Colitis, UlcerativePhase 1NCT02000453

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

A Phase 1 study testing GSK2586184 400mg in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Colitis, Ulcerative
What is being tested?: GSK2586184 400mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteNetherlands
Study dates: 20 Dec 2013to 8 Aug 2014
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, between 18 and 75 years of age inclusive, at the time of signing the informed consent.
Moderate to severely active UC at least 6 months prior to Screening confirmed by colonoscopy or sigmoidoscopy with video recording, and biopsy.
A Mayo score of 6 to 12 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least 1 of the following (oral corticosteroids or any oral 5-aminosalicylic acid (ASA) or both as defined below): Oral 5-ASA at a stable dose (>=2.4grams (g)/day) for at least 4 weeks from first dose. Must remain on a stable dose until end of treatment, Stable oral corticosteroid dose (prednisone of <=20 mg/day or equivalent) for at least 14 days prior to Baseline (must remain on a stable dose until end of treatment).
Otherwise healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
A female subject is eligible to participate if she is of: Non-childbearing potential defined as: pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units (MlU)/milliliter (mL) and estradiol <40 picograms (pg)/mL (<147 picomole [pmol]/liter [L]) is confirmatory). Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status before study enrollment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Male subjects with female partners of child-bearing potential must agree to use acceptable contraception methods. This criterion must be followed during the study and for at least 2 weeks after their last dose.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

Subjects with fulminant UC, or UC limited to rectum.
Subjects with previous colonic surgery, histological evidence of colonic dysplasia, or bowel stricture.
Subjects who have received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.
Unable to refrain from the use of the prohibited drugs before the stated time before first dose of study medication until completion of the follow-up visit.
A live vaccination within 4 weeks before the first dose of study medication, or a live vaccination planned during the course of the study (until completion of the follow-up visit).
A major organ transplant (e.g. heart, lung, kidney, liver) or haematopoietic stem cell/marrow transplant.

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Significant unstable or uncontrolled acute or chronic disease unrelated to UC (i.e. cardiovascular including uncontrolled hypertension, hypercholesterolemia, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
A planned surgical procedure that, in the opinion of the investigator, makes the subject unsuitable for the study.
A history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
Acute or chronic infections, as follows: Known previous, active or latent infection with Mycobacterium Tuberculosis, Currently on any suppressive therapy for a chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria), Hospitalisation for treatment of infection within 60 days before first dose, Use of parenteral (IV or intramuscular) antibiotics (antibacterials, antivirals, antifungals, or antiparasitic agents) within 60 days before first dose, Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc antibody as follows: subjects positive for HBsAg are excluded; and subjects positive for anti-HBc antibody (regardless of anti-HBs antibody status) are excluded, Positive test for Hepatitis C antibody confirmed on the same sample with a Hepatitis C third generation immunoassay or PCR. Subjects who are positive for Hepatitis C antibody, but negative when the Hepatitis C third generation immunoassay or PCR is performed on the same sample, will be eligible to participate, Subjects who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C third generation immunoassay or PCR is performed on the same sample, will not be eligible to participate.
A positive test for HIV antibody.
Haemoglobin <11 g/decilitre (dL) (6.83 millimoles[mmol]/L), haematocrit <30%, white blood cells (WBC) count (absolute) <3×10^9/L, neutrophils <1.5×10^9/L, platelets <100×10^9/L, lymphocytes<1×10^9/L.
Current or history of renal disease, or estimated creatinine clearance <60 mL/min/1.73m^2 or serum creatinine >1.5 upper limit of normal (ULN).
Single QT duration corrected (QTc) >450 millisecond (msec); or QTc >480 msec in subjects with Bundle Branch Block.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Alanine aminotransferase (ALT) >2xULN; alkaline phosphatase and bilirubin ≥ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >168g for males or >112 g for females (8 g of alcohol is equivalent to 240mL of beer, 125mL of wine or 25mL spirits).
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). Or if the subject plans to take part in another clinical trial at the same time as participating in this clinical trial.
History of sensitivity to any components of the study medications, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation.
Where donation of blood or blood products, in addition to those required for the study, would be in excess of 500 mL within a 56 day period.
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Unable to refrain from the consumption of grapefruit or grapefruit juice from 3 weeks before the first dose of study medication until 2 weeks after the last dose of study medication.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

GSK Investigational Site
Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.

Conditions: Colitis, Ulcerative
Being tested: GSK2586184 400mg
Keywords: Quality of Life, Infection, GSK2586184, ulcerative colitis
Medical subject headings: Colitis, Ulcerative, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2586184 400mgDrug
White film coated round biconvex GSK2586184 200 mg tablets, administered 2 X twice daily. Tablet containing GSK2586184A, with the following excipients: microcrystalline cellulose, lactose, hypromellose, croscarmellose sodium, magnesium stearate and titanium dioxide.

