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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02780674
First received: May 3, 2016
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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:
  • Anti-drug antibodies [ Time Frame: Day 85 ]
    Presence of anti-drug antibodies (ADA)

  • Pharmacokinetics [ Time Frame: Day 85 ]
    Cmax

  • Pharmacokinetics [ Time Frame: Day 85 ]
    Tmax

  • Pharmacokinetic [ Time Frame: Day 85 ]
    Half Life

  • Pharmacokinetic [ Time Frame: Day 85 ]
    AUC

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


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


Estimated Enrollment: 36
Actual Study Start Date: August 26, 2016
Estimated Study Completion Date: August 13, 2018
Estimated Primary Completion Date: November 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02780674

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

Locations
United States, Alabama
Research Site Recruiting
Anniston, Alabama, United States, 36207
Research Site Recruiting
Birmingham, Alabama, United States, 35294
United States, Connecticut
Research Site Recruiting
Danbury, Connecticut, United States, 6810
United States, Florida
Research Site Recruiting
DeBary, Florida, United States, 32713
Research Site Recruiting
Jacksonville, Florida, United States, 32216
Research Site Recruiting
Miami Springs, Florida, United States, 33166
United States, Pennsylvania
Research Site Recruiting
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: MedImmune LLC MedImmune LLC
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02780674     History of Changes
Other Study ID Numbers: D6080C00001
Study First Received: May 3, 2016
Last Updated: May 30, 2017
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 MedImmune LLC:
Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc

Additional relevant MeSH terms:
Autoimmune Diseases
Dermatomyositis
Polymyositis
Immune System Diseases
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Interferons
Interferon Type I
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 17, 2017