search
Back to results

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease (MANTA)

Primary Purpose

Inflammatory Bowel Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgotinib
Placebo
Standard of Care
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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 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

Sites / Locations

  • Naval Medical Center San Diego
  • Florida Research Institute
  • University of Miami Crohn's and Colitis Center
  • One Health Research Clinic, Inc
  • Delta Research Partners
  • Clinical Research Institute of Michigan, LLC
  • Great Lakes Gastroenterology Research, LLC
  • Gastro One
  • Texas Clinical Research Institute
  • Texas Digestive Disease Consultants
  • Monash Medical Centre
  • AKH Wien - Universitatsklinik fur Innere Medizin III
  • Medizinische Hochschule Hannover
  • Surat Institute of Digestive Sciences
  • Seth GS medical college and KEM hospital
  • Kaizen Hospital
  • SP Medical college & AG Hospitals
  • Maharaja Agrasen Hospital
  • Nizam's Institute of Medical Sciences
  • SR Kalla Memorial Gastro and General Hospital
  • SMS Medical College and Hospital
  • Om Sai Onco Surgery Center
  • Institute of Post Graduate Medical Education and Research (IPGMER)
  • Radha Krishna Critical Care & General Hospital
  • Dayanand Medical College & Hospital
  • Rahate Surgical Hospital
  • Crescent Hospital and Heart Centre
  • All India Institute of Medical Sciences
  • Sir Ganga Ram Hospital
  • Batra Hospital and Medical Research Center
  • Shri Griraj Multispeciality Hospital
  • Gandhi Hospital
  • Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
  • BAPS Pramukh Swami Hospital
  • Sterling Hospital
  • Samvedna Hospital
  • Wellington Hospital
  • Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
  • Krakowskie Centrum Medyczne
  • Endoskopia Sp.z o.o
  • Bodyclinic Alicja Pasnik
  • Santa Familia, Centrum Badan Profilaktyki i Leczenia
  • S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
  • Olla-Med, Llc
  • State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
  • State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
  • Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
  • Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
  • Kyiv City Clinical Hospital #18, Proctology Department
  • Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
  • Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
  • Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
  • Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
  • Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
  • Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
  • Cambridge University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A (Filgotinib or Placebo)

Part B (Filgotinib or Placebo)

Open-Label Filgotinib Phase

Monitoring Phase

Long Term Extension Phase

Arm Description

Participants will receive double-blind filgotinib or placebo for 13 weeks

Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks or discontinue blinded study drug and commence open-label filgotinib.

Participants will receive open-label filgotinib for up to 13 weeks.

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.

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.

Outcomes

Primary Outcome Measures

Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13

Secondary Outcome Measures

Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Change From Baseline in Percent Motile Sperm at Week 13
Change From Baseline in Percent Motile Sperm at Week 26
Change From Baseline in Total Sperm Count at Week 13
Change From Baseline in Total Sperm Count at Week 26
Change From Baseline in Sperm Concentration at Week 13
Change From Baseline in Sperm Concentration at Week 26
Change from Baseline in Ejaculate Volume at Week 13
Change from Baseline in Ejaculate Volume at Week 26
Change from Baseline in Percent Normal Sperm Morphology at Week 13
Change from Baseline in Percent Normal Sperm Morphology at Week 26

