A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)

  • STATUS
    Recruiting
  • End date
    May 2, 2024
  • participants needed
    28
  • sponsor
    Novartis Pharmaceuticals
Updated on 23 September 2022
methotrexate
prednisone
hydroxychloroquine
azathioprine
anti-rheumatic drugs
mycophenolate
chloroquine
cutaneous lupus
quinacrine

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.

Description

This is 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 active SLE disease (mild-moderate).This MAD study will be conducted in two parts, Part A and Part B sequentially.

In Part A, after a screening period of up to 6 weeks, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 120 Days.

In Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose to be confirmed). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.

Details
Condition Lupus Erythematosus, Systemic
Treatment Placebo, MHS552
Clinical Study IdentifierNCT05203419
SponsorNovartis Pharmaceuticals
Last Modified on23 September 2022

Eligibility

Yes No Not Sure

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, 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 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
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
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