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

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)

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

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.

Gesamtstatus Recruiting
Anfangsdatum July 12, 2019
Fertigstellungstermin August 18, 2023
Primäres Abschlussdatum July 7, 2023
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change in EULAR Sjögren's syndrome disease activity index (ESSDAI) at week 24 Week 24
Sekundäres Ergebnis
Messen Zeitfenster
Change from baseline in ESSDAI over time Baseline, week 2, week 4, week 8, week 12, week 16 and week 20
Change in EULAR Sjögren's Syndrome Patient Reported intensity (ESSPRI) over time 24 weeks
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) over time 24 weeks
Change from baseline in quality of life as assessed by EQ-5D over time 24 weeks
Change from baseline in quality of life as assessed by PhGA over time 24 weeks
Occurrence of treatment emergent Adverse Events 34 weeks
PK parameters: area under the curve (AUC) 24 weeks
PK parameters: Cmax 24 weeks
PK parameters: Tmax 24 weeks
PK parameters: mean residence time (MRT) 24 weeks
Einschreibung 252
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: LOU064

Beschreibung: 10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules

Interventionsart: Drug

Interventionsname: Placebo

Beschreibung: 0mg hard gelatin capsule

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Gesamtkontakt

Nachname: Novartis Pharmaceuticals

Telefon: 1-888-669-6682

Email: [email protected]

Ort
Einrichtung: Status:
Novartis Investigative Site | Boston, Massachusetts, 02111, United States Recruiting
Novartis Investigative Site | Oklahoma City, Oklahoma, 73104, United States Recruiting
Novartis Investigative Site | Woodville, South Australia, 5011, Australia Recruiting
Novartis Investigative Site | Hobart, Tasmania, 7000, Australia Recruiting
Novartis Investigative Site | Clayton, Victoria, 3168, Australia Recruiting
Novartis Investigative Site | Gent, 9000, Belgium Recruiting
Novartis Investigative Site | Sofia, 1612, Bulgaria Recruiting
Novartis Investigative Site | Hefei, Anhui, 230001, China Recruiting
Novartis Investigative Site | Nanjing, Jiangsu, 210008, China Recruiting
Novartis Investigative Site | Chengdu, Sichuan, 610041, China Recruiting
Novartis Investigative Site | Glostrup, 2600, Denmark Recruiting
Novartis Investigative Site | Berlin, 10117, Germany Recruiting
Novartis Investigative Site | Debrecen, 4032, Hungary Recruiting
Novartis Investigative Site | Sabadell, Barcelona, 08208, Spain Recruiting
Novartis Investigative Site | Valencia, Comunidad Valenciana, 46010, Spain Recruiting
Novartis Investigative Site | Vigo, Pontevedra, 36200, Spain Recruiting
Novartis Investigative Site | Barcelona, 08041, Spain Recruiting
Novartis Investigative Site | Madrid, 28041, Spain Recruiting
Novartis Investigative Site | Basel, 4031, Switzerland Recruiting
Novartis Investigative Site | Lausanne, 1011, Switzerland Recruiting
Novartis Investigative Site | Kaohsiung, 81346, Taiwan Recruiting
Novartis Investigative Site | Taichung, 40447, Taiwan Recruiting
Novartis Investigative Site | Taichung, 40705, Taiwan Recruiting
Novartis Investigative Site | Swindon, SN3 6BB, United Kingdom Recruiting
Standort Länder

Australia

Belgium

Bulgaria

China

Denmark

Germany

Hungary

Spain

Switzerland

Taiwan

United Kingdom

United States

Überprüfungsdatum

July 2020

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 5
Armgruppe

Etikette: LOU064 Dose 1

Art: Experimental

Beschreibung: high orally

Etikette: LOU064 Dose 2

Art: Experimental

Beschreibung: high orally

Etikette: LOU064 Dose 3

Art: Experimental

Beschreibung: middle orally

Etikette: LOU064 Dose 4

Art: Experimental

Beschreibung: low orally

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: 0 mg orally

Akronym LOUiSSe
Patientendaten Undecided
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Other

Maskierung: Triple (Participant, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov