50 Participants Needed

AZD5492 for Lupus and Myositis

(TITAN Trial)

Recruiting at 27 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca
Must be taking: Immunosuppressive drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, you must be on a stable dose of certain medications like prednisolone, methotrexate, or mycophenolate mofetil for a specific period before joining the study.

What data supports the effectiveness of the drug AZD5492 for treating lupus and myositis?

The research highlights the effectiveness of antimalarials and biologic treatments like belimumab in reducing disease activity and improving outcomes in lupus patients. While AZD5492 is not directly mentioned, these findings suggest that similar treatments can be beneficial for managing lupus.12345

What is the purpose of 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.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 Criteria

This trial is for adults with systemic lupus erythematosus (SLE) or idiopathic inflammatory myopathies (IIM). Participants must be able to attend multiple study visits over a minimum of 180 days, with possible follow-ups up to 12 months. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have been diagnosed with lupus according to the 2019 criteria.
My lupus is active and severe, with a score of 4 or higher.
Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening
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Exclusion Criteria

I have had severe brain or nerve issues due to lupus.
Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: 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. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study; Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type); Inclusion Body Myositis or cancer associated myositis
Infections: Any clinical suspicion or diagnosis of active infection at screening; Opportunistic infection that meets criteria to be an SAE within 3 years; Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections, which are allowed); Any history of infection requiring: Hospitalisation within the previous two months; Treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF; Oral anti-infectives within 2 weeks prior to signing the ICF; History of recurrent infection requiring hospitalisation or IV antibiotics eg 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks; Participants with HIV infection (confirmed by central laboratory at screening); Participants with active EBV or CMV; Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive; Participants with evidence of chronic or active hepatitis C defined as: HCV IgM Ab positive; Detectable HCV RNA; Positive result for HCV IgG Ab is acceptable in the following circumstances: HCV RNA is undetectable >12 weeks after completion of curative antiviral treatment for HCV; HCV RNA is undetectable on two occasions at least 12 weeks apart following resolution of HCV infection if not treated; Participants with positive COVID-19 PCR. For participants with a positive COVID-19 reverse transcription PCR at screening, rescreening will be conducted not earlier than 6 weeks after the positive result. Only one rescreening is allowed; Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection; CNS pathology including but limited to the following: CNS vasculitis, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, stroke, seizure disorder/epilepsy, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases; Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) <3 months prior to signing the ICF. If therapy was administered ≥3 months ago, exclude if absolute B-cell less than the lower limit of normal; Prednisolone (or equivalent) > 20 mg within 2 months of signing the ICF.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks
1 visit (in-person)

Treatment Part 1

Participants receive a single ascending dose of AZD5492

26 weeks
Visits on Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180

Treatment Part 2

Participants receive step-up dosing of AZD5492 with two administrations

26 weeks
Visits on Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 52 weeks
Additional follow-up visits may be required

Treatment Details

Interventions

  • AZD5492
Trial Overview The trial is testing AZD5492, given as a subcutaneous injection, for safety and effectiveness in treating SLE or IIM. Part 1 involves one dose; Part 2 involves two doses. The drug's effects on the body will be monitored through regular visits over six months.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2: Step-Up Dosing with AZD5492Experimental Treatment1 Intervention
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.
Group II: Part 1: Single Ascending Dose with AZD5492Experimental Treatment1 Intervention
Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Fortrea

Industry Sponsor

Trials
22
Recruited
5,800+

Findings from Research

In a study of systemic lupus erythematosus (SLE) patients, the probability of reaching a lupus low disease activity state (LLDAS) within one year was 52% for Caucasians, but only 36% for African Americans and 33% for those with renal involvement, highlighting disparities in treatment outcomes.
Factors such as African American ethnicity, high baseline prednisone use, and renal activity were significant predictors of a longer time to achieve LLDAS, indicating the need for tailored approaches in managing SLE, especially for African American patients.
Time to Lupus Low Disease Activity State in the Hopkins Lupus Cohort: Role of African American Ethnicity.Babaoğlu, H., Li, J., Goldman, D., et al.[2022]
In a real-world study of 501 patients with systemic lupus erythematosus (SLE) receiving belimumab for up to 12 months, 31.1% achieved disease control defined as a SELENA-SLEDAI score of ≤2, indicating significant improvement in disease activity.
Glucocorticoid use was notably reduced from a median of 20 mg/day at baseline to 5 mg/day at 12 months, demonstrating that belimumab treatment can help lower the need for these steroids, although no patients achieved complete remission (SELENA-SLEDAI score of 0) during the study.
Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study.Hunnicutt, JN., Fairburn-Beech, J., Georgiou, ME., et al.[2023]

References

Time to Lupus Low Disease Activity State in the Hopkins Lupus Cohort: Role of African American Ethnicity. [2022]
Real-world electronic health record identifies antimalarial underprescribing in patients with lupus nephritis. [2020]
Management of non-renal non-neurologic persistent lupus activity in real world patients from Argentina. [2020]
Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50. [2019]
Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study. [2023]
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