Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc Clinical Trial
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
| Verified date | January 2018 |
| Source | Viela Bio |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | November 27, 2017 |
| Est. primary completion date | October 23, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 - |
| Country | Name | City | State |
|---|---|---|---|
| United States | 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 | Duncansville | Pennsylvania |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Miami Springs | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Viela Bio | MedImmune LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Type I Interferon signature | Neutralization ratio of the type I IFN signature | Day 85 | |
| Primary | 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. | Day 85 | |
| Secondary | Anti-drug antibodies | Presence of anti-drug antibodies (ADA) | Day 85 | |
| Secondary | Pharmacokinetics Cmax | Maximum concentration of drug achieved | Day 85 | |
| Secondary | Pharmacokinetics Tmax | Time at which maximum concentration of drug is achieved | Day 85 | |
| Secondary | Pharmacokinetic | Half Life | Day 85 | |
| Secondary | Pharmacokinetic | AUC | Day 85 | |
| Secondary | Pharmacodynamics | Blood levels of plasmacytoid cells. | Day 85 |