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Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03893565
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Ulcerative colitis is a form of inflammatory bowel disease characterized by chronic relapsing and remitting inflammation of the colon and rectum. There remains a high unmet need for novel treatments that achieve a higher rate of efficacy in resolving disease symptoms, and inducing and maintaining mucosal healing to achieve long-term corticosteroid-free remission. T cells are integral to the pathogenesis of ulcerative colitis, and clinical experience with anti-integrin monoclonal antibodies has established the principle of T cell-targeted therapies in the disease. GSK2831781 causes targeted depletion of Lymphocyte activation gene-3 (LAG3+) T cells, and has shown preliminary evidence of clinical efficacy in plaque psoriasis. It is therefore hypothesized that GSK2831781 will selectively deplete activated mucosal T cells in ulcerative colitis, but with relative sparing of resting T cells. This study will investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in subjects with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 20-week Extended Treatment Phase, and a 12-week Follow-Up Phase. Non-Responders allocated to open label treatment who subsequently respond to treatment may spend up to 54 weeks in total on study. Approximately 280 subjects will be included in the study.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Placebo Biological: GSK2831781 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive GSK2831781 Dose Level 1 to 4 or placebo during a double-blind Induction Phase. At Week 10, Responder status will be determined. Responders will receive GSK2831781 Maintenance dosing or placebo in a double-blind Extended Treatment Phase. Non-responders will switch to open label induction consisting of GSK2831781 Induction Dose Level 1 from Week 12 to 22. Open-Label Induction Phase subjects will undergo a further assessment of Responder status at Week 22. Responders from this phase will receive GSK2831781 Maintenance dosing, while Non-Responders will discontinue treatment.
Masking: Double (Participant, Investigator)
Masking Description: This will be a double-blind study. Induction doses will be matched with placebo. For Maintenance dosing, subject and investigator will be masked. Subjects will be allocated to the next treatment phase according to their Responder status. Non-responders to the double-blind Induction Phase will receive treatment in Open-Label Induction phase where there will be no masking.
Primary Purpose: Treatment
Official Title: A Multicentre Randomized, Double-blind (Sponsor Open), Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : April 11, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GSK2831781 dose 1
Eligible subjects will receive GSK2831781 Induction dosing up to Week 10. Subjects identified as Responders who received GSK2831781 during Induction Phase will then receive GSK2831781 Maintenance dosing during the double-blind Extended Treatment Phase, until Week 26.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Experimental: GSK2831781 dose 2
Eligible subjects will receive GSK2831781 Induction dosing up to Week 10. Subjects identified as Responders who received GSK2831781 during Induction Phase will then receive GSK2831781 Maintenance dosing during the double-blind Extended Treatment Phase until Week 26.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Experimental: GSK2831781 dose 3
Eligible subjects will receive GSK2831781 Induction dosing up to Week 10. Subjects identified as Responders who received GSK2831781 during Induction Phase will then receive GSK2831781 Maintenance dosing during the double-blind Extended Treatment Phase until Week 26.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Experimental: GSK2831781 dose 4
Eligible subjects will receive GSK2831781 Induction dosing up to Week 10. Subjects identified as Responders who received GSK2831781 during Induction Phase will then receive GSK2831781 Maintenance dosing during the double-blind Extended Treatment Phase until Week 26.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Placebo Comparator: Placebo matching GSK2831781
Eligible subjects will receive placebo Induction dosing up to Week 10. Subjects identified as Responders who received placebo during Induction Phase will then receive placebo Maintenance dosing during the double-blind Extended Treatment Phase until Week 26.
Drug: Placebo
Commercial saline solution will be administered as placebo during Induction and Maintenance Phase

Open Label GSK2831781 Induction
Subjects identified as non-responders at Week 10 will receive GSK2831781 dose level 1 during Open-label Induction Phase until Week 22.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Open Label GSK2831781 Maintenance
Subjects identified as Responders at Week 22 will then receive GSK2831781 Maintenance dosing during Open-Label Extended Treatment Phase.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.

Open Label Non-Responders to GSK2831781
Subjects identified as non-responders at Week 22 will discontinue study treatment.
Biological: GSK2831781
Subjects will receive different doses of GSK2831781 during Induction and Maintenance Phase.




Primary Outcome Measures :
  1. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 54 ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment.

  2. Number of subjects with abnormal findings for systolic and diastolic blood pressure [ Time Frame: Up to Week 54 ]
    Systolic and diastolic blood pressure of subjects will be measured in a seated or semi-supine position after at least 5 minutes of rest.

  3. Number of subjects with abnormal findings for pulse rate [ Time Frame: Up to Week 54 ]
    Pulse rate of subjects will be measured in a seated or semi-supine position after at least 5 minutes of rest.

