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

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03201445
• Collaborator: Galapagos NV (Industry)
• Enrollment: 139
• Locations: 56
• Arms: 5
• Anticipated Duration (Months): 84.7
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Drug: Filgotinib; Drug: Placebo; Drug: Standard of Care	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 11, 2017
• Actual Primary Completion Date: Jul 31, 2020
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A (Filgotinib or Placebo) Participants will receive double-blind filgotinib or placebo for 13 weeks	Drug: Filgotinib; 200 mg tablet administered orally once daily; Drug: Placebo; Tablet administered orally once daily
Experimental: Part B (Filgotinib or Placebo) 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.	Drug: Filgotinib; 200 mg tablet administered orally once daily; Drug: Placebo; Tablet administered orally once daily
Experimental: Open-Label Filgotinib Phase Participants will receive open-label filgotinib for up to 13 weeks.	Drug: Filgotinib; 200 mg tablet administered orally once daily
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.	Drug: Standard of Care; Standard of care therapy options may include but are not limited to methotrexate
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.	Drug: Filgotinib; 200 mg tablet administered orally once daily; Drug: Placebo; Tablet administered orally once daily

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Proportion of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 [Week 26]

2. Change From Baseline in Percent Motile Sperm at Week 13 [Week 13]

3. Change From Baseline in Percent Motile Sperm at Week 26 [Week 26]

4. Change From Baseline in Total Sperm Count at Week 13 [Week 13]

5. Change From Baseline in Total Sperm Count at Week 26 [Week 26]

6. Change From Baseline in Sperm Concentration at Week 13 [Week 13]

7. Change From Baseline in Sperm Concentration at Week 26 [Week 26]

8. Change from Baseline in Ejaculate Volume at Week 13 [Week 13]

9. Change from Baseline in Ejaculate Volume at Week 26 [Week 26]

10. Change from Baseline in Percent Normal Sperm Morphology at Week 13 [Week 13]

11. Change from Baseline in Percent Normal Sperm Morphology at Week 26 [Week 26]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center San Diego	San Diego	California	United States	92134
2	Florida Research Institute	Lakewood Ranch	Florida	United States	34211
3	University of Miami Crohn's and Colitis Center	Miami	Florida	United States	33136
4	One Health Research Clinic, Inc	Norcross	Georgia	United States	30093
5	Delta Research Partners	Monroe	Louisiana	United States	71201
6	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
7	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	United States	44060
8	Gastro One	Germantown	Tennessee	United States	38138
9	Texas Clinical Research Institute	Arlington	Texas	United States	76012
10	Texas Digestive Disease Consultants	Southlake	Texas	United States	76092
11	Monash Medical Centre	Clayton	Victoria	Australia	3168
12	AKH Wien - Universitatsklinik fur Innere Medizin III	Vienna		Austria	1090
13	Medizinische Hochschule Hannover	Hannover		Germany	30625
14	Surat Institute of Digestive Sciences	Surat	Gujarat	India	395002
15	Seth GS medical college and KEM hospital	Parel	Mumbai	India	400012
16	Kaizen Hospital	Ahmedabad		India	380052
17	SP Medical college & AG Hospitals	Bīkaner		India	334001
18	Maharaja Agrasen Hospital	Dehli		India	110026
19	Nizam's Institute of Medical Sciences	Hyderabad		India	500082
20	SR Kalla Memorial Gastro and General Hospital	Jaipur		India	302001
21	SMS Medical College and Hospital	Jaipur		India	302004
22	Om Sai Onco Surgery Center	Kolhapur		India	416006
23	Institute of Post Graduate Medical Education and Research (IPGMER)	Kolkata		India	700020
24	Radha Krishna Critical Care & General Hospital	Kota		India	324005
25	Dayanand Medical College & Hospital	Ludhiana		India	141001
26	Rahate Surgical Hospital	Nagpur		India	440008
27	Crescent Hospital and Heart Centre	Nagpur		India	440012
28	All India Institute of Medical Sciences	New Delhi		India	110029
29	Sir Ganga Ram Hospital	New Delhi		India	110060
30	Batra Hospital and Medical Research Center	New Delhi		India	110062
31	Shri Griraj Multispeciality Hospital	Rajkot		India	360005
32	Gandhi Hospital	Secunderabad		India	500003
33	Institute of Gastroenterology & Liver Disease, Sunshine Hospitals	Secunderabad		India	50003
34	BAPS Pramukh Swami Hospital	Surat		India	395009
35	Sterling Hospital	Vadodara		India	390007
36	Samvedna Hospital	Varanasi		India	221005
37	Wellington Hospital	Newtown		New Zealand	6021
38	Osrodek Badan Klinicznych Cinsante S.C Ewa Galczak-Nowak	Bydgoszcz		Poland	85-079
39	Krakowskie Centrum Medyczne	Kraków		Poland	31-501
40	Endoskopia Sp.z o.o	Sopot		Poland	81-756
41	Bodyclinic Alicja Pasnik	Warsaw		Poland	00-332
42	Santa Familia, Centrum Badan Profilaktyki i Leczenia	Łódź		Poland	90-302
43	S.C. Policlinica Dr. Citu S.R.L - Gastroenterologie	Timisoara		Romania	300594
44	Olla-Med, Llc	Moscow		Russian Federation	105554
45	State Budgetary Healthcare Institution, Pensa Regional Clinical Hospital n.a N.N Burdenko	Penza		Russian Federation	440026
46	State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Health of Russian Fedn.	Rostov-on-Don		Russian Federation	344022
47	Saint Petersburg State Budgetary Healthcare Institution "City Hospital # 26"	Saint Petersburg		Russian Federation	196247
48	Municipal Health Care Institution "Regional Hospital of War Veterans", Therapeutic Department No. 1	Kharkiv		Ukraine	61137
49	Kyiv City Clinical Hospital #18, Proctology Department	Kiev		Ukraine	01030
50	Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No. 2	Vinnitsa		Ukraine	21018
51	Vinnytsia Regional Clinical Hospital named after M.I. Pirogov, Gastroenterology Department	Vinnitsya		Ukraine	21018
52	Medical Center LLC "Health Clinic", Medical Clinical Investigational Center	Vinnitsya		Ukraine	21029
53	Vinnytsia Regional Clinical Hospital of War Veterans, Therapeutics Department No.1	Vinnytsya		Ukraine	21018
54	Municupal Institution "Zaporizhzhia City Multidisciplinary Clinic #9" Gastrointestinal Surgery Department,	Zaporizhzhya		Ukraine	69096
55	Municipal Non-profit Enterprise "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,	Zaporizhzhya		Ukraine	69600
56	Cambridge University Hospitals NHS Foundation Trust	Cambridge		United Kingdom	CB2 0QQ

Sponsors and Collaborators

• Gilead Sciences
• Galapagos NV

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT03201445
• Other Study ID Numbers: GS-US-418-4279; 2017-000402-38
• First Posted: Jun 28, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

No Results Posted as of Mar 31, 2022