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A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.

ConditionsSystemic Lupus ErythematosusIdiopathic Inflammatory MyopathiesRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAstraZeneca

About this trial

The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA

Study details include:

• The study duration will be a minimum of 180 days in addition to the screening period.

Additional follow-up visits may be required up to 12 months from study start.

• Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1), twice (Part 2a), or three times (Part 2b).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.

Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE

Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.

Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.

Disqualifiers

Active severe SLE-driven renal disease.

History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF.

Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).

Inclusion Body Myositis or cancer associated myositis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD5492

    Drug

    IMP: subcutaneous.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Part 1: Single Ascending Dose with AZD5492Experimental treatment 1 intervention
Group B: Part 2: Step-Up Dosing with AZD5492Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events.

Number and percentage of participants with AEs, AESIs, and SAEs

Time frame
Day 1 to end of the study (up to 52 weeks)
2

Safety evaluation of AZD5492: Number of participants with related treatment-emergent adverse events.

Number and percentage of participants with AEs related to IMP as assessed by the investigator

Time frame
Day 1 to end of the study (up to 52 weeks)
3

Safety evaluation of AZD5492: Frequency of dose limiting toxicities (DLTs).

Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol.

Time frame
Day 1 to end of the study (up to 52 weeks)
4

Safety evaluation of AZD5492: Number of SAEs leading to death

Number and percentage of participants with SAEs leading to death.

Time frame
Day 1 to end of the study (up to 52 weeks)

Secondary outcomes

1

Serum Pharmacokinetics (PK) parameters of AZD5492 (Cmax)

Maximum observed serum drug concentration (Cmax) (μg/mL)

Time frame
From Day 1 through Day 60
2

Serum Pharmacokinetics (PK) parameters of AZD5492 (AUC)

Area under the serum concentration-time curve (AUC) (μg/mL\*h)

Time frame
From Day 1 through Day 60
3

Serum Pharmacokinetics (PK) parameters of AZD5492 (t1/2λz)

Terminal elimination half-life (t1/2λz) (In hours)

Time frame
From Day 1 through Day 60
4

Serum Pharmacokinetics (PK) parameters of AZD5492 (AUClast)

Area under the serum concentration time curve from time zero to the time of last quantifiable analyte concentration (AUClast) (nmol\*h/L)

Time frame
From Day 1 through Day 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Fortrea

Collaborator

Source ClinicalTrials.gov
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