Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
NCT ID: NCT02665364
Last Updated: 2020-04-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
185 participants
INTERVENTIONAL
2015-09-23
2020-02-04
Brief Summary
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The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IFNα-Kinoid
IFNα-Kinoid (IFN-K) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
IFNα-Kinoid
ISA 51 VG
Placebo
Placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
Placebo
ISA 51 VG
Interventions
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IFNα-Kinoid
Placebo
ISA 51 VG
Eligibility Criteria
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Inclusion Criteria
* Has SLEDAI-2K ≥ 6
* Has at least 1 BILAG A and/or at least 2 BILAG B
* Has a positive IFN gene signature by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
* Has anti-nuclear antibodies (ANA) ≥ 1:160 and/or anti-dsDNA antibodies ≥ 7.0 IU/mL
* Currently receiving at least one treatment for SLE
Exclusion Criteria
* Has active, severe, neuropsychiatric SLE, defined as neuropsychiatric BILAG A
* Has been treated with corticosteroids (CS) at a dose of \>20 mg of prednisone equivalent/day for \> 7 consecutive days
* Is currently receiving or has received pulse dose CS (≥ 250 mg prednisone equivalent/day)
* Has received potent immunosuppressive drugs
* Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, tumor necrosis factor (TNF) antagonists or another registered or investigational biological therapy
* Has received anti-B-cell therapy (e.g., rituximab, epratuzumab)
* Has frequent recurrences of oral or genital herpes simplex lesions
* Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics
* Has received any live vaccine
* Has used any investigational or non-registered product or any investigational or non-registered vaccine
* Is high-risk human papilloma virus (HPV) positive by rRT-qPCR on a cervical swab
* Has cytological abnormalities ≥ high grade squamous intraepithelial lesions (HSIL) on a cervical swab
18 Years
65 Years
ALL
No
Sponsors
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Neovacs
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric Houssiau, MD, PhD
Role: STUDY_CHAIR
Head of Rhumatology, UCL, Brussels, Belgium
Locations
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Research Site
Little Rock, Arkansas, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Austin, Texas, United States
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Buenos Aires, , Argentina
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Brussels, , Belgium
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Medellín, Antioquia, Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Zipaquirá, , Colombia
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Zagreb, , Croatia
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Pessac, Bordeaux, France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Strasbourg, , France
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Bad Nauheim, , Germany
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Berlin, , Germany
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Hanover, , Germany
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Mainz, , Germany
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Munich, , Germany
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Rome, Roma, Italy
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Bologna, , Italy
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Milan, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Verona, , Italy
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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León, , Mexico
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México, , Mexico
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México, , Mexico
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Chisinau, , Moldova
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Chisinau, , Moldova
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Cebu, , Philippines
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Davao City, , Philippines
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Manila, , Philippines
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Quezon, , Philippines
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Bytom, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Sosnowiec, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Omsk, , Russia
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Orenburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Yekaterinburg, , Russia
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Seoul, , South Korea
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Seoul, , South Korea
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Lausanne, , Switzerland
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Sfax, , Tunisia
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Sousse, , Tunisia
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Sousse, , Tunisia
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Tunis, , Tunisia
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Tunis, , Tunisia
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Houssiau FA, Thanou A, Mazur M, Ramiterre E, Gomez Mora DA, Misterska-Skora M, Perich-Campos RA, Smakotina SA, Cerpa Cruz S, Louzir B, Croughs T, Tee ML. IFN-alpha kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study. Ann Rheum Dis. 2020 Mar;79(3):347-355. doi: 10.1136/annrheumdis-2019-216379. Epub 2019 Dec 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IFN-K-002
Identifier Type: -
Identifier Source: org_study_id
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