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Trial record 39 of 357 for:    sjogrens

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035668
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date August 26, 2022
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date November 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
Change in EULAR Sjögren's syndrome disease activity index (ESSDAI) at week 24 [ Time Frame: Week 24 ]
Efficacy (Clinical Outcome Measures)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • 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)
  • Change in EULAR Sjögren's Syndrome Patient Reported intensity (ESSPRI) over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)
  • Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)
  • Change from baseline in quality of life as assessed by EQ-5D over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)
  • Change from baseline in quality of life as assessed by PhGA over time [ Time Frame: 24 weeks ]
    Efficacy (Patient Reported Outcomes)
  • Occurrence of treatment emergent Adverse Events [ Time Frame: 34 weeks ]
    Safety
  • PK parameters: area under the curve (AUC) [ Time Frame: 24 weeks ]
    Pharmacokinetics
  • PK parameters: Cmax [ Time Frame: 24 weeks ]
    Pharmacokinetics
  • PK parameters: Tmax [ Time Frame: 24 weeks ]
    Pharmacokinetics
  • PK parameters: mean residence time (MRT) [ Time Frame: 24 weeks ]
    Pharmacokinetics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Sjögren Syndrome
Intervention  ICMJE
  • Drug: LOU064
    10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules
  • Drug: Placebo
    0mg hard gelatin capsule
Study Arms  ICMJE
  • Experimental: LOU064 Dose 1
    high orally
    Intervention: Drug: LOU064
  • Experimental: LOU064 Dose 2
    high orally
    Intervention: Drug: LOU064
  • Experimental: LOU064 Dose 3
    middle orally
    Intervention: Drug: LOU064
  • Experimental: LOU064 Dose 4
    low orally
    Intervention: Drug: LOU064
  • Placebo Comparator: Placebo
    0 mg orally
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2022)
73
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
252
Actual Study Completion Date  ICMJE November 23, 2021
Actual Primary Completion Date November 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   China,   Denmark,   Germany,   Hungary,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04035668
Other Study ID Numbers  ICMJE CLOU064E12201
2018-004387-54 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP