Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

PHASE2TerminatedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

July 11, 2017

Primary Completion Date

November 20, 2020

Study Completion Date

October 24, 2023

Conditions
Inflammatory Bowel Disease
Interventions
DRUG

Filgotinib

200 mg tablet administered orally once daily

DRUG

Placebo

Placebo to match filgotinib tablet administered orally once daily

DRUG

Standard of Care

Locally approved treatment, accepted by medical experts as a proper treatment for IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity.

Trial Locations (56)

1090

AKH Wien - Universitatsklinik fur Innere Medizin III, Vienna

3168

Monash Medical Centre, Clayton

6021

Wellington Hospital, Newtown

21018

Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2, Vinnitsa

Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department, Vinnitsya

Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1, Vinnytsia

21029

"Medical Center LLC Health Clinic, Medical Clinical Investigational Center", Vinnitsya

30093

One Health Research Clinic, Inc, Norcross

30625

Medizinische Hochschule Hannover, Hanover

33136

University of Miami Crohn's and Colitis Center, Miami

34211

Florida Research Institute, Lakewood Rch

38138

Gastro One, Germantown

44060

Great Lakes Gastroenterology Research, LLC, Mentor

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

50003

Institute of Gastroenterology & Liver Disease, Sunshine Hospitals, Secunderabad

61137

"Municipal Health Care Institution Regional Hospital of War Veterans, Therapeutic Department No. 1", Kharkiv

69096

"Municupal Institution Zaporizhzhia City Multidisciplinary Clinic #9 Gastrointestinal Surgery Department,", Zaporizhzhya

69600

"Municipal Non-profit Enterprise Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council,", Zaporizhzhya

71201

Delta Research Partners, Monroe

76012

Texas Clinical Research Institute, Arlington

76092

Texas Digestive Disease Consultants, Southlake

92134

Naval Medical Center San Diego, San Diego

105554

Olla-Med, Llc, Moscow

110026

Maharaja Agrasen Hospital, Dehli

110029

All India Institute of Medical Sciences, New Delhi

110060

Sir Ganga Ram Hospital, New Delhi

110062

Batra Hospital and Medical Research Center, New Delhi

141001

Dayanand Medical College & Hospital, Ludhiana

196247

"Saint Petersburg State Budgetary Healthcare Institution City Hospital # 26", Saint Petersburg

221005

Samvedna Hospital, Varanasi

300594

S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie, Timișoara

302001

SR Kalla Memorial Gastro and General Hospital, Jaipur

302004

SMS Medical College and Hospital, Jaipur

324005

Radha Krishna Critical Care & General Hospital, Kota

334001

SP Medical college & AG Hospitals, Bīkaner

344022

"State Budgetary Educational Institution of Higher Professional Education Rostov State Medical University of the Ministry of Health of Russian Fedn.", Rostov-on-Don

360005

Shri Griraj Multispeciality Hospital, Rajkot

380052

Kaizen Hospital, Ahmedabad

390007

Sterling Hospital, Vadodara

395002

Surat Institute of Digestive Sciences, Surat

395009

BAPS Pramukh Swami Hospital, Surat

400012

Seth GS medical college and KEM hospital, Pārel

416006

Om Sai Onco Surgery Center, Kolhāpur

440008

Rahate Surgical Hospital, Nagpur

440012

Crescent Hospital and Heart Centre, Nagpur

440026

State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko, Penza

500003

Gandhi Hospital, Secunderabad

500082

Nizam's Institute of Medical Sciences, Hyderabad

700020

Institute of Post Graduate Medical Education and Research (IPGMER), Kolkata

85-079

Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak, Bydgoszcz

31-501

Krakowskie Centrum Medyczne, Krakow

90-302

Santa Familia, Centrum Badan Profilaktyki i Leczenia, Lodz

81-756

Endoskopia Sp.z o.o, Sopot

00-332

Bodyclinic Alicja Pasnik, Warsaw

01030

Kyiv City Clinical Hospital #18, Proctology Department, Kiev

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Galapagos NV

INDUSTRY