A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome

Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome

Sponsoren

Hauptsponsor: Peking University People's Hospital

Mitarbeiter: Monash University
Beijing ShuangLu Pharmaceutical Co., Ltd.

Quelle Peking University People's Hospital
Kurze Zusammenfassung

Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

detaillierte Beschreibung

Each pSS patients (n=60) with Scores>=6 on ESSDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety, clinical and immunologic response.

Gesamtstatus Completed
Anfangsdatum June 1, 2015
Fertigstellungstermin August 31, 2017
Primäres Abschlussdatum March 31, 2017
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome 24 weeks
Sekundäres Ergebnis
Messen Zeitfenster
Immunological Responses 0,12,24weeks
Einschreibung 60
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: hrIL-2 active

Beschreibung: 1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1

Armgruppenetikett: Experimental: hrIL-2 active

Anderer Name: Human recombinant IL-2

Interventionsart: Drug

Interventionsname: hrIL-2 placebo

Beschreibung: 1 million U doses of placebo s.c. injection active group: placebo group =1:1

Armgruppenetikett: Placebo Comparator: hrIL-2 placebo

Anderer Name: placebo

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Diagnosis of a primary Sjögren´s Syndrome

- ESSDAI score ≥ 6

- Liver values above 1,5 ULN

- Stable low dose systemic use of Glucocorticoids(<=7.5mg) in the last 4 weeks before begin with Study medication

Exclusion Criteria:

- Secondary Sjögren's Syndrome

- Pre-treatment with Cyclosporine A

- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives

- Infection

- Neoplasia

- Relevant cardiac, pulmonary, neurologic or psychiatric disease

- Life-Vaccination within 4 weeks before begin with study medication

- Pregnant or breast-feeding

- Weight under 45kg or more than 80kg

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 65 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Zhanguo Li, MD, PhD Principal Investigator Peking University Institute of Rheumatology and Immunology
Ort
Einrichtung: Department of Rheumatology and Immunology, Peking University People's Hospital
Standort Länder

China

Überprüfungsdatum

March 2018

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Peking University People's Hospital

Vollständiger Name des Ermittlers: Zhanguo Li

Ermittlertitel: Chief of Department of Rheumatology and Immunology,Peking University People's Hospital

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Experimental: hrIL-2 active

Art: Active Comparator

Beschreibung: Intervention:Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection

Etikette: Placebo Comparator: hrIL-2 placebo

Art: Placebo Comparator

Beschreibung: 1 million U doses of placebo s.c. injection

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

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

Quelle: ClinicalTrials.gov