Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)

NCT05001698 | Completed Phase 1

• 1 other identifier: D3468C00002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; SLE; pharmacokinetic; anifrolumab

Outcome Measures

Primary Outcomes (5)

• Time to maximum observed plasma concentration (Tmax) of anifrolumab.

  To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

  Day 1 to Day 141

• Maximum observed plasma concentration (Cmax) of anifrolumab.

  To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

  Day 1 to Day 141

• Area under plasma concentration-time curve over dosing interval (AUC[tau]) of anifrolumab.

  To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

  Day 1 to Day 141

• Pre-dose trough concentration (Ctrough) of anifrolumab.

  To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

  Day 1 to Day 141

• The volume of plasma cleared of drug per unit time (CL) of anifrolumab.

  To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.

  Day 1 to Day 141

Secondary Outcomes (5)

• Incidence of adverse events

  From Screening, Day 1 to Day 141

• Incidence of abnormal vital signs

  From Screening, Day 1 to Day 141

• Incidence of abnormal laboratory parameters

  Day 29, 57, 85, 113, 141

• Anti-drug antibodies (ADA)

  Day 1, 85, 113, 141

• 21-gene Type I interferon PD signature

  Screening, Day 29, 85, 113, 141

Study Arms (1)

Anifrolumab

EXPERIMENTAL

All eligible participants will receive anifrolumab via intravenous (IV) infusion pump.

Biological: Anifrolumab

Interventions

Anifrolumab BIOLOGICAL

intravenous infusion (IV)

Anifrolumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 60 years.
• Body weight ≥ 40 kg.
• Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
• Must be receiving at least one of the following SOC regimens at screening:
• oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for \> 2 weeks;
• Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required;
• Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
• At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
• At screening, SLEDAI-2K score ≥ 6 points.
• Chest imaging shows no clinically significant abnormalities (unless due to SLE).
• No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
• All participants should use effective contraception methods as protocol requests.

You may not qualify if:

• History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
• History or evidence of suicidal ideation or suicidal behavior.
• History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
• History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
• History of immunodeficient condition, HIV positive included.
• Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable.
• History of severe case of herpes zoster.
• Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
• Acute COVID-19 infection or history of severe COVID-19.
• History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
• Women participants with abnormal pap smear results.
• Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor.
• Known history of allergy to any component of the IP formulation or protein related products.
• Receipt of any of the following:
• Intramuscular or IV glucocorticosteroids within 6 weeks;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Nantong, 226001, China

Location

Research Site

Shanghai, 200025, China

Location

Research Site

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 12, 2021
• Study Start: July 27, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (3)