Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

Join For Free

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 3,200+ scientific posters on ePosters
  • More Than 4,600+ 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 TechnologyNetworks.com 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 Starts Phase 1 Study
Company has announced the start of a Phase 1 study with potentiator GLPG2451 for cystic fibrosis (CF).
Tuesday, May 10, 2016
Galapagos, Abbvie Expand Cystic Fibrosis Collaboration
Company has announced that it has expand cystic fibrosis collaboration with Abbvie to reflect the successful expansion of their CF portfolio.
Friday, April 29, 2016
Galapagos Reports Additional Data with Filgotinib
Company has reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn’s disease.
Saturday, April 23, 2016
Galapagos and MorphoSys initiate Phase 1 study
Company has initiated phase 1 study with MorphoSys AG in joint antibody program MOR106.
Friday, April 08, 2016
Galapagos Initiates a Phase 2a Study with GLPG1690
Company has announced that it has initiated a phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis patients.
Thursday, April 07, 2016
Galapagos Starts Saphira Phase 2 Study With Glpg1837 In Cystic Fibrosis Patients
Company has announced its Phase 2 exploratory program of GLPG1837 in patients with cystic fibrosis.
Wednesday, February 17, 2016
Galapagos and Gilead Complete Closing of their Global Collaboration for Filgotinib
Triggers an upfront license fee payment of $300 million and equity investment of $425 million.
Thursday, January 21, 2016
Galapagos Advances CF Clinical Development
Initiation of Phase 1 study with corrector GLPG2222, earning Galapagos a $10 million milestone payment from AbbVie.
Wednesday, January 20, 2016
Galapagos Advances Triple Combination Therapy in Cystic Fibrosis
GLPG2665 enters pre-clinical development and completes the first Galapagos-AbbVie triple combination therapy.
Wednesday, October 21, 2015
Positive Safety and Tolerability for Novel Potentiator GLPG1837
Company presents topline Phase 1 results at the North American Cystic Fibrosis Conference in Phoenix.
Saturday, October 10, 2015
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
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Dengue Virus Exposure May Amplify Zika Infection
Researchers at Imperial College London have found that the previous exposure to the dengue virus may increase the potency of Zika infection.
Gender Determination in Forensic Investigations
This study investigated the effectiveness of lip print analysis as a tool in gender determination.
Identifying Novel Types of Forensic Markers in Degraded DNA
Scientists have tried to verify the nucleosome protection hypothesis by discovering STRs within nucleosome core regions, using whole genome sequencing.
Proteins in Blood of Heart Disease Patients May Predict Adverse Events
Nine-protein test shown superior to conventional assessments of risk.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Starving Stem Cells May Enable Scientists To Build Better Blood Vessels
Researchers from the University of Illinois at Chicago College of Medicine have uncovered how changes in metabolism of human embryonic stem cells help coax them to mature into specific cell types — and may improve their function in engineered organs or tissues.
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!