Study of an Anti-TLR4 mAb in Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2018-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovImmune SA
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Male and female patients

• Age >= 18 years old

• BMI: < 30 and > 18

• Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis

• Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender joints out of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints

• C-reactive protein (CRP) level > 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR > 30mm/hr

• Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening

• ACPA-positive RA patients

• Women must be postmenopausal (> 12 months without menses) or surgically sterile or using two effective contraception methods for at least 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period)

• Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period)

• Patients must give written informed consent for study participation

Exclusion Criteria:

• A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome

• Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening

• Previous multiple administrations of any biological DMARD or targeted synthetic DMARD

• Known primary immunodeficiency

• Pregnant or breastfeeding women

• Suspicion of active or latent tuberculosis

• HIV, HCV, HBV infection

• Infection reported during screening not recovered 72h prior to first dose

• History of anaphylactic reactions to any protein therapeutics or excipients

• Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma

• Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization

• Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia

• Major psychiatric or neurological disorder