Back to resultsA Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Primary Purpose
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI7734
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc focused on measuring Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
Eligibility Criteria
Key Inclusion Criteria:
- Age 18-65 years old
- Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
- Weight 40-120kg
- 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:
- History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
- Chronic hepatitis B, chronic hepatitis C, or HIV infection.
- History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
- Herpes zoster infection within 3 months before randomization
- Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
- Receipt of a mAb within 5 published half-lives prior to Day 1.
- Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
- Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
- Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MEDI7734
Placebo
Arm Description
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Event
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
Presence of anti-drug antibodies (ADA)
Pharmacokinetics Cmax
Maximum concentration of drug achieved
Pharmacokinetics Tmax
Time at which maximum concentration of drug is achieved
Pharmacokinetic
Half Life
Pharmacokinetic
AUC
Pharmacodynamics
Blood levels of plasmacytoid cells.
Full Information
NCT ID
NCT02780674
First Posted
May 3, 2016
Last Updated
December 19, 2018
Sponsor
Viela Bio
Collaborators
MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT02780674
Brief Title
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 26, 2016 (Actual)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio
Collaborators
MedImmune LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
Keywords
Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI7734
Arm Type
Active Comparator
Arm Description
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Intervention Type
Biological
Intervention Name(s)
MEDI7734
Intervention Description
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Event
Description
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.
Time Frame
Day 85
Secondary Outcome Measure Information:
Title
Anti-drug antibodies
Description
Presence of anti-drug antibodies (ADA)
Time Frame
Day 85
Title
Pharmacokinetics Cmax
Description
Maximum concentration of drug achieved
Time Frame
Day 85
Title
Pharmacokinetics Tmax
Description
Time at which maximum concentration of drug is achieved
Time Frame
Day 85
Title
Pharmacokinetic
Description
Half Life
Time Frame
Day 85
Title
Pharmacokinetic
Description
AUC
Time Frame
Day 85
Title
Pharmacodynamics
Description
Blood levels of plasmacytoid cells.
Time Frame
Day 85
Other Pre-specified Outcome Measures:
Title
Type I Interferon signature
Description
Neutralization ratio of the type I IFN signature
Time Frame
Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age 18-65 years old
Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
Weight 40-120kg
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:
History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
Chronic hepatitis B, chronic hepatitis C, or HIV infection.
History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
Herpes zoster infection within 3 months before randomization
Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
Receipt of a mAb within 5 published half-lives prior to Day 1.
Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MedImmune LLC
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
6810
Country
United States
Facility Name
Research Site
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
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