An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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. 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) or twice (Part 2). * Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

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

• Diagnosis of SLE:

‣ 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.

⁃ Intolerance or inadequate response to ≥ 3 available SOC treatments, used for at least 3 months each, for which at least one must be a biologic SoC or cyclophosphamide.

• Diagnosis of IIM:

‣ Must have probable or definite diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR/ACR classification criteria for adult myositis.

⁃ Positive for ≥ 1 disease-specific autoantibody at screening.

⁃ MMT-8 score of ≤ 142/150 and/or CDASI-A \> 6

⁃ Fulfill at least one of the following criteria of active disease at screening:

• (i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met:

⁃ Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation

⁃ Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation

⁃ Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.

• (e) Intolerance or inadequate response to corticosteroids and ≥2 other SoC treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.

• For participants receiving any of the following therapies at screening:

‣ Oral prednisone (or equivalent): Daily dose ≤ 20 mg/day and must be stable for ≥ 1 week prior to Day 1.

⁃ Immunosuppressive treatment: for ≥ 3 months prior to Day 1 and at a stable dose for ≥ 4 weeks prior to Day 1.

Locations
United States
Alabama
Research Site
RECRUITING
Anniston
Other Locations
Canada
Research Site
NOT_YET_RECRUITING
Hamilton
Research Site
NOT_YET_RECRUITING
Sherbrooke
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Wuhan
France
Research Site
NOT_YET_RECRUITING
Bordeaux
Research Site
NOT_YET_RECRUITING
Montpellier
Research Site
NOT_YET_RECRUITING
Nancy
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Strasbourg
Research Site
RECRUITING
Toulouse
Germany
Research Site
NOT_YET_RECRUITING
Cologne
Research Site
NOT_YET_RECRUITING
Erlangen
Research Site
NOT_YET_RECRUITING
Magdeburg
Japan
Research Site
NOT_YET_RECRUITING
Bunkyō City
Research Site
NOT_YET_RECRUITING
Kita-gun
Research Site
NOT_YET_RECRUITING
Kitakyushu-shi
Research Site
NOT_YET_RECRUITING
Kyoto
Research Site
NOT_YET_RECRUITING
Nagasaki
Netherlands
Research Site
NOT_YET_RECRUITING
Amsterdam
Research Site
WITHDRAWN
Leiden
Spain
Research Site
RECRUITING
Mérida
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Valladolid
United Kingdom
Research Site
RECRUITING
Glasgow
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
Southampton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-06-22
Participants
Target number of participants: 54
Treatments
Experimental: Part 1: Single Ascending Dose with AZD5492
Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1.
Experimental: Part 2: Step-Up Dosing with AZD5492
Participants will receive AZD5492 as SC injection at the priming dose determined in Part 1, on Day 1, and at a target dose, based on the emergent safety data, on Day 8.
Sponsors
Leads: AstraZeneca
Collaborators: Fortrea

This content was sourced from clinicaltrials.gov

Similar Clinical Trials