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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03201445
Ethics application status
Date submitted
26/06/2017
Date registered
28/06/2017
Date last updated
10/07/2020

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: Part A and Part B (Filgotinib or Placebo) - Participants will receive double-blind filgotinib or placebo for 13 weeks in Part A. Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks in Part B or discontinue blinded study drug and commence open-label filgotinib.

Experimental: Open-Label Filgotinib Phase - Participants will receive open-label filgotinib for up to 13 weeks.

Experimental: Monitoring Phase - Participants whose sperm parameters meet a pre- specified decrease threshold at any time during the study, regardless of inflammatory bowel disease response status, will discontinue study drug and receive standard of care therapy in the Monitoring Phase.

Experimental: Long Term Extension Phase - Participants qualifying to enter the Long Term Extension Phase will receive either open-label filgotinib or blinded study drug for up to 195 weeks based on the individual's response criteria.


Treatment: Drugs: Filgotinib
200 mg tablet administered orally once daily

Treatment: Drugs: Placebo
Tablet administered orally once daily

Treatment: Drugs: Standard of Care
Standard of care therapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
Key

- Male participants who are between the ages of 21 and 65 (inclusive) on the day of
signing informed consent

- 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Cambridge
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Exeter

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

Ethics approval
Ethics application status

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.

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.
Trial website
https://clinicaltrials.gov/show/NCT03201445
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03201445