A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02780674
• Date of registration: 03/05/2016
• Prospective Registration: Yes
• Primary sponsor: Viela Bio
• Public title: A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
• Scientific 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
• Date of first enrolment: August 26, 2016
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02780674
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: MedImmune LLC
• Affiliation: MedImmune LLC

Key inclusion & exclusion 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 -



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Intervention(s)

Biological: Placebo

Biological: MEDI7734

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Event [Time Frame: Day 85]

Secondary Outcome(s)

Pharmacokinetics Cmax [Time Frame: Day 85]

Pharmacokinetics Tmax [Time Frame: Day 85]

Anti-drug antibodies [Time Frame: Day 85]

Pharmacodynamics [Time Frame: Day 85]

Pharmacokinetic [Time Frame: Day 85]

Secondary ID(s)

D6080C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MedImmune LLC