  4. Number of subjects with abnormal findings for body temperature [ Time Frame: Up to Week 54 ]
    Body temperature of subjects will be measured in a seated or semi-supine position after at least 5 minutes of rest.

  5. Number of subjects with abnormal findings for hematology parameters [ Time Frame: Up to Week 54 ]
    Blood samples will be collected from subjects for the analysis of hematology parameters as a measure of safety, including platelet count, hemoglobin, hematocrit, neutrophils, lymphocytes, and eosinophils.

  6. Number of subjects with abnormal findings for clinical chemistry parameters [ Time Frame: Up to Week 54 ]
    Blood samples will be collected from subjects for the analysis of clinical chemistry parameters as a measure of safety, including blood urea nitrogen, potassium, aspartate aminotransferase, total bilirubin, creatinine, sodium, alanine aminotransferase (ALT), total protein, glucose, calcium, alkaline phosphatase, albumin and C- reactive protein.

  7. Number of subjects with abnormal findings for urine parameters [ Time Frame: Up to Week 54 ]
    Urine samples will be collected from subjects for the analysis of urine parameters as a measure of safety, including specific gravity and potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite and leukocyte esterase by dipstick test.

  8. Number of subjects with abnormal electrocardiogram findings [ Time Frame: Up to Week 54 ]
    12-lead electrocardiogram will be used to determine abnormal QT interval corrected for heart rate (QTc).

  9. Change from Baseline in Complete 4-domain Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Baseline and Week 10 ]
    Clinical disease assessments will be undertaken using the Complete 4-Domain MCS. It consists of 4 subscales: stool frequency, rectal bleeding, mucosal appearance on endoscopy and/or physician's global assessment of disease activity. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition.


Secondary Outcome Measures :
  1. Percentage of subjects who achieve adapted Mayo endoscopic score of 0 or 1 at Week 10 [ Time Frame: Week 10 ]
    Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis will be determined by adapted Mayo endoscopic score. The scores will range from 0 (Normal or inactive disease) to 3 (Severe disease or spontaneous bleeding, ulceration).

  2. Percentage of subjects who achieve adapted Mayo clinical remission at Week 10 [ Time Frame: Week 10 ]
    Clinical remission is defined as an adapted MCS of <=2, with no individual sub score > 1 and a rectal bleeding score of 0 and stool frequency not greater than Baseline at Week 10.

  3. Percentage of subjects who achieve Mayo clinical response as per adapted MCS at Week 10 [ Time Frame: Week 10 ]
    Clinical response is defined as reduction in adapted MCS >=2 points from Baseline and >=30 percent from Baseline and decrease in the rectal bleeding sub score of >=1 point from Baseline (or a score of 0 or 1).

  4. Change from Baseline in partial Mayo score over time [ Time Frame: Baseline and up to Week 10 ]
    Clinical disease assessments will be undertaken using the partial Mayo Score. It consists of 3 subscales: stool frequency, rectal bleeding, and/or physician's global assessment of disease activity. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition.

  5. Change from Baseline in Mayo endoscopic score at Week 10 [ Time Frame: Baseline and Week 10 ]
    Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis will be determined by Mayo endoscopic score on a scale ranging from 0 (Normal or inactive disease) to 3 (Severe disease or spontaneous bleeding, ulceration).

  6. Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10 [ Time Frame: Baseline and Week 10 ]
    UCEIS will be used as an additional tool to assess disease activity based on endoscopic vascular pattern, bleeding, erosions and ulcerations. Each item has 3 or 4 levels of severity and is given a score. The scores for each individual item are combined into a total score ranging from 0 to 8. A higher score indicates increased endoscopic severity of Ulcerative Colitis.

  7. Change from Baseline in histological severity as determined by the Robarts Histopathology Index at Week 10 [ Time Frame: Baseline and Week 10 ]
    The Robarts Histopathology Index will be assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate; neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Robarts Histopathology Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity).

  8. Change from Baseline in histological severity as determined by the Nancy Histological Index at Week 10 [ Time Frame: Baseline and Week 10 ]
    The Nancy Histopathology Index will be assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate; neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Nancy Histopathology Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity).

  9. Change from Baseline in histological severity as determined by Geboes Score at Week 10 [ Time Frame: Baseline and Week 10 ]
    Biopsy samples will be assessed in Geboes score raning from 0 to 5. Lower values represent a better outcome.

  10. Change from Baseline in serum C reactive protein over time [ Time Frame: Baseline and up to Week 10 ]
    A blood sample will be collected for analysis of C reactive protein to characterize the impact of GSK2831781.

  11. Change from Baseline in fecal calprotectin over time [ Time Frame: Baseline and up to Week 10 ]
    Fecal samples will be collected for analysis of calprotectin to characterize the impact of GSK2831781 on this biomarker of intestinal inflammation.

