Clinical trial NCT02665364: Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα-Kinoid in Adult Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Neovacs
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response.

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.


Eligibility criteria: Inclusion Criteria:

* Has had a diagnosis of SLE according to current American College of Rheumatology (ACR) criteria (4 of 11 ACR 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 lupus nephritis as defined either by the immediate need for cyclophosphamide treatment or by renal BILAG A
* 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

Primary outcomes:
measure: Percent Change From Baseline in IFN Gene Signature at W36
timeFrame: Baseline and Last Available Value (LVA) between week 24 and week 36
measure: Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36
timeFrame: At Week 36
Secondary outcomes:
measure: Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36
timeFrame: W36 (9 months)
measure: Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36
timeFrame: At Week 36
measure: BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36
timeFrame: Last Available Value (LVA) between week 24 and week 36
measure: SELENA-SLEDAI - Change From Baseline to Week 36
timeFrame: Baseline and Week 36
measure: SLICC/ACR-DI Change From Baseline at Week 36
timeFrame: Baseline and Week 36
measure: CLASI Total Activity Change From Baseline at Week 36
timeFrame: Baseline and Week 36
measure: Number of Participants Who Achieved a Composite SRI-4 Including CS ≤7,5mg/Day at Week 36
timeFrame: At Week 36
measure: Number of Participants Who Achieved a Composite SRI-4 Including CS ≤5mg/Day at Week 36
timeFrame: At Week 36
measure: Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36
timeFrame: At week 36
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 9 months
Other outcomes:
measure: CS Mean Daily Dose at W36
timeFrame: At W36
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: La Jolla
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Austin
country: United States
facility: Research Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Medellín
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Zipaquira
country: Colombia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Pessac
country: France
facility: Research Site
state: Bordeaux
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Bad-Nauheim
country: Germany
facility: Research site
city: Berlin
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Rome
country: Italy
facility: Research Site
state: Roma
city: Bologna
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cuernavaca
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Chisinau
country: Moldova, Republic of
facility: Research Site
city: Chisinau
country: Moldova, Republic of
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Cebu
country: Philippines
facility: Research Site
city: Davao
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon
country: Philippines
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sosnowiec
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Sfax
country: Tunisia
facility: Research Site
city: Sousse
country: Tunisia
facility: Research Site
city: Sousse
country: Tunisia
facility: Research Site
city: Tunis
country: Tunisia
facility: Research Site
city: Tunis
country: Tunisia
facility: Research Site
Study officials:
affiliation: Head of Rhumatology, UCL, Brussels, Belgium
name: Frédéric Houssiau, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.