Trial · NCT01658605
A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis
NCT01658605, Phase 2, Withdrawn, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis. Trials, record NCT01658605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01658605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis
- NCT number
- NCT01658605
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Colitis, Ulcerative
- Interventions
- GSK1605786, Placebo
- First posted
- 2012-08-07
- Last updated
- 2013-06-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of GSK1605786 at week 12 following twice daily administration at 500 mg in patients with active UC. | 12 weeks | Ordinal response (remission, response, or no response) to treatment as assessed by the MAYO score at week 12. |
| Secondary | safety and tolerability of GSK1605786 in patients with active UC following repeat dosing continued for up to 16 weeks | 16 weeks | Adverse events (AEs), Treatment effects on blood pressure, heart rate, electrocardiography (ECG) parameters and haematology, clinical chemistry and urinalysis findings |
| Secondary | The time course of the efficacy of GSK1605786 | 16 Weeks | Incidence of remission (MAYO score ≤ 2 with no individual subscale exceeding 1) at Week 12, incidence of response (MAYO score decreased for ≥ 3 points in comparison with baseline) at Week 12, change in partial MAYO score compared to baseline through week 16, change in SCCAI score compared to baseline through week 16, incidence of endoscopic remission (mucosal healing) rate at Week 12 (defined as proportion of patients with endoscopy score of 0 or 1 on the MAYO endoscopic sub-scale) and time to withdrawal and/or use of rescue medication |
| Secondary | The anti-inflammatory activity of GSK1605786 in patients with active UC | 16 Weeks | Circulating soluble biomarkers (CRP, CXL10), faecal calprotectin levels, receptor occupancy (CCR9 internalization). |
| Secondary | The effects of GSK1605786 on quality of life in patients with UC | Baseline, week 12, week 16 | Quality of Life (IBDQ) Questionnaire. |
| Secondary | The systemic pharmacokinetics (PK) of GSK1605786 following twice daily administration at 500 mg in patients with active UC. | DaysBaseline, week 4, week 8, week 12, week 16 | The maximum observed concentration (Cmax) on Day 28; Trough concentration (Cτ) on Day 28; Plasma clearance and volume of distribution estimated based on population pharmacokinetic analysis of healthy volunteers (historical data) and patient data, if possible |
| Secondary | CCR9 occupancy (RO) in peripheral blood | 12 Weeks | TECK/CCL25 and CCR9 expression in colon biopsy at baseline and at 12 weeks |
Source ClinicalTrials.gov
Outcomes0
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/NCT01658605
GET https://conductscience.org/api/trials/v1/NCT01658605/registered