We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

This study is currently recruiting participants.
Verified September 2017 by MedImmune LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02334306
First Posted: January 8, 2015
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by (Responsible Party):
MedImmune LLC
  Purpose
A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

Condition Intervention Phase
Primary Sjögren's Syndrome Biological: AMG 557/MEDI5872 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Change in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) score from Day 1 to Day 99 [ Time Frame: Day 1 to Day 99 ]

Secondary Outcome Measures:
  • Outcomes in peripheral blood - Change in plasma cell (PC) levels (including plasma blast [PB] levels) from baseline to Day 99 [ Time Frame: Day 1 to Day 99 ]
  • Outcomes in minor salivary gland tissue - Change in PC levels from baseline to Day 99 [ Time Frame: Day 1 to Day 99 ]
  • Change in focus score from Day 1 to Day 99 [ Time Frame: Day 1 to Day 99 ]
    Focus score is an assessment of salivary gland inflammation that measures the number of lymphocytes in a 4 mm2 area

  • Safety and tolerability of multiple subcutaneous (SC) doses of AMG 557/MEDI5872 as measured by safety laboratory tests (hematology, chemistry and urinalysis) [ Time Frame: Day 1 to Day 281 ]
  • Change in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Day 1 to Day 99 [ Time Frame: Day 1 to Day 99 ]
  • Outcomes in peripheral blood - Change in follicular helper T cells (TFH) levels from Day 1 to Day 99 [ Time Frame: Day 1 to Day 99 ]
  • Outcomes in minor salivary gland tissue - Change in TFH levels from Day 1 to Day 99 [ Time Frame: Day 1 to Day 99 ]
  • Safety and tolerability of multiple subcutaneous (SC) doses of AMG 557/MEDI5872 as measured by the number of subjects with adverse events, including serious adverse events, treatment-related adverse events and adverse events of special interest [ Time Frame: Day 1 to Day 281 ]

Estimated Enrollment: 42
Actual Study Start Date: June 8, 2015
Estimated Study Completion Date: August 16, 2018
Estimated Primary Completion Date: February 7, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 557/MEDI5872
Fixed subcutaneous (SC) dose of AMG 557/MEDI5872 every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85). Beginning on Day 99, all subjects (n = 42) will receive a fixed SC dose of AMG 557/MEDI5872 every week (Days 99 to 113) and every 2 weeks (Days 127 to 183) for an additional 12 weeks.
Biological: AMG 557/MEDI5872
Fixed subcutaneous (SC) dose of AMG 557/MEDI5872 every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85). Beginning on Day 99, all subjects (n = 42) will receive a fixed SC dose of AMG 557/MEDI5872 every week (Days 99 to 113) and every 2 weeks (Days 127 to 183) for an additional 12 weeks.
Placebo Comparator: Placebo
Fixed SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85). Beginning on Day 99, all subjects (n = 42) will receive a fixed SC dose of AMG 557/MEDI5872 every week (Days 99 to 113) and every 2 weeks (Days 127 to 183) for an additional 12 weeks.
Other: Placebo
Fixed SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85). Beginning on Day 99, all subjects (n = 42) will receive a fixed SC dose of AMG 557/MEDI5872 every week (Days 99 to 113) and every 2 weeks (Days 127 to 183) for an additional 12 weeks.

Detailed Description:
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the clinical and biologic efficacy, as well as the safety of SC doses of AMG 557/MEDI5872 in adult subjects with Primary Sjögren's Syndrome.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 through 75 years at the time of signing the ICF.
  • Fulfill American-European Consensus Group (AECG) criteria for pSS
  • ESSDAI score ≥ 6.
  • Positive anti-SS-A and/or anti-SS-B autoantibodies and at least IgG > 13 g/L or RF level > upper limit of normal (ULN) or positive test for cryoglobulins
  • Willingness to undergo protocol-required minor salivary gland biopsies.
  • Negative TB test during screening
  • Immunization up to date as determined by local standard of care.

Exclusion Criteria:

  • Previous treatment with AMG 557/MEDI5872.
  • Evidence of signs or symptoms of a viral, bacterial, or fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring IV antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
  • Evidence of significant renal insufficiency
  • Positive test at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) antibody.
  • Prior administration of any of the following:

    1. Belimumab in the past 6 months prior to randomization (Day 1);
    2. Rituximab in the past 12 months or CD19+ B cells < 5/µL if rituximab treatment was more than 12 months prior to randomization (Day 1);
    3. Abatacept in the past 6 months prior to randomization (Day 1);
    4. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
    5. Tocilizumab in the past 3 months prior to randomization (Day 1);
    6. Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomization (Day 1); cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3 months prior to randomization (Day 1).
  • Receiving any of the following:

    1. Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
    2. Antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the ICF through randomization (Day 1).
    3. Methotrexate: > 20 mg/week methotrexate; Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1); Any change in route of administration.
    4. Any increase or initiation of new dose of regularly scheduled nonsteroidal anti inflammatory drugs (NSAIDs) within 2 weeks prior to signing the ICF through randomization (Day 1).
    5. Cevimeline or pilocarpine and cyclosporine eye drops (Restasis): any increase or initiation of new doses within 2 weeks prior to signing the ICF through randomization (Day 1).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334306


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
United States, California
Research Site Recruiting
San Francisco, California, United States, 94143
United States, Maryland
Research Site Completed
Bethesda, Maryland, United States, 20892-1190
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
France
Research Site Recruiting
Brest Cedex, France, 29609
Research Site Recruiting
Le Kremlin-bicêtre, France, 94275
Research Site Recruiting
Lille Cedex, France, 59037
Research Site Recruiting
Paris Cedex 13, France, 75651
Research Site Recruiting
Paris, France, 75014
Research Site Recruiting
Strasbourg, France, 67098
Sweden
Research Site Withdrawn
Malmö, Sweden, 21428
Research Site Recruiting
Stockholm, Sweden
United Kingdom
Research Site Recruiting
London, United Kingdom, EC1M 6BQ
Research Site Recruiting
Newcastle-upon-Tyne, United Kingdom, NE2 4HH
Research Site Recruiting
Swindon, United Kingdom, SN3 6BB
Sponsors and Collaborators
MedImmune LLC
Amgen
Investigators
Principal Investigator: Maria Dall'Era, MD University of California, San Francisco
Principal Investigator: Ghaith Noaiseh, MD University of Pittsburgh
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02334306     History of Changes
Other Study ID Numbers: D5181C00001
First Submitted: December 12, 2014
First Posted: January 8, 2015
Last Update Posted: September 15, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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