Status:
TERMINATED
Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This was a Phase 1b, randomized, placebo-controlled, participant- and investigator- blinded, two-part non-confirmatory multiple ascending dose (MAD) study in adult patients aged 18-65 (inclusive) with...
Eligibility Criteria
Inclusion
- 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, unless the medication has been discontinued due to intolerance, inadequate response, or patient/physician decision:
- 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. 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. If the patient is not on any medications listed above, they must have been off these medications for at least 12 weeks prior to dosing.
Exclusion
- 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.
- Systemic 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05203419
Start Date
March 15 2022
End Date
June 4 2023
Last Update
October 9 2024
Active Locations (1)
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1
Novartis Investigative Site
Berlin, Germany, 10117