NCT02780674

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Interventions

Type	Name	Description
BIOLOGICAL	MEDI7734	Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
BIOLOGICAL	Placebo	One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.

Timeline

• Start date: 2016-08-26
• Primary completion: 2017-10-23
• Completion: 2017-11-27
• First posted: 2016-05-23
• Last updated: 2024-12-13

Locations

7 sites across 1 country: United States