A Phase 2 interventional study of ILT-101 and Placebo in Systemic Lupus Erythematosus, sponsored by Iltoo Pharma. Completed at 25 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Iltoo Pharma · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.
Interleukin 2 (IL-2) plays an important role on immune homeostasis by acting on T lymphocytes. In systemic lupus erythematosus, there is a so called "insufficiency" in a subpopulation of T lymphocytes, the regulatory T cells (Tregs) leading to altered immune balance between regulatory and effector T cells. These cells seem to play a major role in the physiopathology of the disease. Many researches enlighten the fact that this Tregs/Teffs balance can be restored by administering low dose of IL-2. It is thus assumed that treatment with low dose of IL-2 may impact positively the progression of the disease and thus help patients improving their clinical outcomes.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 100 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →This is the only study on the registry with Iltoo Pharma as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Drug: ILT-101
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Drug: Placebo
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...
Also known as: Low dose IL-2
Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...
SRI-4 (SLE responder index)
Number of participants with SRI-4
Time frame: at week 12
Incidence of adverse events
Time frame: From baseline up to week 24 or 36
Number of participants able to reduce oral steroid dose of 25 and 50%
Time frame: From baseline to week 12 or 24
Anti ds-DNA by immunology-based assay
Change in anti-dsDNA as compared to baseline
Time frame: From baseline to week 12 or 24
%Tregs
% change in Tregs as compared to baseline
Time frame: From baseline to week 12 or 24
Plan to share: Undecided
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Low-dose Aldesleukin ILT-101
Lupus Erythematosus, Systemic →