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Trial record 1 of 2 for:    MEDI7734
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A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02780674
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Viela Bio (acquired by Horizon Therapeutics) ( Viela Bio )

Study Description
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Brief Summary:
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.

Condition or disease Intervention/treatment Phase
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc Biological: MEDI7734 Biological: Placebo Phase 1

Detailed Description:

MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo.

The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis.

After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
 Biological: MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Placebo Comparator: Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
 Biological: Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Event [ Time Frame: Day 85 ]
    The safety and tolerability of MEDI7734 as measured by the incidence of any adverse events that occur on or after the day of administration of investigational product through the end of follow-up. Laboratory measurements, vital sign measurements, and electrocardiogram (ECG) parameters will also be evaluated as part of safety.


Secondary Outcome Measures :
  1. Anti-drug antibodies [ Time Frame: Day 85 ]
    Presence of anti-drug antibodies (ADA)

  2. Pharmacokinetics Cmax [ Time Frame: Day 85 ]
    Maximum concentration of drug achieved

  3. Pharmacokinetics Tmax [ Time Frame: Day 85 ]
    Time at which maximum concentration of drug is achieved

  4. Pharmacokinetic [ Time Frame: Day 85 ]
    Half Life

  5. Pharmacokinetic [ Time Frame: Day 85 ]
    AUC

  6. Pharmacodynamics [ Time Frame: Day 85 ]
    Blood levels of plasmacytoid cells.


Other Outcome Measures:
  1. Type I Interferon signature [ Time Frame: Day 85 ]
    Neutralization ratio of the type I IFN signature


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

Key Inclusion Criteria:

  1. Age 18-65 years old
  2. Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
  3. Weight 40-120kg
  4. Stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months.

Key Exclusion Criteria:

  1. History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
  2. Chronic hepatitis B, chronic hepatitis C, or HIV infection.
  3. History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
  4. Herpes zoster infection within 3 months before randomization
  5. Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
  6. Receipt of a mAb within 5 published half-lives prior to Day 1.
  7. Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
  8. Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
  9. Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
Contacts and Locations
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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): NCT02780674


Locations
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United States, Alabama
Research Site
Anniston, Alabama, United States, 36207
Research Site
Birmingham, Alabama, United States, 35294
United States, Connecticut
Research Site
Danbury, Connecticut, United States, 6810
United States, Florida
Research Site
DeBary, Florida, United States, 32713
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Miami Springs, Florida, United States, 33166
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Viela Bio
MedImmune LLC
Investigators
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Study Director: MedImmune LLC MedImmune LLC
More Information
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Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT02780674    
Other Study ID Numbers: D6080C00001
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. Additional information can be found on astrazenecaclinicaltrials.com.
Keywords provided by Viela Bio (acquired by Horizon Therapeutics) ( Viela Bio ):
Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Autoimmune Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Immune System Diseases
 Myositis
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Skin Diseases