A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
NCT ID: NCT02780674
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2016-08-26
2017-11-27
Brief Summary
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Detailed Description
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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 acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Interventions
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MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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 -
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Danbury, Connecticut, United States
Research Site
DeBary, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami Springs, Florida, United States
Research Site
Duncansville, Pennsylvania, United States
Countries
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Other Identifiers
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D6080C00001
Identifier Type: -
Identifier Source: org_study_id