Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
Conditions
Keywords
Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
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 acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Interventions
BIOLOGICALMEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
BIOLOGICALPlacebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Sponsors
MedImmune LLC
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Event | 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
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibodies | Day 85 | Presence of anti-drug antibodies (ADA) |
| Pharmacokinetics Cmax | Day 85 | Maximum concentration of drug achieved |
| Pharmacokinetic | Day 85 | Half Life |
| Pharmacodynamics | Day 85 | Blood levels of plasmacytoid cells. |
| Pharmacokinetics Tmax | Day 85 | Time at which maximum concentration of drug is achieved |
Other
| Measure | Time frame | Description |
|---|---|---|
| Type I Interferon signature | Day 85 | Neutralization ratio of the type I IFN signature |
Countries
United States
Outcome results
None listed