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Study of IFN-K in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02665364
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : April 29, 2019
Information provided by (Responsible Party):

Brief Summary:

The safety and immunogenicity of the IFN-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with SLE. Preliminary results were promising.

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: IFN-Kinoid Other: Placebo Other: ISA 51 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IFN-Kinoid
IFN-Kinoid + ISA 51
Biological: IFN-Kinoid
Other: ISA 51
Placebo Comparator: Placebo
Placebo + ISA 51
Other: Placebo
Other: ISA 51

Primary Outcome Measures :
  1. Change from baseline in the expression of IFN-induced genes at Week 36 [ Time Frame: 9 months ]
  2. Response to treatment with IFN-K as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response criteria at Week 36 [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Response to treatment with IFN-K, as measured by the SLE Responder Index (SRI)-4 response criteria at Week 36 [ Time Frame: 9 months ]
  2. Number of participants with treatment-related adverse events [ Time Frame: 9 months ]
  3. Number of patients achieving Lupus Low Disease Activity State (LLDAS) [ Time Frame: 9 months and after 9 months every 6 months up to end of long term follow-up (5 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has had a diagnosis of SLE according to current 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 RT-qPCR
  • Has 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, 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 ≥ HSIL on a cervical swab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02665364

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Sponsors and Collaborators
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Study Chair: Frédéric Houssiau, MD, PhD Head of Rhumatology, UCL, Brussels, Belgium

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Responsible Party: Neovacs Identifier: NCT02665364     History of Changes
Other Study ID Numbers: IFN-K-002
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases