NCT04077684CompletedPhase 2
Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2024
Brief summary (registry, in English)
The management of active systemic lupus erythematosus (SLE) is challenging due to the heterogeneous nature of the disease and lack of specific treatment. Current treatment regimens mainly rely on corticosteroids and immunosuppressive agents which are associated with substantial adverse effects including various infections. Therefore, there is an unmet need for new therapies with better efficacy and less adverse effects. Defective IL-2 production contributes to the unbalanced immune system in SLE. Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE. It was suggested that low-dose IL-2 treatment promoted regulatory T cells (Treg) and inhibited T helper 17 cells (Th17) and follicular helper T cells (Tfh). The immunological rebalancing was associated with the induction of remission in SLE patients. To establish that which low doses of IL-2 would be more efficacious and safe in active SLE, we carried out a multi-center, randomized, double-blind, placebo-controlled trial of three doses of IL2 (0.2 MIU, 0.5 MIU or 1 MIU) versus placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 1 Sept 2019
- Start date
- 10 Sept 2019
- Primary completion date
- 7 Mar 2024
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT04077684
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 152
- From 10 Sept 2019 to the primary completion date, 7 Mar 2024
- 1 site in 1 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
- therapy with other immunosuppressors;
Other illness
- allergic to IL-2, corticosteroids, hydroxychloroquine, cyclophosphamide or mycophenolate mofetil
- hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase ≥ 2 times of the upper limit of the normal range);
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- Serious infection such as bacteremia, sepsis;history of chronic infection;
- active infection (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus or Mycobacterium tuberculosis);
- history vision and visual field disorders, cataract；
- severe comorbidities including heart failure (≥ grade III NYHA)
- complicated with other autoimmune diseases;
- History of administration of rituximab or other biologics within 6 months;
Other
- active severe neuropsychiatric manifestations of SLE;
- pregnancy or lactation in females.
- active peptic ulcers；
- participate in other clinical trial within 4 weeks;
Who the study is looking for
- Meet the 1997 revised classification criteria of the American College of Rheumatology
- SLE disease activity index(SLEDAI) ≥ 8
- age:18 to 75 years, weight 45-80Kg
- Patients had an inadequate response to standard treatment for ≥ 3 months. The background treatment included corticosteroids (≤1.0 mg/kg), hydroxychloroquine, cyclophosphamide , mycophenolate mofetil or other immunosuppressants.
- Negative urine pregnancy test
- Written informed consent form
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.