Systemic Lupus ErythematosusPhase 1/2NCT01058343
Safety of IFNa Kinoid in Systemic Lupus Erythematosus
A Phase 1/2 study testing IFN-K in people with Systemic Lupus Erythematosus, run by Neovacs at 15 sites in 6 countries.
Trial summary
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- IFN-K
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Mar 2010to Jun 2016
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria (4 of 11 ACR criteria),
- 2. SLEDAI ≥4 and ≤10,
- 3. Positive Anti-nuclear Antibodies (ANA) and/or Positive anti-dsDNA antibodies
- 4. Male or female between 18 and 50 years of age
- 5. Current immunity to measles, mumps, rubella and varicella, as evidenced by positive IgG titers at the time of screening,
- 6. For subjects recruited during local influenza season, current vaccination against seasonal influenza at least 7 days prior to randomization,
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- 7. Vaccination against H1N1 influenza at least 7 days prior to randomization.
- 8. For subjects with reproductive potential (males and females), use of a reliable means of contraception
- 9. Written informed consent obtained from the subject.
Who cannot join
- 1. Any serious manifestation of lupus at entry, that, in the opinion of the investigator is likely to require initiation of off-protocol medication changes during the course of the study and in particular no BILAG A score,
- 2. Any non-SLE manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial,
- 3. Received > 20 mg/day of prednisone equivalent for > 7 days during the 30 days prior to screening,
- 4. Currently receiving or having received pulse dose corticosteroids or intravenous immunoglobulin (IVIg) within 3 months prior to screening,
- 5. Received cyclophosphamide within 3 months prior to screening,
- 6. Received a monoclonal antibody during the 6 months prior to screening,
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- 7. Previously received an investigational treatment directed against IFNa,
- 8. Received B-cell depleting therapy (e.g. Rituximab) within 12 months
- 9. Received IV antibiotics during the 30 days prior to screening,
- 10. Significant electrocardiogram (ECG) abnormalities ,
- 11. Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator could represent active infection, latent tuberculosis or treatable manifestation of lupus,
- 12. Any laboratory abnormality that is clinically relevant
- 13. History of malignancy except completely excised basal cell carcinoma,
- 14. Congenital immune deficiency,
- 15. Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV),
- 16. Frequent recurrences of oral or genital herpes simplex lesions (≥ 6 / year),
- 17. Episode of shingles within one year of screening,
- 18. Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV) or HBV (HBsAg, anti-HBc ab) positive,
- 19. Any current signs or symptoms of infection at entry,
- 20. Administration of any live vaccine within the 3 months prior to study entry
- 21. Planned use of any investigational or non-registered product
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
France5 sites
Hopital Claude Huriez
Lille, 59037
Hopital Lapeyronie
Montpellier, 34295
Hopital de la Pitie Salpetriere
Paris
Hopital du Kremlin Bicetre
Paris
Hopital Haut-Leveque
Pessac
Switzerland4 sites
Inselspital
Bern
Geneva University Hospital
Geneva, 1211
Geneva University Hospital
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
Official title: A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.
This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- IFN-K
- Keywords
- SLE
- 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.
IFN-KBiological
3 to 4 IM injections over 3 months
| Study group | Role | What they receive |
|---|---|---|
| IFN-K 1 | Experimental | IFN kinoid dose 1 Receives: Biological: IFN-K |
| IFN-K-2 | Experimental | IFN kinoid dose 2 Receives: Biological: IFN-K |
| IFN-K 3 | Experimental | IFN kinoid dose 3 Receives: Biological: IFN-K |
| IFN-K 4 | Experimental | IFN kinoid dose 4 Receives: Biological: IFN-K |
| Saline | Placebo comparator | saline at same dose as IFN K Receives: Biological: IFN-K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
Measured: study duration
Secondary outcomes (1)
Proportion of patients with anti IFNa antibodies
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovacs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Jorgensen, MD, PhD, Principal investigator, Unité Clinique d'Immuno-Rhumatologie Thérapeutique, Hôpital Lapeyronie, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058343
- Sponsor's protocol ID
- IFN-K-001
- Status last verified
- Mar 2019
- First submitted
- 27 Jan 2010
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ducreux J, Houssiau FA, Vandepapeliere P, Jorgensen C, Lazaro E, Spertini F, Colaone F, Roucairol C, Laborie M, Croughs T, Grouard-Vogel G, Lauwerys BR. Interferon alpha kinoid induces neutralizing anti-interferon alpha antibodies that decrease the expression of interferon-induced and B cell activation associated transcripts: analysis of extended follow-up data from the interferon alpha kinoid phase I/II study. Rheumatology (Oxford). 2016 Oct;55(10):1901-5. doi: 10.1093/rheumatology/kew262. Epub 2016 Jun 28.
