The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately to severely active UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Arensia Exploratory Medicine LLC
Tbilisi, Georgia
ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
Change From Baseline in Total MCS at Week 6
The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation.
Time frame: Baseline and Week 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-Emergent Adverse Events (TEAEs) were defined as * Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date. * Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent. Serious TEAE was defined as a TEAE that * Resulted in death and was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly / birth defect; * Was medically significant.
Time frame: First dose date up to 14 days after the last dose of study drug (up to 57 days)
Plasma Concentration (Ctrough) of GLPG3970
Ctrough was defined as plasma concentration level at the end of the dosing interval.
Time frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centrum Medyczne PROMED
Krakow, Poland
Endoskopia Sp. z o.o.
Sopot, Poland
ETG Zamosc
Zamość, Poland
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, Ukraine
Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini
Kherson, Ukraine
...and 5 more locations