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AURORANCT07295847

A Study of AZD0120 in Autoimmune Diseases

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Phase changed: Phase 1 → Phase 1/2 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 22 → 25 locations
    • Interventions modified
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints: 12 to 19
    • Study description shortened, about 60 words
  2. Trial sites expanded: 18 → 22 locationsv6
  3. Site details revised at 1 of 18 sitesv5
  4. Site details revised at 2 of 18 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 10 to 18
    • Start date changed from estimate of Dec 16, 2025 to Jan 9, 2026
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Timeframe: 1 year
Proportion of Participants Achieving a Revised-CRISS Response
Timeframe: Baseline, Week 52
Proportion of participants achieving TIS response and low corticosteroid dose
Timeframe: Baseline, Week 52
Proportion of participants achieving Disease Activity Score 28 C reactive protein (DAS28-CRP) < 2.6
Timeframe: Baseline, Week 12

Secondary (19)

Cellular Kinetics - Cmax
Cellular Kinetics - Tmax
Cellular Kinetics - AUC
Cellular Kinetics - t½λz
Cellular Kinetics - Clast
Show 14 moreShow less
Cellular Kinetics - Tlast
Cellular Kinetics - AUClast
Anti-drug antibodies (ADA) developed against AZD0120 from baseline
Proportion of participants with detectable replication competent lentivirus (RCL) at pre-specified post infusion timepoints.
Change from baseline in the Disease Activity Score (DAS) 28-C-reactive protein (CRP).
Change from baseline in modified Rodnan Skin Score (mRSS).
Change From Baseline in Clinical Measures of Disease Activity
Change From Baseline in Pulmonary Function Parameters
Proportion of Participants Achieving Prespecified Total Improvement Score Thresholds
Change From Baseline in Cutaneous Disease Activity
Proportion of Participants Achieving Prespecified Corticosteroid Use Outcomes
Proportion of Participants Achieving Disease Remission
Proportion of Participants Achieving American College of Rheumatology Response
Change From Baseline in Patient-Reported Outcome Measures

Arms and interventions

AZD0120 Regimen 1Experimental

Participants will receive an infusion of AZD0120 Regimen.

SOC Regimen 1Active comparator

Participants will receive SOC Regimen 1 in RA cohort

SOC Regimen 2Active comparator

Participants will receive SOC regimen 2 in RA cohort

Biologicals: AZD0120

Drugs: SOC

Sites

25 sites in 6 countries

United States 11, Germany 6, Spain 3, Australia 2, United Kingdom 2, Sweden 1