatin capsule




Primary Outcome Measures :
  1. Change in EULAR Sjögren's syndrome disease activity index (ESSDAI) at week 24 [ Time Frame: Week 24 ]
    Efficacy (Clinical Outcome Measures)


Secondary Outcome Measures :
  1. Change from baseline in ESSDAI over time [ Time Frame: Baseline, week 2, week 4, week 8, week 12, week 16 and week 20 ]
    Efficacy (Clinical Outcome Measures)

  2. Change in EULAR Sjögren's Syndrome Patient Reported intensity (ESSPRI) over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)

  3. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)

  4. Change from baseline in quality of life as assessed by EQ-5D over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)

  5. Change from baseline in quality of life as assessed by PhGA over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)

  6. Occurrence of treatment emergent Adverse Events [ Time Frame: 34 weeks ]
    Safety

  7. PK parameters: area under the curve (AUC) [ Time Frame: 24 weeks ]
    Pharmacokinetics

  8. PK parameters: Cmax [ Time Frame: 24 weeks ]
    Pharmacokinetics

  9. PK parameters: Tmax [ Time Frame: 24 weeks ]
    Pharmacokinetics

  10. PK parameters: mean residence time (MRT) [ Time Frame: 24 weeks ]
    Pharmacokinetics



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SjS according to the 2016 ACR/EULAR criteria
  • Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains
  • Screening ESSPRI ≥ 5
  • Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening
  • Unstimulated salivary flow > 0 mL/min.

Exclusion Criteria:

  • Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary illness
  • DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR maintained during study
  • Rituximab or other B cell depleting drug within 12 months of Screening .
  • Current use of prednisone or equivalent > 15mg/d or dose change within 2 weeks prior to Screening
  • Use of medication known to cause, as a major side effect, dry mouth / eyes
  • HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or recurrent infectious disease such as tuberculosis

Other protocol-defined inclusion/exclusion criteria may apply at the end


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035668


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04035668     History of Changes
Other Study ID Numbers: CLOU064E12201
2018-004387-54 ( EudraCT Number )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sjogren Syndrome
Dry Eye Syndromes
Pathological Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases