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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/023

Enrollment

Unknown

Registered

2018-08-01

Start date

2018-07-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

• 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 with

Eligibility

Inclusion criteria

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

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), - primary hypogonadism (eg, cryptorchidism, Klinefelter’s syndrome) 2. Prior diagnosis of male infertility 3. Presence of, - Crohn's disease (CD) - Indeterminate colitis - Ischemic colitis, - Fulminant colitis - Isolated ulcerative proctitis - Toxic mega-colon 4. Active tuberculosis (TB) or history of latent TB that has not been treated 5. Use of concomitant prohibited medications as outlined by protocol section 5.3.2

Design outcomes

Primary

Measure	Time frame
Proportion of participants with a >50% decrease in sperm concentration compared to baseline [At 13 weeks after initiating the intervention]	—

Secondary

Measure	Time frame
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 [- 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]	—

Measure

Time frame

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 [- 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]

—

Countries

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 Stat

Contacts

Public ContactProf Arjuna de Silva

Consultant Physician

apdesilva@kln.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026