A study to characterize the Pharmacokinetics, Pharmacodynamics, and Safety of anifrolumab in adult type I Interferon test high Systemic Lupus Erythematosus subject with active skin manifestations

Study identifier:D3461C00008

ClinicalTrials.gov identifier:NCT02962960

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations.

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 2

Healthy volunteers

No

Study drug

Anifrolumab, Placebo

Sex

All

Actual Enrollment

36

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 14 Feb 2017
Primary Completion Date: 22 Jan 2018
Study Completion Date: 17 Dec 2018

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria