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Trial record 6 of 7 for:    neovacs

Study of IFN-K in Systemic Lupus Erythematosus

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Neovacs
Sponsor:
Information provided by (Responsible Party):
Neovacs
ClinicalTrials.gov Identifier:
NCT02665364
First received: November 17, 2015
Last updated: March 27, 2017
Last verified: March 2017
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus Biological: IFN-Kinoid Other: Placebo Other: ISA 51 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Neovacs:

Primary Outcome Measures:
  • Change from baseline in the expression of IFN-induced genes at Week 36 [ Time Frame: 9 months ]
  • 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:
  • Response to treatment with IFN-K, as measured by the SLE Responder Index (SRI)-4 response criteria at Week 36 [ Time Frame: 9 months ]
  • Number of participants with treatment-related adverse events [ Time Frame: 9 months ]

Estimated Enrollment: 178
Study Start Date: September 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFN-Kinoid
IFN-Kinoid + ISA 51
Biological: IFN-Kinoid Other: ISA 51
Placebo Comparator: Placebo
Placebo + ISA 51
Other: Placebo Other: ISA 51

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02665364

Contacts
Contact: NEOVACS SA + 33 1 53 10 93 00 contact@neovacs.com

  Show 70 Study Locations
Sponsors and Collaborators
Neovacs
Investigators
Study Chair: Frédéric Houssiau, MD, PhD Head of Rhumatology, UCL, Brussels, Belgium
  More Information

Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT02665364     History of Changes
Other Study ID Numbers: IFN-K-002
Study First Received: November 17, 2015
Last Updated: March 27, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017