Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome

A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

detaillierte Beschreibung

This is a double-blind, randomized, placebo-controlled, multicenter study of CFZ533 in 2 distinct populations (cohorts) of patients with Sjögren's Syndrome: 1) moderate-to-severe disease (systemic and symptomatic involvement) and; 2) low systemic involvement but high symptom burden.

The study includes up to 6 weeks screning period, 48 weeks of treatment (divided into treatment periods of 24 weeks each) and 12 weeks follow up. Study treament will be administered as bi-weekly subcutaneous injections.

Gesamtstatus Recruiting
Anfangsdatum October 1, 2019
Fertigstellungstermin June 21, 2022
Primäres Abschlussdatum October 12, 2021
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo 24 weeks
Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score from baseline at 24 weeks as compared to placebo. 24 weeks
Sekundäres Ergebnis
Messen Zeitfenster
Change from baseline in ESSPRI at Week 24 24 weeks
Change from baseline in score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire at Week 24 24 weeks
Change from baseline in Physician Global Assessment (PhGA) at Week 24 24 weeks
Change from baseline in ESSDAI at Week 24 24 weeks
Proportion of subjects with at least 12 points improvement measured by score of Impact of Dry Eye on Everyday Life (IDEEL) questionnaire symptom bother module at Week 24. 24 weeks
Incidence of adverse events (AEs), serious adverse events (SAEs) from baseline to Week 24 and from week 24 to the end of study 60 weeks
Serum Free Light Chain (FLC) levels at analysis visit up to end of study 60 weeks
Immunoglobulin IgG and IgM levels at analysis visits up to end of study 60 weeks
Percent change from baseline in plasma CXCL-13 levels at analysis visits up to end of study 60 weeks
Einschreibung 260
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: CFZ533

Beschreibung: Biological

Anderer Name: iscalimab

Interventionsart: Other

Interventionsname: Placebo

Beschreibung: liquid placebo for injections

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Signed informed consent

- Male or female patient ≥ 18 years of age

- Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)

- Seropositive for anti-Ro/SSA antibodies

- Stimulated whole salivary flow rate of ≥ 0.1 mL/min

Inclusion criteria specific for Cohort 1:

- ESSDAI ≥ 5 within the 8 predefined organ domains

- ESSPRI score of ≥5

Inclusion criteria specific for Cohort 2:

- ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1

- ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5

Exclusion Criteria:

- Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness

- Use of other investigational drugs

- Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowe be the protocol.

- Use of steroids at dose >10 mg/day.

- Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2)

- Active viral, bacterial or other infections requiring systemic treatment

- Receipt of live/attenuated vaccine within a 2-month period prior to randomization.

- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).

- Evidence of active tuberculosis (TB) infection.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

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

Nachname: Novartis Pharmaceuticals

Telefon: 1-888-669-6682

Email: [email protected]

