Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

First Patients Screened for Phase 2B Studies with GLPG0634

Published: Monday, July 01, 2013
Last Updated: Monday, July 01, 2013
Bookmark and Share
Galapagos on track with DARWIN Phase 2B program in rheumatoid arthritis.

Galapagos NV has announced that the first rheumatoid arthritis (RA) patients have been screened for enrolment in the Phase 2B clinical program with GLPG0634, a selective JAK1 inhibitor.

The DARWIN Phase 2B program includes two dose finding studies and an open label extension study. The dose finding studies will evaluate the efficacy and safety of GLPG0634 with 24 weeks of treatment in 875 moderate to severe RA patients refractory to methotrexate.

GLPG0634 is the first selective JAK1 inhibitor in development for RA. The results of two 4-week Phase 2A clinical studies demonstrated the rapid clinical benefit and favorable safety profile of the drug, and supported the selection of the GLPG0634 doses that will be evaluated in the current Phase 2B program.

Galapagos started the 24-week global DARWIN Phase 2B program in RA to identify the dose and dose-regimen that offers optimal efficacy and safety of GLPG0634 in patients with moderate to severe RA.

Galapagos expects to report completion of recruitment by mid-2014 and 12-week topline data from the Phase 2B program in Q4 2014.

"GLPG0634 has shown a rapid suppression of disease activity with a good safety profile in the 4-week Phase 2A studies in RA patients. We look forward to seeing the effect of GLPG0634 in a global study, for a longer treatment period, and in a larger and more diverse patient population. The first patients will be recruited in Belgium and New Zealand," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.

Dr Wigerinck continued, "Galapagos is on track in the RA program and is now also preparing for a Phase 2 study with GLPG0634 in Crohn's disease, which will run in parallel with the Phase 2B study in RA. By early 2014, we will have Phase 2 programs with GLPG0634 in RA and Crohn's, both with final readouts before mid-2015."

Details of the DARWIN Phase 2B program
The Phase 2B program, named DARWIN (Drug Against Rheumatoid Arthritis With Selective JAK1 INhibition) includes 2 dose finding studies, DARWIN 1 and DARWIN 2, and an open label extension study, DARWIN 3.

All patients will have received methotrexate (MTX) but no longer have an adequate therapeutic response to this first-line therapy in RA. Patients will not have been exposed to prior biological treatments.

DARWIN 1 will enroll 595 patients who will continue their stable therapy of MTX while receiving GLPG0634 or placebo, whereas in DARWIN 2, 280 patients will stop MTX and receive monotherapy of GLPG0634 or placebo.

All patients who receive placebo or low dose GLPG0634 and do not show improvement after 12 weeks of treatment will be randomized to a higher dose of GLPG0634.

After completion of 24 weeks in either DARWIN 1 or 2, patients may continue open-label GLPG0634 as part of DARWIN 3, an extension study that will collect long-term safety and efficacy data.

GLPG0634 doses in DARWIN 1 and 2 will be 50, 100 and 200 mg per day. In DARWIN 1, these doses will be given as once-daily and twice-daily regimens (daily doses split in two), whereas only once-daily dosing will be evaluated in DARWIN 2. The DARWIN program will recruit patients from Europe, the Americas, Australia, and New-Zealand.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Galapagos Presents Promising Pre-clinical and Phase 1 Results
Company presents results for autotaxin inhibitor GLPG1690 at ERS Annual Meeting.
Saturday, September 26, 2015
Galapagos to Advance Filgotinib to Phase 3 in Rheumatoid Arthritis
Phase 3 start in RA expected in early 2016.
Saturday, September 26, 2015
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Tuesday, August 25, 2015
Patient Recruitment Completed in FITZROY Phase 2 Crohn's Disease Study
First selective JAK1 inhibitor in Phase 2 in Crohn's disease.
Friday, August 07, 2015
Galapagos Completes Recruitment for ORIGIN Phase 2 Trial
Recruitment for the Phase 2 Proof-of-Concept study with GPR84 inhibitor GLPG1205 in ulcerative colitis patients.
Saturday, June 20, 2015
Galapagos DARWIN 1 and 2 Studies have Completed 24 Weeks of Treatment
Topline results from final analyses expected to be released in July and August 2015.
Thursday, June 11, 2015
Galapagos Regains Rights to GLPG1690
Filing for Phase 2 clinical trial in 2015.
Thursday, March 19, 2015
Galapagos Receives €1.6 Million IWT Grant for Hepatitis B Program
Research will focus on compounds against viral protein targets and on inhibitors of host cell proteins.
Thursday, February 12, 2015
Galapagos Receives €2.5 Million IWT Grant for Antibiotic Research
Grant to support the development of Galapagos’ novel antibiotics in a collaboration project.
Saturday, January 24, 2015
Galapagos Completes Recruitment for Darwin 2 Monotherapy Study
Study will begin a series of topline readouts starting around end of the first quarter 2015.
Monday, November 24, 2014
Galapagos Presents Favorable Phase 1 Data for IBD Target
Galapagos NV discloses GPR84 as a promising novel target for treating inflammatory bowel disease during an oral presentation at United European Gastroenterology Week in Vienna.
Tuesday, October 21, 2014
Bart Filius Joins Galapagos as CFO
Bart will join the Executive Committee of Galapagos and be responsible for Finance, Investor Relations, IT, and Purchasing.
Saturday, October 18, 2014
Galapagos Receives Milestone in Osteoarthritis Alliance with Servier
Company completes the nomination of new pre-clinical candidate in the alliance with Servier.
Thursday, August 07, 2014
Galapagos Receives €2 Million from Osteoarthritis Alliance with Servier
Company is responsible for discovery and development of new candidate drugs.
Tuesday, March 11, 2014
Galapagos Receives €2.3 Million IWT Grant for Fibrosis Research
Aim of IWT grant is to deliver a comprehensive fibrosis research platform.
Tuesday, February 04, 2014
Scientific News
13 Ways to Stop an Unseen Force from Disrupting Weighing
Download a free Mettler Toledo paper to discover how to halt static’s negative effects before the next weigh-in.
Flinders Ig Nobel Winner Cracks Global Anaesthetic
One of the world’s most in-demand anaesthetics can now be produced on the spot, thanks to the thermos-flask sized device that recently won Flinders University inventor Professor Colin Raston an Ig Nobel prize.
Resurrected Proteins Double Their Natural Activity
Researchers demonstrate method for reviving denatured proteins.
Genes That Protect African Children From Developing Malaria Identified
Variations in DNA at a specific location on the genome that protect African children from developing severe malaria, in some cases nearly halving a child’s chance of developing the life-threatening disease, have been identified in the largest genetic association study of malaria to date.
Messing With The Monsoon
Manmade aerosols can alter rainfall in the world’s most populous region.
Potential Target for Treatment of Autism
Grant of $2.4 million will support further research.
Scientists Decode Structure at Root of Muscular Disease
Researchers at Rice University and Baylor College of Medicine have unlocked the structural details of a protein seen as key to treating a neuromuscular disease.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
New Test Detects All Viruses
A new test detects virtually any virus that infects people and animals, according to research at Washington University School of Medicine in St. Louis, where the technology was developed.
Inroads Against Leukemia
Potential for halting disease in molecule isolated from sea sponges.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos