Date: 2014-09-09
Type of information: Completion of patient enrollment
phase: 2b
Announcement: completion of patient enrollment
Company: Biotest (Germany)
Product: tregalizumab (BT-061)
Action
mechanism: Tregalizumab is an immunomodulator anti-CD4 monoclonal antibody that selectively activates regulatory T cells.
Disease: active rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: Bulgaria, Canada, Czech Republic, Estonia, Germany, Hungary, Lithuania, Mexico, Poland, RussianFederation, Serbia, Slovakia, Sweden, Ukraine, USA
Trial
details: T cell REgulating Arthritis Trial 2b (TREAT 2b) is a 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase. Primary end point is the proportion of subjects who achieve an ACR20 at Week 12 following treatment with tregalizumab (25 mg, 100 mg or 200 mg) + MTX compared with subjects treated with placebo + MTX. (NCT01999192)
Latest
news: * On September 9, 2014, Biotest announced that the last patient has been included into the Phase IIb study assessing the efficacy and safety of tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis. The TREAT 2b (T cell REgulating Arthritis Trial 2b) trial is currently underway in 14 countries and more than 80 study centres in Eastern and Western Europe, the USA, Canada and Mexico. Treatment of patients in the TREAT 2b study continues as planned. Therefore the study is on track and Biotest expects, that the assessment of the endpoints of the study is achieved end of 1st quarter 2015 with top-line results to be reported in the 2nd quarter 2015. Key data from the main part of TREAT 2b will be the basis for start of Phase III clinical development. * On March 21, 2013, Biotest announced that it intends to start an additional Phase IIb trial with up to 350 patients with tregalizumab (BT-061), a monoclonal antibody in development for the treatment of rheumatoid arthritis. Tregalizumab will be administered in combination with methotrexate for a treatment period of six months. Patients showing a therapeutic response can be treated for an extended period (so called \'Extension Phase\'). The drug is manufactured at Biotest\'s own facility in Boca Raton, Florida. The patients will receive multiple subcutaneous administrations. The study will be conducted in multiple clinical centers in different regions of the world including the USA, Canada and Europe. The decision for Biotest\'s biggest Phase IIb trial ever, is based on first results of an interim analysis of the currently ongoing clinical trial (study 979) in which patients are being treated over twelve weeks with the antibody in combination with methotrexate.
