Date: 2014-01-29
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Galapagos (Belgium)
Product: GLPG0634
Action
mechanism: GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile.
Disease: Crohn\'s disease
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Belgium, Czech Republic, France, Germany, Hungary, Poland, Romania, Russian Federation, UK
Trial
details: 180 patients suffering from active Crohn\'s disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects\' quality of life will be evaluated. (NCT02048618)
Latest
news: * On January 29, 2014, Galapagos announced that the first clinical centers have been opened for enrolment in the Phase 2 clinical study in Crohn’s disease with GLPG0634, a selective JAK1 inhibitor. The Phase 2 study will evaluate the efficacy and safety of GLPG0634 during 20 weeks of treatment in 180 patients with active Crohn’s disease. The design of the study will evaluate induction of disease remission and explore early maintenance of its beneficial effects, potentially enabling a rapid entry into Phase 3 studies. Galapagos will fund and conduct the Phase 2 study in Crohn’s disease, recruiting patients in approximately 49 clinical centers throughout Western and Eastern Europe. Upon successful completion of the Crohn’s study, AbbVie will pay Galapagos $50 million. Galapagos expects to read out topline results in Q2 2015. The Phase 2 study in Crohn’s disease will be performed in parallel with the Phase 2B program for GLPG0634 in rheumatoid arthritis ), which includes two dose-finding studies of 24 weeks of treatment in 875 moderate to severe RA patients refractory to methotrexate, and an open label extension study. Galapagos expects to report 12-week topline data from the Phase 2B RA program in Q4 2014, and 24-week data in Q1 2015. AbbVie has the exclusive right to license GLPG0634 upon completion of the Phase 2B RA studies.
