Trial · NCT01829321
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
NCT01829321, Phase 2, Completed, Lakefront Biotherapeutics NV
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis. Trials, record NCT01829321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01829321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
- NCT number
- NCT01829321
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Ulcerative Colitis
- Interventions
- GLPG0974, Placebo
- First posted
- 2013-04-11
- Last updated
- 2014-04-25
- Other registries' IDs
- eudract:2012-005521-73
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of adverse events | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported |
| Primary | Changes in physical exam measures | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported |
| Primary | Changes in vital signs as measured by heart rate, blood pressure and oral temperature | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported |
| Primary | Changes in 12-lead ECG measures | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported |
| Primary | Changes in blood safety lab parameters | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported |
| Primary | Changes in urine safety lab parameters | Screening up to Follow up (14 days after last dosing) | To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported |
| Secondary | Changes in (partial) Mayo clinical disease activity score | From Day 1 to Day 29 | To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported |
| Secondary | Changes in histopathological clinical activity score in colon biopsies | Day 1 and Day 29 | To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported |
| Secondary | The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 | Day 8, Day 15 and Day 29 | To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients |
| Secondary | Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974 | Screening up to Day 29 | To evaluate the changes in the levels of calprotectin in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01829321
GET https://conductscience.org/api/trials/v1/NCT01829321/registered