AZD5492 for Lupus and Myositis

(TITAN Trial)

Recruiting at 20 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AstraZeneca

No Placebo Group

Trial Summary

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 am between 18 and 65 years old.

I have been diagnosed with lupus according to the 2019 criteria.

My lupus is active and severe, with a score of 4 or higher.

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.

Treatment Details

Interventions

• AZD5492 (Other)

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

Group I: Part 2: Step-Up Dosing with AZD5492 Experimental Treatment 1 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 AZD5492 Experimental Treatment 1 Intervention

Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1.

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+