  12. Plasma pharmacokinetic concentration of GSK2831781 [ Time Frame: At any time on Days 1, 15, 43, 71, 85, 99, 100, 101, 102, 104, 106, 109, 127, 155, 183, 197, 211, 295 and 379 ]
    Blood samples will be collected for pharmacokinetic analysis of GSK2831781.

  13. Area under the concentration-time curve over the dosing interval AUC (0-tau) of GSK2831781 [ Time Frame: At any time on Days 1, 15, 43, 71, 85, 99, 100, 101, 102, 104, 106, 109, 127, 155, 183, 197, 211, 295 and 379 ]
    Blood samples will be collected for pharmacokinetic analysis of GSK2831781.

  14. Maximum observed plasma concentration (Cmax) of GSK2831781 [ Time Frame: At any time on Days 1, 15, 43, 71, 85, 99, 100, 101, 102, 104, 106, 109, 127, 155, 183, 197, 211, 295 and 379 ]
    Blood samples will be collected for pharmacokinetic analysis of GSK2831781.

  15. Time to reach Cmax (Tmax) of GSK2831781 [ Time Frame: At any time on Days 1, 15, 43, 71, 85, 99, 100, 101, 102, 104, 106, 109, 127, 155, 183, 197, 211, 295 and 379 ]
    Blood samples will be collected for pharmacokinetic analysis of GSK2831781.

  16. Soluble LAG3 (sLAG3) concentrations of GSK2831781 [ Time Frame: At any time on Days 1, 15, 43, 71, 85, 99, 100, 101, 102, 104, 106, 109, 127, 155, 183, 197, 211, 295 and 379 ]
    Blood samples will be collected for analysis of sLAG3

