Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)

• Status: Not yet recruiting
• Trial end date: 2024-02-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Fulfills the 2019 EULAR/American College of Rheumatology (ACR) classification criteria for SLE at least 3 months prior to and at screening.

• Patients with mild or moderately active SLE (SLEDAI-2K between 3 and 10, inclusive) at screening. Patients with cutaneous lupus are eligible as long as they satisfy the criteria for systemic lupus.

• Patients must be on stable dose(s) of at least one of the following medications:

• steroid at a dose ≥ 5mg but <30 mg of prednisone (or equivalent) per day,

• antimalarial (hydroxychloroquine/chloroquine/quinacrine) or thalidomide,

• disease modifying anti-rheumatic drugs (DMARDs):

• methotrexate (MTX),

• azathioprine (AZA),

• mizoribine,

• mycophenolate derivates. Combination of anti-malarials and/or thalidomide with other DMARDs is not permitted.

Steroid dose must be stable for at least 4 weeks prior to the first dosing. The dose of the other medications above must be stable for at least 12 weeks prior to the first dosing.

Exclusion Criteria:

• History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.

• Patients with central nervous system (CNS) lupus, active Lupus Nephritis, any type of lupus flare requiring pulse steroid or immunosuppressive therapy with cyclophosphamide, rituximab, calcineurin inhibitors, or others except those permitted in the inclusion criteria.

• Autoimmune disease other than lupus, which would interfere with participation in the study according to the Investigator's judgement. Treated, stable Hashimoto's thyroiditis is not exclusionary.

• Any of the following abnormal laboratory values at Screening or pre-dose Day 1 assessment:

Hemoglobin levels below 8.0 g/dL at screening Eosinophil count >700 mm3 or >2 X Upper Limit of Normal (ULN), whichever is lower.

• History of capillary leak syndrome (CLS).

Other protocol-defined inclusion/exclusion criteria may apply