NCT04736953Not yet recruitingPhase 2
Sirolimus Treatment Of Patients With SLE
Sirolimus Treatment of Patients With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 5 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Phase II Double-blind, placebo-controlled, randomized treatment trial with two arms: one SIROLIMUS arm with 92 patients and one placebo arm with 92 patients. The safety and therapeutic efficacy of SIROLIMUS will be determined within a dosage range of 1 mg/day to 4 mg/day, which will be titrated to tolerance during an initial 3-month open label period, relative to placebo in SLE patients over 12 months followed by a 1-month washout. The proposed study design, known as an enriched enrollment randomized withdrawal (EERW), has major advantages that (1) only people who tolerate SIROLIMUS are randomized, potentially reducing the percentage of dropouts in the randomized phase and (2) it allows participants to use an individualized dosage of study medication, which mimics clinical practice in terms of how SIROLIMUS would be administered. Healthy subjects receive no drugs and serve as controls for in vitro studies.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 4 Dec 2020
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- State University of New York - Upstate Medical University
- Diseases
- Lupus (SLE)
- NCT number
- NCT04736953
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From 1 Jan 2025 to the primary completion date, 1 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving cyclophosphamide within 3 months;
- Patients receiving rituximab within 12 months or other biologic therapy within five half lives;
- Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus);
Other illness
- Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events;
- Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients with oral steroid-dependent asthma;
- Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening;
Lab values
- Abnormal laboratory test results: hemoglobin ≤ 8 g/L (8 g/dL), platelet count ≤ 70 x 109/L (70,000 cells/mm³), white blood cell count ≤ 2.0 x 109/L (2,000 cells/mm³), neutrophils: ≤ 1.5 X 109/L, proteinuria \> 3 g/day measured by 24 hour collection or spot urine protein to creatinine ratio of \>3;
- Glomerular filtration rate (GFR) \< 50 mL/min/1.73 m², any other clinically significant abnormal screening laboratory results as evaluated by the Investigator;
Other
- Acute SLE flare threatening vital organs;
- Pregnant or lactating;
- Female subjects who are planning to become pregnant during the study or within 3 months after last dosing or male subjects who are considering fathering a child within 3 months after last dosing;
- Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening (which is considered sufficient time to revert GSH to pre-treatment levels;
- Patients enrolled in other interventional trials.
Who the study is looking for
- Age \> 18;
- Male or female;
- ≥ 4 ACR SLE classification criteria;
- Positive ANA at a titer of ≥ 1/80;
- Stable immunosuppressants (MMF ≤ 3 g/day, azathioprine ≤ 100 mg/day; methotrexate ≤ 15 mg/day) and/or antimalarials (hydroxychloroquine ≤ 400 mg/day) for 30 days prior to screening; stable oral corticosteroids for 2 weeks prior to screening; ≤ 20 mg/day prednisone or equivalent; stable belimumab for 90 days prior to screening;
- BILAG 2004 index (3) level A disease activity in ≥ 1 organ/system except renal or central nervous system or (ii) BILAG 2004 index level B disease activity in ≥ 2 organs/systems if no level A disease activity is present and (iii) SLEDAI ≥ 6;
- Enrollment is approved by adjudication committee.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.