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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02464319

Collaborator

Monash University (Other), Beijing ShuangLu Pharmaceutical Co., Ltd. (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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

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 :

Jun 1, 2015

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Aug 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 Names: 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 Names: placebo

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 Names:

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 Names:

placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Immunological Responses [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 8, 2015

Last Update Posted:

Mar 15, 2018

Last Verified:

Mar 1, 2018

Additional relevant MeSH terms:

Sjogren's Syndrome

Syndrome

Study Results

No Results Posted as of Mar 15, 2018