A Single Dose Clinical Trial to Study the Safety of ART-I02 in Patients With Arthritis

Phase 1 Unknown 12 enrolled Arthrogen Centre for Human Drug Research (CHDR) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and tolerability of a single intra-articular administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type 2/5 vector in subjects with Rheumatoid Arthritis (RA) or Osteoarthritis (OA) and active arthritis of the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal (PIP), or distal interphalangeal (DIP) joints.

Timeline

Start: 2017-04-20
Primary completion: 2022-09
Completion: 2022-09

Publications

Vrouwe JPM, Meulenberg JJM, Klarenbeek NB, Navas-Canete A, Reijnierse M, Ruiterkamp G, Bevaart L, Lamers RJ, Kloppenburg M, Nelissen RGHH, Huizinga TWJ, Burggraaf J, Kamerling IMC. Administration of an adeno-associated viral vector expressing interferon-beta in patients with inflammatory hand arthritis, results of a phase I/II study. Osteoarthritis Cartilage. 2022 Jan;30(1):52-60. doi: 10.1016/j.joca.2021.09.013. Epub 2021 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ART-I02	Gene therapy (AAV / viral vector)	3e+11 vg	Other
Subject	ART-I02	Gene therapy (AAV / viral vector)	6e+11 vg	Other
Subject	ART-I02	Gene therapy (AAV / viral vector)	1.2e+12 vg	Other
Subject	ART-I02	Gene therapy (AAV / viral vector)	3e+12 vg	Other
Subject	ART-I02	Gene therapy (AAV / viral vector)	6e+12 vg	Other
Subject	ART-I02	Gene therapy (AAV / viral vector)	1.2e+13 vg	Other

A Single Dose Clinical Trial to Study the Safety of ART-I02 in Patients With Arthritis

Summary

Timeline

Publications

Drugs

Indications