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

• ClinicalTrials.gov Identifier: NCT02464319
• Recruitment Status: Completed
• First Posted: June 8, 2015
• Last Update Posted: March 15, 2018
• Sponsor: Peking University People's Hospital
• Collaborators: Monash University; Beijing ShuangLu Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Zhanguo Li, Peking University People's Hospital

Study Description

Brief Summary:

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)).

Condition or disease	Intervention/treatment	Phase
Primary Sjögren's Syndrome	Drug: hrIL-2 active; Drug: hrIL-2 placebo	Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
• Actual Study Start Date: June 1, 2015
• Actual Primary Completion Date: March 31, 2017
• Actual Study Completion Date: August 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Experimental: hrIL-2 active; 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	Drug: hrIL-2 active; 1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1; Other Name: Human recombinant IL-2
Placebo Comparator: Placebo Comparator: hrIL-2 placebo; 1 million U doses of placebo s.c. injection	Drug: hrIL-2 placebo; 1 million U doses of placebo s.c. injection active group: placebo group =1:1; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

1. Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Immunological Responses [ Time Frame: 0,12,24weeks ]
   Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Beijing

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

Beijing, Beijing, China, 100044

Sponsors and Collaborators

Peking University People's Hospital

Monash University

Beijing ShuangLu Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Zhanguo Li, MD, PhD; Peking University Institute of Rheumatology and Immunology

More Information

• Responsible Party: Zhanguo Li, Chief of Department of Rheumatology and Immunology,Peking University People's Hospital, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT02464319
• Other Study ID Numbers: hrIL-2-SS1
• First Posted: June 8, 2015
• Last Update Posted: March 15, 2018
• Last Verified: March 2018

Additional relevant MeSH terms:

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