Ort
Einrichtung: Status:
Novartis Investigative Site | Duluth, Georgia, 30096, United States Recruiting
Novartis Investigative Site | Nedlands, Western Australia, 6009, Australia Recruiting
Novartis Investigative Site | Graz, 8036, Austria Recruiting
Novartis Investigative Site | Wien, 1090, Austria Recruiting
Novartis Investigative Site | Vitoria, ES, 29055 450, Brazil Recruiting
Novartis Investigative Site | Curitiba, PR, 80440-080, Brazil Recruiting
Novartis Investigative Site | Brest, 29200, France Recruiting
Novartis Investigative Site | Le Kremlin Bicetre, 94275, France Recruiting
Novartis Investigative Site | Lille, 59000, France Recruiting
Novartis Investigative Site | Paris Cedex 14, 75679, France Recruiting
Novartis Investigative Site | Strasbourg, 67000, France Recruiting
Novartis Investigative Site | Dresden, 01307, Germany Recruiting
Novartis Investigative Site | Freiburg, 79106, Germany Recruiting
Novartis Investigative Site | Mainz, 55131, Germany Recruiting
Novartis Investigative Site | Wuerzburg, 97080, Germany Recruiting
Novartis Investigative Site | Athens, 115 27, Greece Recruiting
Novartis Investigative Site | Szekesfehervar, Fejer, 8000, Hungary Recruiting
Novartis Investigative Site | Budapest, 1023, Hungary Recruiting
Novartis Investigative Site | Szeged, 6720, Hungary Recruiting
Novartis Investigative Site | Haifa, 3339419, Israel Recruiting
Novartis Investigative Site | Kfar Saba, 44281, Israel Recruiting
Novartis Investigative Site | Ramat Gan, 52621, Israel Recruiting
Novartis Investigative Site | Milano, MI, 20132, Italy Recruiting
Novartis Investigative Site | Nagoya, Aichi, 457 8510, Japan Recruiting
Novartis Investigative Site | Sasebo-city, Nagasaki, 857-1165, Japan Recruiting
Novartis Investigative Site | Kurashiki, Okayama, 710-8522, Japan Recruiting
Novartis Investigative Site | Chuo ku, Tokyo, 104-8560, Japan Recruiting
Novartis Investigative Site | Shinjuku-ku, Tokyo, 160 8582, Japan Recruiting
Novartis Investigative Site | Gwangju, 61469, Korea, Republic of Recruiting
Novartis Investigative Site | Rotterdam, 3015 CE, Netherlands Recruiting
Novartis Investigative Site | Lisboa, 1050-034, Portugal Recruiting
Novartis Investigative Site | Ponte de Lima, 4990 041, Portugal Recruiting
Novartis Investigative Site | Ekaterinburg, 620028, Russian Federation Recruiting
Novartis Investigative Site | Kazan, 420097, Russian Federation Recruiting
Novartis Investigative Site | Orenburg, 460000, Russian Federation Recruiting
Novartis Investigative Site | St Petersburg, 190068, Russian Federation Recruiting
Novartis Investigative Site | St Petersburg, 195257, Russian Federation Recruiting
Novartis Investigative Site | Ljubljana, SI-1107, Slovenia Recruiting
Novartis Investigative Site | Ankara, 06560, Turkey Recruiting
Novartis Investigative Site | Zuhuratbaba / Istanbul, 34147, Turkey Recruiting
Novartis Investigative Site | Doncaster, DN2 5LT, United Kingdom Recruiting
Standort Länder

Australia

Austria

Brazil

France

Germany

Greece

Hungary

Israel

Italy

Japan

Korea, Republic of

Netherlands

Portugal

Russian Federation

Slovenia

Turkey

United Kingdom

United States

Überprüfungsdatum

August 2020

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 8
Armgruppe

Etikette: Cohort 1 /Arm A

Art: Experimental

Beschreibung: CFZ533 dose 1

Etikette: Cohort 1/Arm B

Art: Experimental

Beschreibung: CFZ533 dose 2

Etikette: Cohort 1/Arm C

Art: Experimental

Beschreibung: CFZ533 dose 3

Etikette: Cohort 1/Arm D

Art: Placebo Comparator

Beschreibung: Placebo dose (up to week 24)

Etikette: Cohort 1/Arm D1

Art: Experimental

Beschreibung: CFZ533 dose 1 (from week 24)

Etikette: Cohort 2/Arm E

Art: Experimental

Beschreibung: CFZ533 dose 1

Etikette: Cohort 2/Arm F

Art: Placebo Comparator

Beschreibung: Placebo dose (up to week 24)

Etikette: Cphort 2/Arm F1

Art: Experimental

Beschreibung: CFZ533 dose 2 (from week 24)

Akronym TWINSS
Patientendaten Undecided
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: Patients will be screened and enrolled into one of the 2 study Cohorts: Cohort 1: At baseline subjects will be randomized in ratio 1:1:1:1 into one of three CFZ533 (iscalimab) arms (A, B or C) or to placebo (Arm D). After completion of 24 weeks of treatment (Period 1) placebo patients (Arm D) will be switched to active treatment (Arm D1) for the subsequent 24 weeks (Period 2). Cohort 2: At baseline subjects will be randomized in ratio 1:1 to iscalimab (Arm E) or to placebo (Arm F). After completion of 24 weeks of treatment (Period 1), placebo patients (Arm F) will be switched to iscalimab active treatment (Arm F1) for the subsequent 24 weeks (Period 2). All patients treated with iscalimab (Arms A,B,C,and E) in Period 1 will continue the same study treatment in Period 2.

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Maskierungsbeschreibung: Patients, investigator staff, persons performing the assessments, will remain blind to the identity of the treatment within each cohort from the time of randomization until end of the study visit (week 60)

Quelle: ClinicalTrials.gov