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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03201445




Registration number
NCT03201445
Ethics application status
Date submitted
26/06/2017
Date registered
28/06/2017

Titles & IDs
Public title
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
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
Secondary ID [1] 0 0
2017-000402-38
Secondary ID [2] 0 0
GS-US-418-4279
Universal Trial Number (UTN)
Trial acronym
MANTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 13
Timepoint [1] 0 0
Baseline to Week 13
Secondary outcome [1] 0 0
Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Change From Baseline in Sperm Total Motility at Week 13
Timepoint [2] 0 0
Baseline, Week 13
Secondary outcome [3] 0 0
Change From Baseline in Sperm Total Motility at Week 26
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change From Baseline in Total Sperm Count at Week 13
Timepoint [4] 0 0
Baseline, Week 13
Secondary outcome [5] 0 0
Change From Baseline in Total Sperm Count at Week 26
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Change From Baseline in Sperm Concentration at Week 13
Timepoint [6] 0 0
Baseline, Week 13
Secondary outcome [7] 0 0
Change From Baseline in Sperm Concentration at Week 26
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change From Baseline in Ejaculate Volume at Week 13
Timepoint [8] 0 0
Baseline, Week 13
Secondary outcome [9] 0 0
Change From Baseline in Ejaculate Volume at Week 26
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Timepoint [10] 0 0
Baseline, Week 13
Secondary outcome [11] 0 0
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Timepoint [11] 0 0
Baseline, Week 26

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

Key
Minimum age
21 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/10/2023
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Germany
State/province [10] 0 0
Hannover
Country [11] 0 0
India
State/province [11] 0 0
Gujarat
Country [12] 0 0
India
State/province [12] 0 0
Mumbai
Country [13] 0 0
India
State/province [13] 0 0
Ahmedabad
Country [14] 0 0
India
State/province [14] 0 0
Bikaner
Country [15] 0 0
India
State/province [15] 0 0
Dehli
Country [16] 0 0
India
State/province [16] 0 0
Hyderabad
Country [17] 0 0
India
State/province [17] 0 0
Jaipur
Country [18] 0 0
India
State/province [18] 0 0
Kolhapur
Country [19] 0 0
India
State/province [19] 0 0
Kolkata
Country [20] 0 0
India
State/province [20] 0 0
Kota
Country [21] 0 0
India
State/province [21] 0 0
Ludhiana
Country [22] 0 0
India
State/province [22] 0 0
Nagpur
Country [23] 0 0
India
State/province [23] 0 0
New Delhi
Country [24] 0 0
India
State/province [24] 0 0
Rajkot
Country [25] 0 0
India
State/province [25] 0 0
Secunderabad
Country [26] 0 0
India
State/province [26] 0 0
Surat
Country [27] 0 0
India
State/province [27] 0 0
Vadodara
Country [28] 0 0
India
State/province [28] 0 0
Varanasi
Country [29] 0 0
New Zealand
State/province [29] 0 0
Newtown
Country [30] 0 0
Poland
State/province [30] 0 0
Bydgoszcz
Country [31] 0 0
Poland
State/province [31] 0 0
Kraków
Country [32] 0 0
Poland
State/province [32] 0 0
Sopot
Country [33] 0 0
Poland
State/province [33] 0 0
Warsaw
Country [34] 0 0
Poland
State/province [34] 0 0
Lódz
Country [35] 0 0
Romania
State/province [35] 0 0
Timisoara
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moscow
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Penza
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Rostov-on-Don
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Saint Petersburg
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kharkiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kiev
Country [42] 0 0
Ukraine
State/province [42] 0 0
Vinnitsa
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnitsya
Country [44] 0 0
Ukraine
State/province [44] 0 0
Vinnytsya
Country [45] 0 0
Ukraine
State/province [45] 0 0
Zaporizhzhya
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galapagos NV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03201445