Clinical Trials

Date: 2018-07-08

Type of information: Treatment of the first patient

phase: 1b

Announcement: clinical trial authorization

Company: Arthrogen (The Netherlands)

Product: ART-I02

Action mechanism:

  • gene therapy. ART-I02 is an investigational new drug, expressing human IFN-Beta from a recombinant adeno-associated virus type 5 (rAAV5) under the influence of a promoter, which is induced by an inflammatory stimulus. Due to the relapsing nature of rheumatoid arthritis, therapeutic expression should be maximal during flare-ups of the disease. This is achieved by employing the NF-kB responsive promotor to regulate expression of IFN-Beta. Under inflammatory conditions, the NF-kB responsive promoter will be activated in the synovium and will upregulate the expression of hIFN-Beta and turned down during remission. In this way, transgene expression can be controlled, following the intermittent course of disease.

Disease: rheumatoid arthritis, osteoarthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country: The Netherlands

Trial details:

  • This study will evaluate the safety and tolerability of a single intra-articular administration of ART-I02 (AAV5.NF-kB.IFN-Beta), a recombinant adeno-associated virus (AAV) type 5 vector in subjects with rheumatoid arthritis and active arthritis in the joint. (NCT02727764)

Latest news:

  • • On July 8, 2018, Arthrogen, together with the Centre for Human Drug Research (CHDR), announced that the first three arthritis patients have been enrolled in a phase Ib gene therapy trial for treatment of arthritis with ART-I02. This current clinical phase Ib trial, evaluates the safety, tolerability, pharmacokinetics, immunogenicity and anti-inflammatory activity of ART-I02 treatment in patients with rheumatoid arthritis (RA) or osteoarthritis (OA). In total 12 patients with RA or OA in their hand joints will be included. Parallel to this study, a similar phase Ib trial has started in Canada treating 15 patients with RA in their wrist. The first set of data is expected to be available in Q4 2018.
  • • On February 16 2017.  Arthrogen announced the approval for the ART-I02 gene therapy clinical phase Ib study in patients with rheumatoid arthritis. The clinical trial will focus on rheumatoid arthritis patients who, despite multiple treatments with existing medicines, still suffer from inflamed joints. The new approach aims to stimulate the local production of an anti-inflammatory protein within the inflamed joint by means of a single treatment. This initial trial will be used to examine safety and the first signs of effects. The study will be executed by the Centre for Human Drug Research (CHDR) in Leiden in close collaboration with University Medical Centers in the Netherlands. Arthrogen intends to treat 12 patients. The trial will start recruitment in the first quarter of 2017 with the aim of presenting its results by the end of 2018.

Is general: Yes