NCT02464319

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

May 30, 2015

Last Update Submit

March 13, 2018

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

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

    24 weeks

Secondary Outcomes (1)

  • Immunological Responses

    0,12,24weeks

Study Arms (2)

Experimental: hrIL-2 active

ACTIVE COMPARATOR

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

Placebo Comparator: hrIL-2 placebo

PLACEBO COMPARATOR

1 million U doses of placebo s.c. injection

Drug: hrIL-2 placebo

Interventions

hrIL-2 activeDRUG

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

Also known as: Human recombinant IL-2
Experimental: hrIL-2 active
hrIL-2 placeboDRUG

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

Also known as: placebo
Placebo Comparator: hrIL-2 placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (2)

  • Feng R, Xiao X, Wang Y, Huang B, Chen J, Cheng G, Jin Y. Metabolic impact of low dose IL-2 therapy for primary Sjogren's Syndrome in a double-blind, randomized clinical trial. Clin Rheumatol. 2024 Dec;43(12):3789-3798. doi: 10.1007/s10067-024-07165-2. Epub 2024 Oct 31.

    PMID: 39482484DERIVED

  • He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.

    PMID: 36355371DERIVED

Study Officials

  • Zhanguo Li, MD, PhD

    Peking University Institute of Rheumatology and Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Rheumatology and Immunology,Peking University People's Hospital

Study Record Dates

First Submitted

May 30, 2015

First Posted

June 8, 2015

Study Start

June 1, 2015

Primary Completion

March 31, 2017

Study Completion

August 31, 2017

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

CN(1)