Study groups in NCT02000453
Study group	Role	What they receive
GSK2586184	Experimental	A total of 15 subjects to be administered 400 mg GSK2586184 Tablet (200 mg X 2) twice daily for up to 56 days Receives: Drug: GSK2586184 400mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of twice daily doses of GSK2586184
Safety and tolerability, as determined by laboratory tests (including haematology, clinical chemistry and serum creatinine) vital signs, 12-lead Electrocardiogram (ECG), physical examination, and adverse event reporting.
Measured: Up to Week 8
Safety as assessed by the collection of adverse events (AEs)
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Measured: Up to Week 8
Safety as assessed by laboratory parameters
Laboratory parameters include hematology, clinical chemistry, urinalysis Absolute values and changes over time of hematology, clinical chemistry, urinalysis will be assessed.
Measured: Up to Week 8
Safety as assessed by vital sign measurement
Vital signs include systolic blood pressure, diastolic blood pressure, temperature, and heart rate.
Measured: Up to Week 8
Safety as assessed by ECG rhythm.
Continuous monitoring of a subject' heart rate and rhythm by ECG.
Measured: Up to Week 8

Secondary outcomes (8)

Efficacy of GSK2586184 in achieving clinical and endoscopic remission after 8 weeks of treatment
Efficacy assessed by total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point, and reduction in endoscopic mucosal appearance score of >= 1.
Measured: Up to Week 8
Efficacy of GSK2586184 in achieving symptomatic clinical remission after 8 weeks
Efficacy assessed by Mayo score for the proportion of subjects who achieve a score of 0 for both rectal bleeding and stool frequency.
Measured: Up to Week 8
Efficacy of GSK2586184 in achieving clinical response
Efficacy assessed by Mayo score for the proportion of subjects of subjects who achieve a decrease from baseline in total Mayo score of >=3 points, with an accompanying decrease in the sub score for rectal bleeding of at least 1 point or an absolute sub score for rectal bleeding
Measured: Up to Week 8
Efficacy of GSK2586184 in achieving mucosal healing.
Efficacy assessed by proportion of subjects who achieve an absolute sub score for endoscopy of 0 or 1, at week 8. And change from baseline of mucosal appearance determined by ulcerative colitis endoscopic index of severity (UCEIS).
Measured: Up to Week 8
The effect of twice daily doses of GSK2586184 on health related quality of life (QoL) in UC patients.
Change from baseline of inflammatory bowel disease questionnaire (IBDQ) was assessed
Measured: Up to Week 8
The effect of twice daily doses of GSK2586184 on serum C reactive protein (CRP) levels in UC patients
Change from baseline in mean serum CRP levels was assessed.
Measured: Up to Week 8
The effect of twice daily doses of GSK2586184 on faecal calprotectin levels
Change from baseline of mean faecal calprotectin levels was assessed.
Measured: Up to Week 8
The plasma pharmacokinetics of repeated, twice daily doses of GSK2586184
Plasma concentrations and derived pharmacokinetic parameters of GSK2586184 were assessed.
Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20138 Aug 2014

First posted4 Dec 2013 (estimated)
Study start20 Dec 2013
Primary completion8 Aug 2014
Study completion8 Aug 2014

Why it stopped: GSK has elected to terminate development principally as a result of the statin drug-drug interaction (DDI) study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02000453
Sponsor's protocol ID: 200208
Other IDs: 2013-001369-18
Status last verified: Oct 2020
First submitted: 27 Nov 2013
Last updated: 9 Oct 2020
Results posted: No
Data monitoring committee: No

Publications

De Vries LCS, Ludbrook VJ, Hicks KJ, D'Haens GR. GSK2586184, a JAK1 selective inhibitor, in two patients with ulcerative colitis. BMJ Case Rep. 2017 Aug 7;2017:bcr2017221078. doi: 10.1136/bcr-2017-221078.
PubMed 28790099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colitis, Ulcerative trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.
ClinicalTrials.gov ID: NCT02000453
Acronym / sponsor ID: 200208
Conditions: Colitis, Ulcerative
Keywords: Quality of Life, Infection, GSK2586184, ulcerative colitis
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: GSK has elected to terminate development principally as a result of the statin drug-drug interaction (DDI) study.
Enrolment: 2 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Prof Geert D'Haens, AMC, Amsterdam
Study start: 20 Dec 2013 (actual)
Primary completion: 8 Aug 2014 (actual)
Study completion: 8 Aug 2014 (actual)
First posted: 4 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GSK2586184	Experimental	Drug: GSK2586184 400mgA total of 15 subjects to be administered 400 mg GSK2586184 Tablet (200 mg X 2) twice daily for up to 56 days

