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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

Tracking Information
First Submitted Date  ICMJE May 3, 2016
First Posted Date  ICMJE May 23, 2016
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE August 26, 2016
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Anti-drug antibodies [ Time Frame: Day 85 ]
    Presence of anti-drug antibodies (ADA)
  • Pharmacokinetics Cmax [ Time Frame: Day 85 ]
    Maximum concentration of drug achieved
  • Pharmacokinetics Tmax [ Time Frame: Day 85 ]
    Time at which maximum concentration of drug is achieved
  • Pharmacokinetic [ Time Frame: Day 85 ]
    Half Life
  • Pharmacokinetic [ Time Frame: Day 85 ]
    AUC
  • Pharmacodynamics [ Time Frame: Day 85 ]
    Blood levels of plasmacytoid cells.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: May 19, 2016)
Type I Interferon signature [ Time Frame: Day 85 ]
Neutralization ratio of the type I IFN signature
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
Intervention  ICMJE
  • Biological: MEDI7734
    Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
  • Biological: Placebo
    One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Study Arms  ICMJE
  • Active Comparator: MEDI7734
    Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
    Intervention: Biological: MEDI7734
  • Placebo Comparator: Placebo
    One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 27, 2017
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02780674
Other Study ID Numbers  ICMJE D6080C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Viela Bio
Study Sponsor  ICMJE Viela Bio
Collaborators  ICMJE MedImmune LLC
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account Viela Bio
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP