GLPG3970
DrugGLPG3970 powder and solvent for oral solution reconstituted prior to use.
NCT Number: NCT04577794
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.
Looking for future studies?
Notify Me18 year–64 year
All sexes
Interventional
Phase 2
Arensia Exploratory Medicine LLC, Tbilisi, Georgia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
GLPG3970 powder and solvent for oral solution reconstituted prior to use.
Placebo powder and solvent for oral solution reconstituted prior to use.
Time frame: Baseline and 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: First dose date up to 14 days after the last dose of study drug (up to 57 days)
Treatment-Emergent Adverse Events (TEAEs) were defined as
Serious TEAE was defined as a TEAE that
Time frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
Ctrough was defined as plasma concentration level at the end of the dosing interval.
Lakefront Biotherapeutics NV
Industry
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym: SEA TURTLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02647866
Abdominal Pain, Autoimmune Disease
Greenville, South Carolina, United States
View Trial DetailsNCT00065065
Colitis, Colitis, Ulcerative
Atlanta, Georgia, United States
View Trial DetailsNCT06598943
Colitis, Colitis, Ulcerative
Chandler, Arizona, United States
View Trial DetailsNCT07513181
Autoimmune Diseases, Colitis
Miami, Florida, United States
View Trial Details