Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

NCT02665364 | Terminated Phase 2 Results DMC

• 1 other identifier: IFN-K-002
• Study Type: interventional
• Target: 185
• Locations: 21 countries
• Sites: 101

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in IFN Gene Signature at W36

  The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes.

  Baseline and Last Available Value (LVA) between week 24 and week 36

• Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36

  British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36: * All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and * No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and * No worsening in SLEDAI-2K total score at W36 compared with baseline, and * No deterioration in Physician Global Assessment (PGA) (\< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and * No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS\* between W24 and W36 (\*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36).

  At Week 36

Secondary Outcomes (10)

• Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36

  W36 (9 months)

• Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36

  At Week 36

• BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36

  Last Available Value (LVA) between week 24 and week 36

• SELENA-SLEDAI - Change From Baseline to Week 36

  Baseline and Week 36

• SLICC/ACR-DI Change From Baseline at Week 36

  Baseline and Week 36

Other Outcomes (1)

• CS Mean Daily Dose at W36

  At W36

Study Arms (2)

IFNα-Kinoid

EXPERIMENTAL

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.

Biological: IFNα-Kinoid; Other: ISA 51 VG

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo; Other: ISA 51 VG

Interventions

IFNα-Kinoid BIOLOGICAL

IFNα-Kinoid

Placebo OTHER

Placebo

ISA 51 VG OTHER

IFNα-Kinoid; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neovacs: lead

Study Sites (101)

Research Site

Little Rock, Arkansas, 72205, United States

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La Jolla, California, 92037, United States

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Los Angeles, California, 90017, United States

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Fort Lauderdale, Florida, 33309, United States

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Fort Myers, Florida, 33901, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33134, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32810, United States

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Tampa, Florida, 33614, United States

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Charlotte, North Carolina, 28210, United States

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Oklahoma City, Oklahoma, 73104, United States

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Austin, Texas, 78731, United States

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Buenos Aires, Argentina

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Brussels, 1200, Belgium

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Santiago, 7500710, Chile

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Santiago, 7501126, Chile

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Santiago, 7510047, Chile

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Santiago, 7510186, Chile

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Santiago, 7640881, Chile

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Medellín, Antioquia, 050034, Colombia

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Barranquilla, 080002, Colombia

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Bogotá, 110221, Colombia

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Bogotá, 111211, Colombia

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Bucaramanga, 680003, Colombia

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Zipaquirá, 250252, Colombia

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Zagreb, 10000, Croatia

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Pessac, Bordeaux, 33600, France

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Lille, 59037, France

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Marseille, 13003, France

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Montpellier, 34295, France

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Paris, 75679, France

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Strasbourg, 67098, France

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Tbilisi, 0159, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0186, Georgia

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Bad Nauheim, 61231, Germany

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Berlin, 14059, Germany

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Hanover, 130625, Germany

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Mainz, 55131, Germany

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Munich, 80639, Germany

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Rome, Roma, 00161, Italy

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Bologna, 40138, Italy

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Milan, 20122, Italy

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Verona, 37134, Italy

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Cuernavaca, 62290, Mexico

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Guadalajara, 44130, Mexico

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Guadalajara, 44160, Mexico

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Guadalajara, 44280, Mexico

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Guadalajara, 44500, Mexico

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Guadalajara, 44690, Mexico

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León, 37000, Mexico

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México, 06700, Mexico

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México, 07760, Mexico

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Chisinau, 2025, Moldova

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Chisinau, 2026, Moldova

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Lima, 13, Peru

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Lima, 27, Peru

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Lima, 29, Peru

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Lima, 31, Peru

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Lima, 33, Peru

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Lima, 41, Peru

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Cebu, 6000, Philippines

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Davao City, 8000, Philippines

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Manila, 1000, Philippines

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Quezon, 1102, Philippines

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Bytom, 41-902, Poland

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Krakow, 31-121, Poland

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Poznan, 61-397, Poland

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Sosnowiec, 41-200, Poland

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Szczecin, 71 - 252, Poland

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Warsaw, 02-691, Poland

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Wroclaw, 52-416, Poland

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Chelyabinsk, 454076, Russia

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Kemerovo, 650000, Russia

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Kemerovo, 650066, Russia

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Moscow, 119333, Russia

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Omsk, 644024, Russia

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Omsk, 644111, Russia

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Orenburg, 460018, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 196066, Russia

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Saratov, 410054, Russia

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Yekaterinburg, 620102, Russia

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Seoul, 07061, South Korea

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Seoul, 07345, South Korea

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Lausanne, 1011, Switzerland

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Taichung, 40201, Taiwan

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Taichung, 40402, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taipei, 114, Taiwan

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Sfax, 3029, Tunisia

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Sousse, 4000, Tunisia

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Sousse, Tunisia

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Tunis, 1007, Tunisia

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Tunis, 1008, Tunisia

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Related Publications (2)

• 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.

  PMID: 33687069 DERIVED

• 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.

  PMID: 31871140 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

montanide ISA 51

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Head of Regulatory Affairs
• Organization: Neovacs

info@neovacs.com

+33153109300

Study Officials

• Frédéric Houssiau, MD, PhD

  Head of Rhumatology, UCL, Brussels, Belgium

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: January 27, 2016
• Study Start: September 23, 2015
• Primary Completion: March 15, 2018
• Study Completion: February 4, 2020
• Last Updated: April 9, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

AR (1); CO (6); CR (1); MO (2); PL (7); US (13); PH (4); CL (5); TH (2); DE (5); FR (6); KR (2); IT (6); RU (11); PE (6); ME (9); BE (1); GE (3); CH (1); TW (5); TU (5)