PubMed 27354683Lauwerys BR, Hachulla E, Spertini F, Lazaro E, Jorgensen C, Mariette X, Haelterman E, Grouard-Vogel G, Fanget B, Dhellin O, Vandepapeliere P, Houssiau FA. Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon alpha-kinoid. Arthritis Rheum. 2013 Feb;65(2):447-56. doi: 10.1002/art.37785.
PubMed 23203821
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT01058343
- Acronym / sponsor ID
- IFN-K-001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NeovacsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jan 2010 (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.
Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response.
This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IFN-K 1 | Experimental | Biological: IFN-KIFN kinoid dose 1 |
| IFN-K-2 | Experimental | Biological: IFN-KIFN kinoid dose 2 |
| IFN-K 3 | Experimental | Biological: IFN-KIFN kinoid dose 3 |
| IFN-K 4 | Experimental | Biological: IFN-KIFN kinoid dose 4 |
| Saline | Placebo comparator | Biological: IFN-Ksaline at same dose as IFN K |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1. Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria (4 of 11 ACR criteria),
- 2. SLEDAI ≥4 and ≤10,
- 3. Positive Anti-nuclear Antibodies (ANA) and/or Positive anti-dsDNA antibodies
- 4. Male or female between 18 and 50 years of age
- 5. Current immunity to measles, mumps, rubella and varicella, as evidenced by positive IgG titers at the time of screening,
Key exclusion criteria (21 listed)
- 1. Any serious manifestation of lupus at entry, that, in the opinion of the investigator is likely to require initiation of off-protocol medication changes during the course of the study and in particular no BILAG A score,
- 2. Any non-SLE manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial,
- 3. Received > 20 mg/day of prednisone equivalent for > 7 days during the 30 days prior to screening,
- 4. Currently receiving or having received pulse dose corticosteroids or intravenous immunoglobulin (IVIg) within 3 months prior to screening,
- 5. Received cyclophosphamide within 3 months prior to screening,
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 |
|---|---|---|
| IFN-K3 to 4 IM injections over 3 months | Biological | IFN-K 1, IFN-K 3, IFN-K 4, IFN-K-2, Saline |
Primary outcome
Frequency and severity of adverse events
Time frame: study duration
1 secondary outcome
Proportion of patients with anti IFNa antibodies
Time frame: Month 4
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 21 Mar 2019.
- Derived from this study: PubMed 27354683Ducreux J, Houssiau FA, Vandepapeliere P, Jorgensen C, Lazaro E, Spertini F, Colaone F, Roucairol C, Laborie M, Croughs T, Grouard-Vogel G, Lauwerys BR. Interferon alpha kinoid induces neutralizing anti-interferon alpha antibodies that decrease the expression of interferon-induced and B cell activation associated transcripts: analysis of extended follow-up data from the interferon alpha kinoid phase I/II study. Rheumatology (Oxford). 2016 Oct;55(10):1901-5. doi: 10.1093/rheumatology/kew262. Epub 2016 Jun 28.
- Derived from this study: PubMed 23203821Lauwerys BR, Hachulla E, Spertini F, Lazaro E, Jorgensen C, Mariette X, Haelterman E, Grouard-Vogel G, Fanget B, Dhellin O, Vandepapeliere P, Houssiau FA. Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon alpha-kinoid. Arthritis Rheum. 2013 Feb;65(2):447-56. doi: 10.1002/art.37785.
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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.
Christian Jorgensen, MD, PhD principal investigator
Unité Clinique d'Immuno-Rhumatologie Thérapeutique, Hôpital Lapeyronie, Montpellier, France
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IFN-K in people with Systemic Lupus Erythematosus, run by Neovacs at 15 sites in 6 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 9 inclusion and 21 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 21 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 15 sites in France, Switzerland, Croatia, Germany, Belgium and 1 more country. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Frequency and severity of adverse events (time frame: study duration). 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 NCT01058343, which also lists 2 linked publications.
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 21 Mar 2019.