Home » Trials » SLCTR/2018/023
A randomized, double-blind, placebo-controlled phase 2 study to evaluate the testicular safety of filgotinib in adult males with moderate to severe active ulcerative colitis
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SLCTR Registration Number
SLCTR/2018/023
Date of Registration
The date of last modification
Oct 02, 2020
Scientific Title of Trial
A randomized, double-blind, placebo-controlled phase 2 study to evaluate the testicular safety of filgotinib in adult males with moderate to severe active ulcerative colitis
Public Title of Trial
A randomized, double-blind, placebo-controlled phase 2 study to evaluate the testicular safety of filgotinib in adult males with moderate to severe active ulcerative colitis
Disease or Health Condition(s) Studied
Ulcerative Colitis
Scientific Acronym
None
Public Acronym
None
Brief title
Study to evaluate the testicular safety of filgotinib in adult males with moderate to severe active ulcerative colitis
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
NCT03201445; Clinical trials.gov Ref:P/285/12/2017 (ERC:Kelaniya)
What is the research question being addressed?
What is the effect of filgotinib on testicular safety in adult males with moderate to severe active ulcerative colitis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
• Study site is Colombo North Teaching Hospital, Ragama
• Subjects will be randomized to two arms
• Investigational product [Active Filgotinib/Placebo (tablet without filgotinib)] is a 200mg tablet and is to be administered orally by subject once daily.
• Subject will be evaluated every 13 weeks for ulcerative colitis based on the partial Mayo Clinic score.
• During week 13 if the subject is not responding to the blinded investigational product, treatment will be un-blinded and patient will be switched to open label active Filgotinib treatment.
• During week 26 onwards if the subject is not responding to the blinded Investigational product (Filgotinib/Placebo) subject will be offered the option to enter the Long Term Extension phase of the study and will receive open label active Filgotinib.
• Subjects adequately responding (as per Mayo score evaluation) to the treatment of ulcerative colitis (UC) will continue to be treated with filgotinib/ placebo.
• If worsening of disease is observed, subject will be withdrawn from the study.
• Semen analysis is to be performed in subjects every 13 weeks. The subject will continue to administer Filgotinib/Placebo until 50% decrease in sperm concentration is observed compared to baseline value.
• Subject will be withdrawn from the study if >50% decrease of sperm concentration is observed and will be followed up during the monitoring phase till reversibility in sperm concentration is observed
• Subject in both arms are allowed to continue with the following standard management, provided the subjects are on stable doses of treatment. The dose of the below medications should be same once the subject is enrolled in the study untill the subject starts taking the study drug. - 5-aminosalicylate (5-ASA) except sulfasalazine - Azathioprine, 6-MP ( Mercaptopurine), or MTX (methotrexate) - Corticosteroid therapy (prednisone prescribed at a stable dose <20 mg/day or budesonide prescribed at a stable dose of <9 mg/day)
Inclusion criteria
Aged between 25 and 55 years (inclusive) on the day of signing informed consent
Documented diagnosis of UC for at least 4 months and with a minimum disease extent of 15 cm from the anal verge
Having endoscopic and histopathologic evidence of UC
Having moderate to severe active UC
Exclusion criteria
primary hypogonadism (eg, cryptorchidism, Klinefelter’s syndrome)
Prior diagnosis of male infertility
Presence of,
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of concomitant prohibited medications as outlined by protocol section 5.3.2
Primary outcome(s)
1.
Proportion of participants with a >50% decrease in sperm concentration compared to baseline |
[ At 13 weeks after initiating the intervention ] |
Secondary outcome(s)
1.
|
[
|
Target number/sample size
12 (6 in each arm)
Countries of recruitment
Australia, Austria, Belgium, Canada, Czech Republic, Germany, Hungary, India, Italy, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Sri Lanka, Sweden, Ukraine, United Kingdom, United States
Anticipated start date
2018-07-10
Anticipated end date
2019-12-31
Date of first enrollment
Date of study completion
Recruitment status
Suspended
Funding source
Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404, USA
Regulatory approvals
NMRA/SCOCT/P4/CTM/008/2017
Status
Approved
Date of Approval
2018-03-13
Approval number
P/285/12/2017
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof Arjuna de Silva
Consultant Physician
Ward No. 22, Professorial medical unit, Colombo North Teaching Hospital, Ragama-11010, Sri Lanka
+ 94-777572379
apdesilva@kln.ac.lk
Contact Person for Public Queries
Prof Arjuna de Silva
Consultant Physician
Ward No. 22, Professorial medical unit, Colombo North Teaching Hospital, Ragama-11010, Sri Lanka
+ 94-777572379
apdesilva@kln.ac.lk
Primary study sponsor/organization
Gilead Sciences, Inc
Gilead Clinical Study Information Center
333 Lakeside Drive
Foster City, CA 94404, USA
+1-833-445-3230
GileadClinicalTrials@gilead.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results