RecruitingInterventionalEarly Phase 1Updated Jun 1, 2026
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC) | NCT01738360 | Trialant
TerminatedInterventionalPhase 2Updated Jan 6, 2016
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)
ClinicalTrials.gov ID
NCT01738360
Lead Sponsor
Nantes University HospitalOTHER
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 2
Enrollment
11Actual
Last Update Posted
Jan 6, 2016Estimated
Start Date
Jul 2013
Primary Completion Date
Oct 2015Actual
Completion Date
Oct 2015Actual
Official Title
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)
Brief Summary
Primary objectives :
To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,
To determine the maximum tolerated dose of ATO.
Secondary objectives :
Evaluation of the clinical and biological response of the SLE to ATO,
Time of relapse in case of positive response,
Determination of the efficacy,
Pharmacokinetic study of ATO.
Systemic Lupus
Arsenic trioxide
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Systemic Lupus meeting the ACR (American College of Rheumatology) criteria, progressive either SLEDAI activity score ≥ 4, despite a corticosteroid therapy ≥ 10 mg / d associated with hydroxychloroquine (in the absence of contraindication or intolerance) and / or an immunosuppressive treatment at a stable dose,
Insured,
Availability for hospitalization required by the protocol (conventional and daily hospitalizations).
Exclusion Criteria:
Inability to give their signed informed consent form,
Performans status > 2
QTcorrected space before treatment > 0.45 seconds
Hemoglobin less than 11g/dL
Neutrophils rate below 1 200 / mm3
Platelets rate below 100 Giga / mm3
Previous history of arrhythmia or heart rhythm disorder or other rhythm trouble by referring cardiologist
Heart disorder (progressive pericarditis, valvular disease, ...) according to cardiologist
Family previous history of arrhythmias
Taking drugs that potentially prolong the QT
Hypersensitivity to the active substance of Trisenox® or any of the excipients
Serum potassium ≤ 4 milliequivalent / L
Magnesemia ≤ 1,8 mg / dl
Increase corticosteroids beyond 20 mg / day within 15 days before inclusion
Immunosuppressive treatments, thalidomide introduced within the last 3 months
Biotherapy (rituximab, belimumab, ...) introduced within 6 months prior to inclusion
Pregnancy or lactation
For women of childbearing age, men and their partner : unless effective contraception for the duration of participation in the study that is 7 months
Creatinine clearance <50 ml / min,
Hepatocellular insufficiency (TP <50%), and / or AST (aspartate aminotransferase) / ALT (alanine aminotransferase) / ALP (alkaline phosphatase) > 2N
HBsAg positive, DNA detectable HbS
Infection with HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
Renal or progressive central neurological impairment with possible alternative therapeutic (to be discussed with the principal investigator and scientific board meeting)
Peripheral neuropathy
Unweaned alcoholism
Minor
Patients older than 65 years
Patient having been professionally exposed to arsenic (cleaning electronic circuits for example)