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

October 8, 2024 updated by: Galapagos NV

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD).

Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
  • Austria
      • Vienna, Austria, 1090
        • AKH Wien - Universitatsklinik fur Innere Medizin III
  • Germany
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
  • India
      • Ahmedabad, India, 380052
        • Kaizen Hospital
      • Bīkaner, India, 334001
        • SP Medical college & AG Hospitals
      • Dehli, India, 110026
        • Maharaja Agrasen Hospital
      • Hyderabad, India, 500082
        • Nizam's Institute of Medical Sciences
      • Jaipur, India, 302001
        • SR Kalla Memorial Gastro and General Hospital
      • Jaipur, India, 302004
        • SMS Medical College and Hospital
      • Kolhapur, India, 416006
        • Om Sai Onco Surgery Center
      • Kolkata, India, 700020
        • Institute of Post Graduate Medical Education and Research (IPGMER)
      • Kota, India, 324005
        • Radha Krishna Critical Care & General Hospital
      • Ludhiana, India, 141001
        • Dayanand Medical College & Hospital
      • Nagpur, India, 440008
        • Rahate Surgical Hospital
      • Nagpur, India, 440012
        • Crescent Hospital And Heart Centre
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110062
        • Batra Hospital and Medical Research Center
      • Rajkot, India, 360005
        • Shri Griraj Multispeciality Hospital
      • Secunderabad, India, 500003
        • Gandhi Hospital
      • Secunderabad, India, 50003
        • Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
      • Surat, India, 395009
        • BAPS Pramukh Swami Hospital
      • Vadodara, India, 390007
        • Sterling Hospital
      • Varanasi, India, 221005
        • Samvedna Hospital
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences
    • Mumbai
      • Parel, Mumbai, India, 400012
        • Seth GS medical college and KEM Hospital
  • New Zealand
      • Newtown, New Zealand, 6021
        • Wellington Hospital
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
      • Kraków, Poland, 31-501
        • Krakowskie Centrum Medyczne
      • Sopot, Poland, 81-756
        • Endoskopia Sp.z o.o
      • Warsaw, Poland, 00-332
        • Bodyclinic Alicja Pasnik
      • Łódź, Poland, 90-302
        • Santa Familia, Centrum Badan Profilaktyki i Leczenia
  • Romania
      • Timisoara, Romania, 300594
        • S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
  • Russian Federation
      • Moscow, Russian Federation, 105554
        • Olla-Med, Llc
      • Penza, Russian Federation, 440026
        • State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
      • Rostov-on-Don, Russian Federation, 344022
        • State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
      • Saint Petersburg, Russian Federation, 196247
        • Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
  • Ukraine
      • Kharkiv, Ukraine, 61137
        • Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
      • Kiev, Ukraine, 01030
        • Kyiv City Clinical Hospital #18, Proctology Department
      • Vinnitsa, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
      • Vinnitsya, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
      • Vinnitsya, Ukraine, 21029
        • Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
      • Vinnytsya, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
      • Zaporizhzhya, Ukraine, 69096
        • Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
      • Zaporizhzhya, Ukraine, 69600
        • Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego
    • Florida
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Research Institute
      • Miami, Florida, United States, 33136
        • University of Miami Crohn's and Colitis Center
    • Georgia
      • Norcross, Georgia, United States, 30093
        • One Health Research Clinic, Inc
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4 months. Endoscopic and histopathologic documentation of UC or CD.
  • Have moderately to severely active UC or CD

Key Exclusion Criteria:

  • Previously or currently documented problems with male reproductive health
  • Current use of sulfasalazine or its use within the 26 weeks leading up to Screening; sulfasalazine is not permitted at any point during the study
  • Current use of corticosteroids at a dosage of > 20 mg/day of prednisone or equivalent at randomization
  • Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon
  • Active tuberculosis (TB) or untreated latent tuberculosis
  • Use of concomitant prohibited medications as outlined by protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Filgotinib
Participants received filgotinib up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 or had disease worsening after Week 13 and prior to Week 26, and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib for up to Week 13. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to a standard of care (SOC) regimen selected by the investigator and entered the MP for up to 52 weeks.
Drug: Filgotinib
200 mg 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.
Placebo Comparator: Placebo
Participants received placebo (matched to filgotinib) up to Week 13 in the DB phase (Part A). At Week 13, participants who were IBD responders, without meeting pre-specified sperm decrease thresholds, continued DB treatment up to Week 26 (Part B). Participants who were IBD non-responders at Week 13 or had disease worsening after Week 13 and prior to Week 26, and whose sperm parameters did not meet a prespecified decrease threshold, entered the OL Phase and received OL filgotinib for up to Week 13. At Week 26/OL Week 13, participants who were IBD responders and who had not experienced disease worsening, and whose sperm parameters did not meet a prespecified decrease threshold, continued receiving the same study drug they were responding to as part of the LTE for up to 195 weeks. Participants who met pre-specified sperm decrease threshold(s) at any postbaseline visit discontinued study drug and switched to SOC regimen selected by the investigator and entered the MP for up to 52 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Time Frame: Baseline to Week 13
Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperm cells/mL. Percentage change = ([mean at Week 13 - baseline] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.
Baseline to Week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Sperm Total Motility at Week 13
Time Frame: Baseline, Week 13
The normal range for sperm total motility is ≥40%.
Baseline, Week 13
Change From Baseline in Ejaculate Volume at Week 13
Time Frame: Baseline, Week 13
The normal range for ejaculate volume is ≥1.5 mL.
Baseline, Week 13
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Time Frame: Baseline, Week 13
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Baseline, Week 13
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Time Frame: Baseline to Week 26

IBD responder: For ulcerative colitis (UC), a participant who had a reduction of ≥2 in partial Mayo Clinic Score (pMCS) compared with baseline at specified time. For Crohn's disease (CD), a participant who had a reduction of ≥100 points in total Crohn's Disease Activity Index (CDAI) score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥220 to ≤250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for sperm concentration is ≥15 million sperm cells/mL.
Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 26
Time Frame: Baseline, Week 26

IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for sperm total motility is ≥40%.
Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
Time Frame: Baseline, Week 13
The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate.
Baseline, Week 13
Change From Baseline in Total Sperm Count at Week 26
Time Frame: Baseline, Week 26

IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate.
Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
Time Frame: Baseline, Week 13
The normal range for sperm concentration is ≥15 million sperm cells/mL.
Baseline, Week 13
Change From Baseline in Sperm Concentration at Week 26
Time Frame: Baseline, Week 26

IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for sperm concentration is ≥15 million sperm cells/mL.
Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 26
Time Frame: Baseline, Week 26

IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for ejaculate volume is ≥1.5 mL.
Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Time Frame: Baseline, Week 26

IBD responder: For UC, a participant who had a reduction of ≥ 2 in pMCS compared with baseline at specified time. For CD, a participant who had a reduction of ≥ 100 points in total CDAI score compared with baseline at specified time. A participant with a baseline total CDAI score of ≥ 220 to ≤ 250 was considered an IBD responder if a CDAI score of <150 was attained at specified time.

IBD nonresponder: For UC or CD, a participant who did not fulfil the definition of IBD responder at specified time.

pMCS score: Sum of 3 subscores (rectal bleeding, stool frequency, and physician's global assessment) excluding endoscopic subscore; ranging from 0 (none) to 9 (severe disease).

CDAI score: A weighted sum of 8 disease activity variables with scores ranging from 0 to over 600, where higher score = higher disease activity.

The normal range for percent normal sperm morphology is ≥30% normal sperms.
Baseline, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Galapagos Study Director, Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-418-4279
  • 2017-000402-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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