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

NCT05203419 | Terminated Phase 1

• 2 other identifiers: CMHS552D121012021-003520-33
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period.

Conditions

Lupus Erythematosus, Systemic

Keywords

Systemic Lupus Erythematosus, Lupus, autoimmune disease, inflammatory disease, inflammation

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

  Numbers of participants with AEs and SAEs, and other safety data such as vital signs, electrocardiograms (ECG) and laboratory results

  Part A: up to 12 weeks; Part B: up to 20 weeks

Secondary Outcomes (3)

• Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552

  Part A: up to Day 78; Part B: up to Day 134

• Maximum Observed Blood Concentrations (Cmax) for MHS552

  Part A: up to Day 78; Part B: up to Day 134

• Time to Reach Maximum Blood Concentrations (Tmax) of MHS552

  Part A: up to Day 78; Part B: up to Day 134

Study Arms (6)

Part A: Cohort 1 - MHS552 low dose

EXPERIMENTAL

Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part A: Cohort 1, 2, 3 - Placebo

PLACEBO COMPARATOR

Participants will receive placebo once weekly subcutaneously for 4 weeks

Drug: Placebo

Part A: Cohort 2 - MHS552 medium dose

EXPERIMENTAL

Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part A: Cohort 3 - MHS552 high dose

EXPERIMENTAL

Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks

Drug: MHS552

Part B: MHS552

EXPERIMENTAL

Participants will receive MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks

Drug: MHS552

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo once weekly subcutaneously for 12 weeks

Drug: Placebo

Interventions

MHS552 DRUG

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

Part A: Cohort 1 - MHS552 low dose; Part A: Cohort 2 - MHS552 medium dose; Part A: Cohort 3 - MHS552 high dose; Part B: MHS552

Placebo DRUG

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

Part A: Cohort 1, 2, 3 - Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Related Links

• Study Results
• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases; Inflammation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 15, 2022
• Primary Completion: June 4, 2023
• Study Completion: June 4, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)