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female, between 18 and 75 years of age inclusive, at the time of signing the informed consent.
Moderate to severely active UC at least 6 months prior to Screening confirmed by colonoscopy or sigmoidoscopy with video recording, and biopsy.
A Mayo score of 6 to 12 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least 1 of the following (oral corticosteroids or any oral 5-aminosalicylic acid (ASA) or both as defined below): Oral 5-ASA at a stable dose (>=2.4grams (g)/day) for at least 4 weeks from first dose. Must remain on a stable dose until end of treatment, Stable oral corticosteroid dose (prednisone of <=20 mg/day or equivalent) for at least 14 days prior to Baseline (must remain on a stable dose until end of treatment).
Otherwise healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
A female subject is eligible to participate if she is of: Non-childbearing potential defined as: pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.

Key exclusion criteria (22 listed)

Subjects with fulminant UC, or UC limited to rectum.
Subjects with previous colonic surgery, histological evidence of colonic dysplasia, or bowel stricture.
Subjects who have received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.
Unable to refrain from the use of the prohibited drugs before the stated time before first dose of study medication until completion of the follow-up visit.
A live vaccination within 4 weeks before the first dose of study medication, or a live vaccination planned during the course of the study (until completion of the follow-up visit).

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
GSK2586184 400mgWhite film coated round biconvex GSK2586184 200 mg tablets, administered 2 X twice daily. Tablet containing GSK2586184A, with the following excipients: microcrystalline cellulose, lactose, hypromellose, croscarmellose sodium, magnesium stearate and titanium dioxide.	Drug	GSK2586184

Primary outcome

Safety and Tolerability of twice daily doses of GSK2586184
Time frame: Up to Week 8
Safety and tolerability, as determined by laboratory tests (including haematology, clinical chemistry and serum creatinine) vital signs, 12-lead Electrocardiogram (ECG), physical examination, and adverse event reporting.
Safety as assessed by the collection of adverse events (AEs)
Time frame: Up to Week 8
AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
Safety as assessed by laboratory parameters
Time frame: Up to Week 8
Laboratory parameters include hematology, clinical chemistry, urinalysis Absolute values and changes over time of hematology, clinical chemistry, urinalysis will be assessed.
Safety as assessed by vital sign measurement
Time frame: Up to Week 8
Vital signs include systolic blood pressure, diastolic blood pressure, temperature, and heart rate.
Safety as assessed by ECG rhythm.
Time frame: Up to Week 8
Continuous monitoring of a subject' heart rate and rhythm by ECG.

8 secondary outcomes

Efficacy of GSK2586184 in achieving clinical and endoscopic remission after 8 weeks of treatment
Time frame: Up to Week 8
Efficacy of GSK2586184 in achieving symptomatic clinical remission after 8 weeks
Time frame: Up to Week 8
Efficacy of GSK2586184 in achieving clinical response
Time frame: Up to Week 8
Efficacy of GSK2586184 in achieving mucosal healing.
Time frame: Up to Week 8
The effect of twice daily doses of GSK2586184 on health related quality of life (QoL) in UC patients.
Time frame: Up to Week 8
The effect of twice daily doses of GSK2586184 on serum C reactive protein (CRP) levels in UC patients
Time frame: Up to Week 8
The effect of twice daily doses of GSK2586184 on faecal calprotectin levels
Time frame: Up to Week 8
The plasma pharmacokinetics of repeated, twice daily doses of GSK2586184
Time frame: Up to Week 8

Results and safety

The study was stopped early (reason given: GSK has elected to terminate development principally as a result of the statin drug-drug interaction (DDI) study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Background: PubMed 28790099De Vries LCS, Ludbrook VJ, Hicks KJ, D'Haens GR. GSK2586184, a JAK1 selective inhibitor, in two patients with ulcerative colitis. BMJ Case Rep. 2017 Aug 7;2017:bcr2017221078. doi: 10.1136/bcr-2017-221078.

Related trials for Colitis, Ulcerative

Active, not recruitingPhase 3
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Enrolling by invitationPhase 4
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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 1 study testing GSK2586184 400mg 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 8 inclusion and 22 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 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Safety and Tolerability of twice daily doses of GSK2586184 (time frame: Up to Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000453, which also lists 1 linked publication.

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 9 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.