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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
Date last updated
9/10/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT03201445
Trial related presentations / publications
Hellstrom WJG, Dolhain RJEM, Ritter TE, Watkins TR, Arterburn SJ, Dekkers G, Gillen A, Tonussi C, Gilles L, Oortwijn A, Van Beneden K, de Vries DE, Sikka SC, Vanderschueren D, Reinisch W. MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases. Adv Ther. 2022 Jul;39(7):3403-3422. doi: 10.1007/s12325-022-02168-4. Epub 2022 May 25.
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



Summary Results

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