Full Information

First Posted
June 26, 2017
Last Updated
October 11, 2022
Sponsor
Galapagos NV
Collaborators
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03201445
Brief Title
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Acronym
MANTA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A (Filgotinib or Placebo)
Arm Type
Experimental
Arm Description
Participants will receive double-blind filgotinib or placebo for 13 weeks
Arm Title
Part B (Filgotinib or Placebo)
Arm Type
Experimental
Arm Description
Based on inflammatory bowel disease response status and sperm parameters, participants will continue on the blinded treatment for up to an additional 13 weeks or discontinue blinded study drug and commence open-label filgotinib.
Arm Title
Open-Label Filgotinib Phase
Arm Type
Experimental
Arm Description
Participants will receive open-label filgotinib for up to 13 weeks.
Arm Title
Monitoring Phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Long Term Extension Phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Intervention Description
200 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care therapy options may include but are not limited to methotrexate
Primary Outcome Measure Information:
Title
Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Time Frame
Week 13
Secondary Outcome Measure Information:
Title
Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Time Frame
Week 26
Title
Change From Baseline in Percent Motile Sperm at Week 13
Time Frame
Week 13
Title
Change From Baseline in Percent Motile Sperm at Week 26
Time Frame
Week 26
Title
Change From Baseline in Total Sperm Count at Week 13
Time Frame
Week 13
Title
Change From Baseline in Total Sperm Count at Week 26
Time Frame
Week 26
Title
Change From Baseline in Sperm Concentration at Week 13
Time Frame
Week 13
Title
Change From Baseline in Sperm Concentration at Week 26
Time Frame
Week 26
Title
Change from Baseline in Ejaculate Volume at Week 13
Time Frame
Week 13
Title
Change from Baseline in Ejaculate Volume at Week 26
Time Frame
Week 26
Title
Change from Baseline in Percent Normal Sperm Morphology at Week 13
Time Frame
Week 13
Title
Change from Baseline in Percent Normal Sperm Morphology at Week 26
Time Frame
Week 26

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
University of Miami Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
One Health Research Clinic, Inc
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
AKH Wien - Universitatsklinik fur Innere Medizin III
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Surat Institute of Digestive Sciences
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Seth GS medical college and KEM hospital
City
Parel
State/Province
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Kaizen Hospital
City
Ahmedabad
ZIP/Postal Code
380052
Country
India
Facility Name
SP Medical college & AG Hospitals
City
Bīkaner
ZIP/Postal Code
334001
Country
India
Facility Name
Maharaja Agrasen Hospital
City
Dehli
ZIP/Postal Code
110026
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
SR Kalla Memorial Gastro and General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
SMS Medical College and Hospital
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Om Sai Onco Surgery Center
City
Kolhapur
ZIP/Postal Code
416006
Country
India
Facility Name
Institute of Post Graduate Medical Education and Research (IPGMER)
City
Kolkata
ZIP/Postal Code
700020
Country
India
Facility Name
Radha Krishna Critical Care & General Hospital
City
Kota
ZIP/Postal Code
324005
Country
India
Facility Name
Dayanand Medical College & Hospital
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Rahate Surgical Hospital
City
Nagpur
ZIP/Postal Code
440008
Country
India
Facility Name
Crescent Hospital and Heart Centre
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Batra Hospital and Medical Research Center
City
New Delhi
ZIP/Postal Code
110062
Country
India
Facility Name
Shri Griraj Multispeciality Hospital
City
Rajkot
ZIP/Postal Code
360005
Country
India
Facility Name
Gandhi Hospital
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Facility Name
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
City
Secunderabad
ZIP/Postal Code
50003
Country
India
Facility Name
BAPS Pramukh Swami Hospital
City
Surat
ZIP/Postal Code
395009
Country
India
Facility Name
Sterling Hospital
City
Vadodara
ZIP/Postal Code
390007
Country
India
Facility Name
Samvedna Hospital
City
Varanasi
ZIP/Postal Code
221005
Country
India
Facility Name
Wellington Hospital
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Endoskopia Sp.z o.o
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Bodyclinic Alicja Pasnik
City
Warsaw
ZIP/Postal Code
00-332
Country
Poland
Facility Name
Santa Familia, Centrum Badan Profilaktyki i Leczenia
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie
City
Timisoara
ZIP/Postal Code
300594
Country
Romania
Facility Name
Olla-Med, Llc
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1
City
Kharkiv
ZIP/Postal Code
61137
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #18, Proctology Department
City
Kiev
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department
City
Vinnitsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Medical Center LLC "Health Clinic", Medical Clinical Investigational Center
City
Vinnitsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,
City
Zaporizhzhya
ZIP/Postal Code
69096
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35614292
Citation
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.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

We'll reach out to this number within 24 hrs