Systemic Lupus ErythematosusPhase 2LUPIL-2NCT02955615
ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
A Phase 2 study testing ILT-101 in people with Systemic Lupus Erythematosus, run by Iltoo Pharma at 25 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- ILT-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 25 sitesin 10 countries
- Study dates
- 18 Jan 2017to 11 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of SLE
- Active SLE
- On stable background therapy for 1 month
- Using highly effective contraception
Who cannot join
- Serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure)
- Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C
- Clinical significant pleuritis or pericarditis
- Type1 Diabetes and/or CROHN's disease
- Use of Benlysta (belimumab) in the past 4 weeks
- Use of Rituximab in the past 6 months
- Vaccination with live attenuated virus in the last month
Trial locations and contacts
25 sites in 10 countries.
25 sites in 10 countries
Mexico5 sites
Hospital AmeriMed Cons.
Cancún
Investigación y Biomedicina
Chihuahua City
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango
Centro Integral en Reumatología S.A. de C.V.
Guadalajara
Clitider S.A. de C.V.
Mexico City, 06700
Germany4 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, 60528
University Clinic Leipzig AöR
Leipzig, 04103
University Clinic Schleswig-Holstein
Lübeck, 23562
France3 sites
Hopital Claude Huriez
Lille, 59037
Hopital Européen
Marseille, 13003
Hôpital Haut Lévèque
Pessac, 33604
Romania3 sites
Neomed
Brasov
Euroclinic Hospital
Bucharest
Sf. Maria Hospital
Bucharest
Spain3 sites
Hospital Vall D'Hebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario y Politécnico La Fe
Valencia
Bulgaria2 sites
University Multiprofile Hospital for Active Treatment
Plovdiv
University Multiprofile Hospital
Sofia
Portugal2 sites
Hospital Prof. Doutor Fernando Fonseca
Amadora
Centro Hospitalar de Lisboa Ocidental
Lisbon
About this study
Official title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- ILT-101, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILT-101Drug
Also called Low dose IL-2
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy.
SLE background therapy includes ...
PlaceboDrug
Induction phase followed by weekly administrations of placebo on top of SLE background therapy.
SLE background therapy includes ...
| Study group | Role | What they receive |
|---|---|---|
| ILT-101 | Experimental | Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 Receives: Drug: ILT-101 |
| Placebo | Placebo comparator | Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRI-4 (SLE responder index)
Number of participants with SRI-4
Measured: at week 12
Secondary outcomes (4)
Incidence of adverse events
Measured: From baseline up to week 24 or 36
Number of participants able to reduce oral steroid dose of 25 and 50%
Measured: From baseline to week 12 or 24
Anti ds-DNA by immunology-based assay
Change in anti-dsDNA as compared to baseline
Measured: From baseline to week 12 or 24
%Tregs
% change in Tregs as compared to baseline
Measured: From baseline to week 12 or 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start18 Jan 2017
- Primary completion27 Aug 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iltoo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Klatzmann, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955615
- Sponsor's protocol ID
- 2016-002
- Other IDs
- 2016-000488-17, 2016
- Acronym
- LUPIL-2
- Status last verified
- Mar 2019
- First submitted
- 17 Oct 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Dec;81(12):1685-1694. doi: 10.1136/ard-2022-222501. Epub 2022 Aug 16.
PubMed 35973803
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT02955615
- Acronym / sponsor ID
- LUPIL-2 / 2016-002
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Iltoo PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILT-101 | Experimental | Drug: ILT-101Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of SLE
- Active SLE
- On stable background therapy for 1 month
- Using highly effective contraception
Key exclusion criteria (7 listed)
- Serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure)
- Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C
- Clinical significant pleuritis or pericarditis
- Type1 Diabetes and/or CROHN's disease
- Use of Benlysta (belimumab) in the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILT-101Also: Low dose IL-2Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ... | Drug | ILT-101 |
| PlaceboInduction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ... | Drug | Placebo |
Primary outcome
SRI-4 (SLE responder index)
Time frame: at week 12
Number of participants with SRI-4
4 secondary outcomes
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
Time frame: From baseline to week 12 or 24
%Tregs
Time frame: From baseline to week 12 or 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 35973803Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Dec;81(12):1685-1694. doi: 10.1136/ard-2022-222501. Epub 2022 Aug 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Klatzmann, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris (AP-HP)
25 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ILT-101 in people with Systemic Lupus Erythematosus, run by Iltoo Pharma at 25 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Mexico, Germany, France, Romania, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRI-4 (SLE responder index) (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.