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 -

SLCTR Registration Number

SLCTR/2018/023


Date of Registration

01 Aug 2018

The date of last modification

Aug 01, 2018



Application Summary


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 of 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)


Trial Details


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


Purpose

Phase 2


Intervention(s) planned

• Study site is Colombo North Teaching Hospital, Ragama

• Subjects will be randomized to two arms

  • Active arm treated with filgotinib
  • Control arm treated with placebo (This is a tablet without active ingredient filgotinib).

• 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

  1. Aged between 25 and 55 years (inclusive) on the day of signing informed consent

  2. Documented diagnosis of UC for at least 4 months and with a minimum disease extent of 15 cm from the anal verge

  3. Having endoscopic and histopathologic evidence of UC

  4. Having moderate to severe active UC


Exclusion criteria

  1. Previously documented problems with male reproductive health including (but not limited to),
    • known hypothalamic-pituitary disorders (eg, pituitary macroadenomas, pituitary infarction, hyperprolactinemia, panhypopituitarism),
  2. primary hypogonadism (eg, cryptorchidism, Klinefelter’s syndrome)

  3. Prior diagnosis of male infertility

  4. Presence of,

    • Crohn's disease (CD)
    • Indeterminate colitis
    • Ischemic colitis,
    • Fulminant colitis
    • Isolated ulcerative proctitis
    • Toxic mega-colon
  5. Active tuberculosis (TB) or history of latent TB that has not been treated

  6. Use of concomitant prohibited medications as outlined by protocol section 5.3.2



Primary outcome(s)

Proportion of participants with a >50% decrease in sperm concentration compared to baseline


Primary outcome(s) - Time of assessment(s)

At 13 weeks after initiating the intervention


Secondary outcome

  1. The proportion of subjects with a >50% decrease from baseline in sperm concentration

  2. Change from baseline in percent motile sperm

  3. Change from baseline in total sperm count

  4. Change from baseline in sperm concentration

  5. Change from baseline in ejaculate volume

  6. Change from baseline in percent normal sperm morphology


Secondary outcome(s) - Time of assessment(s)

  • Proportion of participants with a >50% decrease in sperm concentration compared to baseline will be measured at 26 weeks form initiating the intervention

  • All other parameters will be measured at 13 and 26 weeks of initiating the intervention



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


Recruitment status

Pending


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 13 March 2018 (Ref:P/285/12/2017)


Funding source

Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404, USA



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None