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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03201445
Registration number
NCT03201445
Ethics application status
Date submitted
26/06/2017
Date registered
28/06/2017
Date last updated
6/12/2023
Titles & IDs
Public title
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
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Scientific title
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
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Secondary ID [1]
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2017-000402-38
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Secondary ID [2]
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GS-US-418-4279
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Universal Trial Number (UTN)
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Trial acronym
MANTA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care
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.
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.
Treatment: Drugs: Filgotinib
200 mg tablet administered orally once daily
Treatment: Drugs: Placebo
Placebo to match filgotinib tablet administered orally once daily
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 13
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 13
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Secondary outcome [1]
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Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 26
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 26
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Secondary outcome [2]
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Change From Baseline in Sperm Total Motility at Week 13
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Assessment method [2]
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The normal range for sperm total motility is =40%.
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Timepoint [2]
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Baseline, Week 13
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Secondary outcome [3]
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Change From Baseline in Sperm Total Motility at Week 26
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Assessment method [3]
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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%.
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Timepoint [3]
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Baseline, Week 26
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Secondary outcome [4]
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Change From Baseline in Total Sperm Count at Week 13
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Assessment method [4]
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The normal range for total sperm count is = 39 million sperm cells/ejaculate.
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Timepoint [4]
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Baseline, Week 13
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Secondary outcome [5]
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Change From Baseline in Total Sperm Count at Week 26
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 26
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Secondary outcome [6]
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Change From Baseline in Sperm Concentration at Week 13
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Assessment method [6]
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The normal range for sperm concentration is =15 million sperm cells/mL.
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Timepoint [6]
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Baseline, Week 13
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Secondary outcome [7]
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Change From Baseline in Sperm Concentration at Week 26
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 26
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Secondary outcome [8]
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Change From Baseline in Ejaculate Volume at Week 13
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Assessment method [8]
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The normal range for ejaculate volume is =1.5 mL.
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Timepoint [8]
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Baseline, Week 13
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Secondary outcome [9]
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Change From Baseline in Ejaculate Volume at Week 26
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 26
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Secondary outcome [10]
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Change From Baseline in Percent Normal Sperm Morphology at Week 13
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Assessment method [10]
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The normal range for percent normal sperm morphology is =30% normal sperms.
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Timepoint [10]
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Baseline, Week 13
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Secondary outcome [11]
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Change From Baseline in Percent Normal Sperm Morphology at Week 26
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 26
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
21
Years
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Maximum age
65
Years
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/10/2023
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Sample size
Target
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Accrual to date
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Final
139
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Louisiana
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Michigan
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Ohio
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Tennessee
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Texas
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Austria
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Vienna
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Germany
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Hannover
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India
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Gujarat
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India
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Mumbai
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India
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Ahmedabad
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India
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Bikaner
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India
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Dehli
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India
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Hyderabad
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India
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Jaipur
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India
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Kolhapur
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India
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Kolkata
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India
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Kota
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India
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Ludhiana
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India
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Nagpur
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India
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New Delhi
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India
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Rajkot
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India
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Secunderabad
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India
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Surat
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Vadodara
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Varanasi
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New Zealand
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Newtown
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Poland
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Bydgoszcz
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Kraków
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Sopot
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Warsaw
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Lódz
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Penza
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint Petersburg
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Vinnitsa
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Ukraine
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Vinnitsya
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhya
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United Kingdom
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Galapagos NV
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Gilead Sciences
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03201445
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Galapagos Study Director
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Address
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Galapagos NV
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03201445
Download to PDF