Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: Anifrolumab

• Registration Number: NCT05001698
• Lead Sponsor: AstraZeneca

Brief Summary

To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).

Detailed Description

This is a Phase I, open-label, single-arm, multiple-dose study to evaluate the pharmacokinetics (PK), pharmacodynamics(PD), safety and tolerability profile of intravenously administered anifrolumab in Chinese participants with active SLE despite receiving standard of care (SOC).

Study Timeline

• Study First Submitted: 2021-06-30
• Study Start: 2021-07-27
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anifrolumab	Anifrolumab	All eligible participants will receive anifrolumab via intravenous (IV) infusion pump.

Primary Outcome Measures

Name	Time	Method
Time to maximum observed plasma concentration (Tmax) of anifrolumab.	Day 1 to Day 141	To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Maximum observed plasma concentration (Cmax) of anifrolumab.	Day 1 to Day 141	To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
The volume of plasma cleared of drug per unit time (CL) of anifrolumab.	Day 1 to Day 141	To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Pre-dose trough concentration (Ctrough) of anifrolumab.	Day 1 to Day 141	To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of anifrolumab.	Day 1 to Day 141	To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	From Screening, Day 1 to Day 141	To characterise the safety and tolerability of anifrolumab via IV infusion.
21-gene Type I interferon PD signature	Screening, Day 29, 85, 113, 141	To evaluate the IFN level change from baseline after administration of anifrolumab.
Anti-drug antibodies (ADA)	Day 1, 85, 113, 141	To characterise the immunogenicity of anifrolumab via IV infusion.
Incidence of abnormal vital signs	From Screening, Day 1 to Day 141	To characterise the safety and tolerability of anifrolumab via IV infusion.
Incidence of abnormal laboratory parameters	Day 29, 57, 85, 113, 141	To characterise the safety and tolerability of anifrolumab via IV infusion.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China