  17. Number of subjects with anti-drug antibodies over time [ Time Frame: Up to Week 54 ]
    Serum samples will be assessed for the presence of anti-drug antibodies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 18 years of age or older and > 40 kilograms (kg) at the time of signing the informed consent.
  • Subjects who have a diagnosis of ulcerative colitis, established at least 3 months prior to screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and biopsy.
  • Complete Mayo Score of 6 to 12, with disease extending >= 15 centimeters (cm) from the anal verge, with a centrally read endoscopic sub score of >=2 at screening endoscopy, and a rectal bleeding sub score >=1.
  • A history of at least one of the following: inadequate response to, loss of response to, or intolerance to azathioprine or mercaptopurine (including thiopurine methyltransferase [TPMT] genetic mutation precluding use), ciclosporin, tacrolimus or methotrexate; inadequate response to, intolerance to, or demonstrated dependence on oral corticosteroids; inadequate response to, loss of response to, or intolerance to one biologic class only for the treatment of ulcerative colitis: either one or more anti- tumor necrosis factor (TNF) therapies (example given [e.g.] infliximab, adalimumab, golimumab, or biosimilar) or vedolizumab.
  • Surveillance colonoscopy (performed according to local standards) within 12 months of screening (or during screening, if required) for subjects with Pancolitis of >8 years duration; or subjects with left-sided colitis of >12 years duration; or subjects with primary sclerosing cholangitis. For subjects for whom this criterion does not apply, colorectal cancer surveillance should be undertaken according to local or national guidelines for subjects with age >=50, or with other known risk factors for colorectal cancer.
  • A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP); A WOCBP who agrees to use a highly effective contraceptive method for at least 4 weeks prior to dosing, until the Follow-Up visit.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Subjects with a current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischemic colitis.
  • Subjects with fulminant ulcerative colitis (as defined by 6 bloody stools daily and 1 or more of body temperature >=100.4 degrees Fahrenheit (or 38 degree Celsius) or heart rate >90 beats per minute), or toxic megacolon.
  • Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for ulcerative colitis.
  • Subjects with any uncontrolled medical conditions, other than active ulcerative colitis, that in the opinion of the investigator put the subject at unacceptable risk or interfere with study assessments or integrity of the data. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study.
  • Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the investigator they would interfere with the ability of a subject to complete the study.
  • An active infection or a history of serious infections as follows: a) Use of antimicrobials (antibacterials, antivirals, antifungals or antiparasitic agents) for an infection within 30 days before first dose (topical treatments may be allowed at the Medical Monitor's discretion). b) A history of opportunistic infections within 1 year of screening (e.g. Pneumocystis jirovecii, aspergillosis or Cytomegalovirus colitis). This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature. c) Recurrent or chronic infection or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject. d) Symptomatic herpes zoster within 3 months prior to screening. e) History of tuberculosis (active or latent), irrespective of treatment status. f) A positive diagnostic tuberculosis test at screening (defined as a positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the subject may have the test repeated once and if their second test is negative they will be eligible. In the event a second test is also indeterminate, the investigator has the option to undertake Purified Protein Derivative (PPD) testing. If the PPD reaction is < 5 millimeter (mm), then the subject is eligible. If the reaction is >= 5mm, or PPD testing is not undertaken, the subject is not eligible. g) Positive Clostridium difficile toxin test during screening. However, rescreening can be undertaken following successful treatment.
  • Current or history of chronic liver or biliary disease (with the exception of Gilbert's syndrome, asymptomatic gallstones or uncomplicated fatty liver disease).
  • Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency (unless the subject has a documented history of selective immunoglobulin A deficiency).
  • A major organ transplant (e.g. heart, lung, kidney, liver, pancreas) or hematopoietic stem cell/marrow transplant.
  • Any planned major surgical procedure during the study.
  • A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma in situ of the uterine cervix (within 3 years) that has been fully treated and shows no evidence of recurrence.
  • A change in dose of oral sulfasalazine or aminosalicylate within 2 weeks prior to Baseline endoscopy.
  • Greater than 20 mg per day oral prednisolone (or equivalent), or a change in dose of corticosteroid within 2 weeks prior to baseline endoscopy, or be unable to maintain a stable dose of corticosteroids (<=20 mg oral prednisolone or equivalent) until Week 12.
  • Topical (rectal) corticosteroids or topical (rectal) aminosalicylate within 2 weeks prior to Baseline endoscopy.
  • Initiation or a change in dose of mercaptopurine or azathioprine (including initiation or discontinuation of allopurinol) or methotrexate within 8 weeks prior to Baseline endoscopy.
  • Treatment with ciclosporin, tacrolimus or thalidomide within 4 weeks prior to Baseline endoscopy.
  • Treatment with an anti-TNF biologic within 8 weeks prior to Baseline endoscopy, or vedolizumab within 12 weeks prior to Baseline endoscopy.
  • A history of treatment with vedolizumab and an anti-TNF biologic, regardless of treatment response (unless exposure to one or both drugs was only within a clinical trial setting).
  • A history of treatment with a monoclonal antibody therapy or targeted small molecule therapy for the treatment of ulcerative colitis not listed above.
  • Received live vaccination within 4 weeks of Day 1 or plan to receive during the study until Follow-Up.
  • 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: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigation product (whichever is longer).
  • Absolute neutrophil count <1.5 times 10^9 cells per liter (L) or a hemoglobin <80 grams per liter (g/L) or lymphocyte count <0.8 times 10^9 cells /L.
  • Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation <60 milliliter (mL) per minute per 1.73 m^2 at screening.
  • ALT >2 times upper limit of normal (ULN) and bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent) at screening.
  • Other clinically significant abnormalities of laboratory assessments, as judged by the investigator and/or GlaxoSmithKline Medical Monitor that could affect the safety of the subject, or the interpretation of the data from the study.
  • Presence of hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), or positive hepatitis C antibody result at screening (NB. subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C ribonucleic acid [RNA] test is obtained).
  • Positive serology for human immunodeficiency virus (HIV) at screening.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
  • QT interval corrected for heart rate (QTc) >450 milliseconds (msec) or QTc >480 msec for subjects with bundle branch block at screening and Day 1. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or over read.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893565


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
Rialto, California, United States, 92337
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Zeid Kayali         
Bulgaria
GSK Investigational Site Recruiting
Sofia, Bulgaria, 1612
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ludmila Tankova         
Estonia
GSK Investigational Site Recruiting
Tallinn, Estonia, 10117
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jaak Talli         
GSK Investigational Site Recruiting
Tallinn, Estonia, 10617
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Vadim Brjalin         
France
GSK Investigational Site Recruiting
Monpellier, France, 34090
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Romain Altwegg         
GSK Investigational Site Recruiting
Saint-Priest en Jarez, France, 42270
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Xavier Roblin         
GSK Investigational Site Recruiting
Toulouse, France, 31059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Cyrielle Gilletta         
Poland
GSK Investigational Site Recruiting
Rzeszow, Poland, 35-326
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lucja Puszko         
South Africa
GSK Investigational Site Recruiting
Cape Town, South Africa, 7708
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John P Wright         
United Kingdom
GSK Investigational Site Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Arthur Kaser         
GSK Investigational Site Recruiting
Prescot, Merseyside, United Kingdom, L35 5DR
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rajiv Chandy         
GSK Investigational Site Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Simon Travis         
GSK Investigational Site Recruiting
London, United Kingdom, E11 1NR
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sami Hoque         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03893565     History of Changes
Other Study ID Numbers: 204869
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
GSK2831781, ulcerative colitis, anti-LAG3 cell
depleting monoclonal antibody, dose-response
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs