Inflammatory Bowel DiseasePhase 2MANTANCT03201445
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
A Phase 2 study testing Filgotinib in people with Inflammatory Bowel Disease, run by Lakefront Biotherapeutics NV at 56 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 56 sitesin 11 countries
- Study dates
- 11 Jul 2017to 24 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
56 sites in 11 countries.
56 sites in 11 countries
India23 sites
Kaizen Hospital
Ahmedabad, 380052
SP Medical college & AG Hospitals
Bīkaner, 334001
Maharaja Agrasen Hospital
Dehli, 110026
Nizam's Institute of Medical Sciences
Hyderabad, 500082
SR Kalla Memorial Gastro and General Hospital
Jaipur, 302001
SMS Medical College and Hospital
Jaipur, 302004
Om Sai Onco Surgery Center
Kolhāpur, 416006
Institute of Post Graduate Medical Education and Research (IPGMER)
Kolkata, 700020
Radha Krishna Critical Care & General Hospital
Kota, 324005
Dayanand Medical College & Hospital
Ludhiana, 141001
Rahate Surgical Hospital
Nagpur, 440008
Crescent Hospital and Heart Centre
Nagpur, 440012
All India Institute of Medical Sciences
New Delhi, 110029
Sir Ganga Ram Hospital
New Delhi, 110060
Batra Hospital and Medical Research Center
New Delhi, 110062
Seth GS medical college and KEM hospital
Parel, Mumbai, 400012
Shri Griraj Multispeciality Hospital
Rajkot, 360005
Gandhi Hospital
Secunderabad, 500003
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
Secunderabad, 50003
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002
BAPS Pramukh Swami Hospital
Surat, 395009
Sterling Hospital
Vadodara, 390007
Samvedna Hospital
Varanasi, 221005
United States10 sites
Texas Clinical Research Institute
Arlington, Texas, 76012
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Gastro One
Germantown, Tennessee, 38138
Florida Research Institute
Lakewood Rch, Florida, 34211
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
Delta Research Partners
Monroe, Louisiana, 71201
One Health Research Clinic, Inc
Norcross, Georgia, 30093
Naval Medical Center San Diego
San Diego, California, 92134
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Ukraine8 sites
Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
Kharkiv, 61137
Kyiv City Clinical Hospital #18, Proctology Department
Kiev, 01030
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
Vinnitsa, 21018
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
Vinnitsya, 21018
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
Vinnitsya, 21029
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
Vinnytsia, 21018
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
Zaporizhzhya, 69096
Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
Zaporizhzhya, 69600
Poland5 sites
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
Bydgoszcz, 85-079
Krakowskie Centrum Medyczne
Krakow, 31-501
Santa Familia, Centrum Badan Profilaktyki i Leczenia
Lodz, 90-302
Endoskopia Sp.z o.o
Sopot, 81-756
Bodyclinic Alicja Pasnik
Warsaw, 00-332
Russia4 sites
Olla-Med, Llc
Moscow, 105554
State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
Penza, 440026
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
Rostov-on-Don, 344022
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
Saint Petersburg, 196247
Austria1 site
AKH Wien - Universitatsklinik fur Innere Medizin III
Vienna, 1090
Romania1 site
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
Timișoara, 300594
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
About this study
Official 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
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.
Read the detailed description
There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Filgotinib, Placebo, Standard of Care
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
200 mg tablet administered orally once daily
PlaceboDrug
Placebo to match filgotinib tablet administered orally once daily
Standard of CareDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Experimental | 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. Receives: Drug: Filgotinib; Drug: Standard of Care |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
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.
Measured: Baseline to Week 13
Secondary outcomes (11)
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
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.
Measured: Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 13
The normal range for sperm total motility is ≥40%.
Measured: Baseline, Week 13
Change From Baseline in Sperm Total Motility at Week 26
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%.
Measured: Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
The normal range for total sperm count is ≥ 39 million sperm cells/ejaculate.
Measured: Baseline, Week 13
Change From Baseline in Total Sperm Count at Week 26
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.
Measured: Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
The normal range for sperm concentration is ≥15 million sperm cells/mL.
Measured: Baseline, Week 13
Change From Baseline in Sperm Concentration at Week 26
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.
Measured: Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 13
The normal range for ejaculate volume is ≥1.5 mL.
Measured: Baseline, Week 13
Change From Baseline in Ejaculate Volume at Week 26
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.
Measured: Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 13
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Measured: Baseline, Week 13
Change From Baseline in Percent Normal Sperm Morphology at Week 26
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.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start11 Jul 2017
- Primary completion20 Nov 2020
- Study completion24 Oct 2023
Why it stopped: Early Termination for Reasons other than Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201445
- Sponsor's protocol ID
- GS-US-418-4279
- Other IDs
- 2017-000402-38, 2017
- Acronym
- MANTA
- Status last verified
- Oct 2024
- First submitted
- 26 Jun 2017
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.
PubMed 37137672Hellstrom 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.
PubMed 35614292
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03201445
- Acronym / sponsor ID
- MANTA / GS-US-418-4279
- Conditions
- Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early Termination for Reasons other than Safety
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: Filgotinib, Drug: Standard of CareParticipants 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 | Placebo comparator | Drug: Placebo, Drug: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filgotinib200 mg tablet administered orally once daily | Drug | Filgotinib |
| PlaceboPlacebo to match filgotinib tablet administered orally once daily | Drug | Placebo |
| Standard of CareLocally approved treatment, accepted by medical experts as a proper treatment for IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity. | Drug | Filgotinib, Placebo |
Primary outcome
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Time frame: Baseline to Week 13
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.
11 secondary outcomes
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Time frame: Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Sperm Total Motility at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Total Sperm Count at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Sperm Concentration at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Ejaculate Volume at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37137672Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.
- Derived from this study: PubMed 35614292Hellstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galapagos Study Director study director
Lakefront Biotherapeutics NV
56 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgotinib in people with Inflammatory Bowel Disease, run by Lakefront Biotherapeutics NV at 56 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in India, United States, Ukraine, Poland, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 (time frame: Baseline to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.