Colitis, UlcerativePhase 2NCT00748410
Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis
A Phase 2 study testing SB-656933 in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- SB-656933
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2009to 12 Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A history of ulcerative colitis for at least 3 months
- moderately active UC, either stable on medications or in a flare of the disease
- Mayo endoscopic score of 2 or 3 within 2 days of dosing.
- Male or female between 18 and 65 years of age
- Women of child bearing potential must use an effective method of contraception.
- Male subjects must agree to use one of the specified contraception method,
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal at study start.
- Signed written informed consent
- QTcB or QTcF < 450msec at screening
Who cannot join
- The subject has a positive pre-study drug/alcohol screen.
- A positive test for HIV, hepatitis B or C.
- History of regular alcohol consumption within 6 months of the study
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication
- Known allergies
- recent participation in another trial
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- recent blood donation
- Pregnant or lactating females
- unwillingness or inability to follow study procedures
- consumption of red wine, seville oranges, grapefruit or grapefruit juice in last 7 seven day before study start.
- Mild UC, Mayo endoscopic score of 0 or 1.
- Toxic megacolon or perforation on plain abdominal Xray.
- Crohn's Disease, indeterminate colitis, bleeding disorders, or active ulcer disease.
- Previous colonic surgery.
- Current or recurrent disease, other than UC, that could affect the action, absorption or disposition of the study medication, or clinical or laboratory assessments.
- Absolute neutrophil count below 2.0x109/L.
- A positive culture for enteric pathogens that is clinically significant, presence of clostridium difficile toxin, or with ova and parasites detected by microscopy, or has a clinical suspicion of an infectious disease of the bowel.
- Symptomatic GI stricture within 6 months of screening or obstructive symptoms within 3 months of screening.
- Likely to require abdominal surgery within the study period.
- Congenital or acquired immunodeficiency, including any immunologic diseases with gastrointestinal involvement except for UC.
- Ongoing neoplastic disease of the bowel.
- History of prostatitis, epididymitis, epididymal cysts, structural abnormalities or testicular cancer.
- Subjects with abnormalities of the renal tract, renal stones or history of recurrent urinary tract infections (UTI.s).
- Subjects with any history of autoimmune hepatitis or sclerosing cholangitis. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
- Blood pressure persistently ≥ 140/90 mmHg at screening
- Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, pulmonary, hepatic, endocrine, metabolic, haematological, or neurological condition).
- Clinically significant hepatic impairment(Evidence of cirrhosis, Clinical episodes of jaundice)
- Current evidence of, or has been treated for a malignancy within the past 5 years.
- BMI <18 kg.m2 or >35 kg/m2
- Clinically significant renal laboratory values.
- Has not discontinued any prohibited concomitant medication prior to the screening visit or within the protocol-specified time period.
- Has not remained on a stable dose of any permitted concomitant medication(s) for the protocol-specified time period preceding the Screening Visit.
- history of substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis.
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.
- Conditions
- Colitis, Ulcerative
- Being tested
- SB-656933
- Keywords
- CD11b, Ulcerative colitis, 99mTc-HMPAO-labelled leukocyte scintigraphy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-656933Drug
Also called SB656933
7 days repeat dose
| Study group | Role | What they receive |
|---|---|---|
| 7 Days Repeat Dose | Experimental | Not described Receives: Drug: SB-656933 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
Measured: Baseline (Day -1) and Day 1 and 7
Secondary outcomes (5)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to follow-up (7 to 10 days after last dose)
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Measured: Day 1 and 7
Vital Signs Assessment- Heart Rate
Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Measured: Day 1 and 7
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
Measured: Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7
Amount of Medicine in Blood
Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.
Measured: At 1, 2.25, 4, 8 hour on Day 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study start22 Jan 2009
- Primary completion12 Dec 2009
- Study completion12 Dec 2009
Why it stopped: SB-656933 is no longer being developed for ulcerative colitis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748410
- Sponsor's protocol ID
- CUC111342
- Other IDs
- 2007-005520-32
- Status last verified
- Oct 2020
- First submitted
- 5 Sep 2008
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT00748410
- Acronym / sponsor ID
- CUC111342
- Conditions
- Colitis, Ulcerative
- Keywords
- CD11b, Ulcerative colitis, 99mTc-HMPAO-labelled leukocyte scintigraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SB-656933 is no longer being developed for ulcerative colitis.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2009 (actual)
- Primary completion
- 12 Dec 2009 (actual)
- Study completion
- 12 Dec 2009 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 14 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in pre-clinical models of colitis. 99m-Tc-HMPAO scintigraphy is a imaging technique which will be used in this study to observe the effect of SB656933 on the migration of PMN to inflamed tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7 Days Repeat Dose | Experimental | Drug: SB-656933 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- A history of ulcerative colitis for at least 3 months
- moderately active UC, either stable on medications or in a flare of the disease
- Mayo endoscopic score of 2 or 3 within 2 days of dosing.
- Male or female between 18 and 65 years of age
- Women of child bearing potential must use an effective method of contraception.
Key exclusion criteria (33 listed)
- The subject has a positive pre-study drug/alcohol screen.
- A positive test for HIV, hepatitis B or C.
- History of regular alcohol consumption within 6 months of the study
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication
- Known allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-656933Also: SB6569337 days repeat dose | Drug | 7 Days Repeat Dose |
Primary outcome
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)
Time frame: Baseline (Day -1) and Day 1 and 7
Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.
5 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to follow-up (7 to 10 days after last dose)
Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Day 1 and 7
Vital Signs Assessment- Heart Rate
Time frame: Day 1 and 7
Changes From Baseline to After Treatment in Faecal Calprotectin Levels
Time frame: Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7
Amount of Medicine in Blood
Time frame: At 1, 2.25, 4, 8 hour on Day 1 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-656933 in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS) (time frame: Baseline (Day -1) and Day 1 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.