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Janus Kinase (JAK) Inhibitor

Filgotinib for Inflammatory Bowel Disease (MANTA Trial)

Phase 2

Waitlist Available

Research Sponsored by Galapagos NV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 26

Awards & highlights

MANTA Trial Summary

This trial will study the safety of a potential new drug for inflammatory bowel disease in up to 250 participants. Results from this trial will be combined with another similar trial studying a different group of patients with inflammatory conditions.

Eligible Conditions

Inflammatory Bowel Disease

MANTA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13

Secondary outcome measures

Change From Baseline in Ejaculate Volume at Week 13

Change From Baseline in Ejaculate Volume at Week 26

Change From Baseline in Percent Normal Sperm Morphology at Week 13

+8 more

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936

Nasopharyngitis

Headache

Upper respiratory tract infection

Nausea

Bronchitis

Lumbar spinal stenosis

Abscess oral

Osteitis

Rheumatoid arthritis

Gallbladder empyema

Depression

Myocardial ischaemia

Anaemia

Vulval abscess

100%

80%

60%

40%

20%

Study treatment Arm

Filgotinib 100 mg

Placebo

Filgotinib 200 mg

MANTA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FilgotinibExperimental Treatment2 Interventions

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.

Group II: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgotinib

2017

Completed Phase 3

~7520

Standard of Care

2017

Completed Phase 4

~4420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,614 Total Patients Enrolled

Galapagos NVLead Sponsor

137 Previous Clinical Trials

22,784 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,608 Total Patients Enrolled

Media Library

Filgotinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03201445 — Phase 2

Inflammatory Bowel Disease Research Study Groups: Placebo, Filgotinib

Inflammatory Bowel Disease Clinical Trial 2023: Filgotinib Highlights & Side Effects. Trial Name: NCT03201445 — Phase 2

Filgotinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03201445 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety protocols are in place for those utilizing Filgotinib?

"Our team assigned Filgotinib a score of 2 since the Phase 2 trial only has limited evidence supporting its safety and no data validating efficacy."

Answered by AI

Is this research endeavor open to new enrollees?

"As per clinicaltrials.gov, this particular research endeavour is not presently recruiting patients - the trial was posted on July 11th 2017 and last updated October 11th 2022. Nevertheless, there are 217 other trials that still require participants at present."

Answered by AI

Can I register for this medical experiment?

"This medical research is enrolling 139 patients who have intestinal disorders and whose ages range from 21-65. Furthermore, for acceptance into the study, individuals must provide a minimum 4 month diagnosis of either ulcerative colitis (UC) or Crohn's disease (CD), as well as endoscopic and histopathologic documentation to prove their condition."

Answered by AI

Does this trial encompass individuals of advanced age?

"To be eligible for this medical trial, individuals must fall between the ages of 21 and 65."

Answered by AI

Is this a pioneering clinical trial?

"Since 2014, 8 ongoing trials assessing the efficacy of Filgotinib have been conducted in 192 cities and 49 countries. The initial study was sponsored by Gilead Sciences with 739 participants and concluded its Phase 2 assessment. Subsequently, 18,549 research projects involving this medication have been completed."

Answered by AI

What other exploratory trials have been conducted concerning Filgotinib?

"Presently, 8 clinical trials involving Filgotinib are in operation with 4 of them currently in their third stage. While the majority of these research efforts take place within San Antonio, Texas; 1408 different medical centres globally have active studies related to this medication."

Answered by AI

How many participants are being enlisted for this clinical research project?

"This program is no longer searching for participants, with the last update of October 11th 2022. If you are looking to join a different clinical trial, 209 trials concerning intestinal diseases and 8 Filgotinib studies are currently recruiting patients."

Answered by AI

Could you enumerate the facilities offering this trial within city limits?

"Currently, 10 clinical sites are recruiting participants for this medical trial. These locations include Miami, Norcross and Mentor as well as other cities. To reduce travel needs, it is recommended to select the nearest clinic when enrolling in the study."

Answered by AI