MSC2364447C Phase 1b in Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2016-10-04
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).

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

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• Male or female of 18 to 65 years of age

• Diagnosis of systemic lupus erythematosus (SLE) (at least 4 of the 11 American College of Rheumatology [ACR] classification criteria for SLE) of at least 6 months duration at the Screening visit

• Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to [>=] 1:80) and/or anti-dsDNA antibody (>= 30 international units per milliliter [IU/mL]) at the Screening visit

• At least 1 SLE disease manifestation (assessed by Systemic Lupus Erythematosus Disease Activity Index-2000 [SLEDAI-2K]) other than positive antidsDNA and no central nervous system (CNS) SLE (psychosis, organic brain syndrome, cranial nerve disorder, lupus headache, or new-onset cerebrovascular accident)

• History of vaccinations as follows or vaccination against these pathogens during Screening:

1. Vaccination against Streptococcus pneumoniae with pneumococcal polysaccharide vaccine 23 or pneumococcal 13-valent conjugate vaccine as per local guidelines, and

2. Vaccination against influenza virus (as per local seasonal recommendations). Subjects receiving 1 or more of these vaccinations during screening must have at least 2 weeks between the vaccination(s) and the date of randomization at Day 1.

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Active clinically significant CNS SLE

• Initiation or change in dose of anti-malarial treatment after the screening visit

• Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 40 mg daily prednisone equivalent, use of any injectable corticosteroids, or change in dose of corticosteroids

• Within 2 weeks prior to Screening, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, or nonsteroidal anti-inflammatory drugs (NSAIDs).

• Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine

• Within 2 months prior to Screening or during Screening, use of cyclosporine, tacrolimus, leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease-modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol

• Within 6 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil

• Within 12 months prior to screening or during screening: use of rituximab, belimumab, or any other B cell-depleting or modulating therapies

• Within 1 month prior to Screening or during Screening, vaccination with live or live-attenuated virus vaccine.

• Active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months - Estimated glomerular filtration rate by the Modification of Diet in Renal Disease equation of less than (<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), or recent decline in kidney function, or proteinuria >= 3 gram per day (g/day) (spot urine protein/creatinine ratio >= 3 mg/mg)

• Other protocol defined exclusion criteria could apply