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

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)

ClinicalTrials.gov Identifier: NCT05203419

Novartis Reference Number: CMHS552D12101

Last Update: Apr 20, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Lupus Erythematosus, Systemic
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Mar 15, 2022
Completion date 
Apr 17, 2024
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
MHS552
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
Placebo
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
MHS552
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
Placebo
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
MHS552
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
Placebo
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
MHS552
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Drug
Placebo
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)

Eligibility 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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]