AzTrials
AzTrials

Crohn's DiseasePhase 3SHIELD-4NCT01536418

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

A Phase 3 study testing GSK1605786A in people with Crohn's Disease, run by GlaxoSmithKline at 227 sites in 31 countries.

Terminated

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

Official record
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Trial summary

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
GSK1605786A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
227 sitesin 31 countries
Study dates
11 Nov 2011to 17 Oct 2013
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 years or older
  • Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications
  • Diagnosis of Crohn's disease for more than 4 months with small bowel and/or colonic involvement
  • Current evidence of moderately-to-severely active disease defined by a baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive
  • Confirmation of active disease by elevated CRP (greater than or equal to the upper limit of normal for the highly sensitive C-reactive protein test) or elevated levels of faecal calprotectin
  • History of inadequate response and/or intolerance or adverse event leading to discontinuation of at least one of the following treatments for Crohn's disease: corticosteroids or immunosuppressants
Show all 9Show fewer
  • Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
  • Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
  • Female subjects of child-bearing potential are eligible if not pregnant or nursing and committed to use of contraceptive methods with a failure rate of less than 1 percent per year

Who cannot join

  • Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti-tissue transglutaminase antibodies)
  • Diagnosis of ulcerative or indeterminate colitis
  • Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
  • Bowel surgery, other than appendectomy, within 12 weeks prior to screening and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period
  • Extensive colonic resection, subtotal or total colectomy
  • Presence of ileostomies, colostomies or rectal pouches
Show all 39Show fewer
  • Fixed symptomatic stenoses of small bowel or colon
  • History of more than 3 small bowel resections or diagnosis of short bowel syndrome
  • Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medicaitons
  • Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study. Prohibited medications include the following:
  • Biologic use: Use of any TNF inhibitor (such as infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to Randomisation
  • Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to Screening
  • Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to Screening
  • Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to Screening
  • Enteral feeding: Use of tube or enteral feeding, elemental diet within 2 weeks prior to Screening
  • Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks prior to Screening
  • Leukocytapheresis or granulocytapheresis within 2 weeks prior to Screening
  • Paracetamol or acetaminophen greater than 2 grams per day
  • Opioid analgesics for worsening Crohn's disease pain are prohibited when used on a regular daily basis for more than 3 days
  • Digoxin or related cardiac glycosides: Use within 7 days prior to Screening
  • Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
  • Positive immunoassay for Clostridium difficile
  • Known HIV infection
  • Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
  • Immunization with a live vaccine within 4 weeks of Screening and throughout the study with the exception of the influenza vaccine
  • Positive hepatitis B surface antigen or hepatitis B core antibody test or positive Hepatitis C test result at Screening
  • Active or latent tuberculosis infection determined by results of QuantiFERON TB Gold test
  • Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
  • Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise
  • Evidence of hepatic dysfunction, viral hepatitis, or abnormalities in liver function test results
  • Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
  • Congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection
  • Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
  • History of evidence of adenomatous colonic polyps that have not been removed.
  • History of evidence of colonic mucosal dysplasia
  • If female, is pregnant, has a positive pregnancy test or is breast-feeding
  • Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (such as an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)
  • Medical history of sensitivity to any of the components of GSK1605786A (microcrystalline cellulose, crospovidone, sodium stearyl fumarate).
  • Use of any investigational product within 30 days prior to screening

Trial locations and contacts

227 sites in 31 countries.

227 sites in 31 countries

United States40 sites

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Brooklyn, New York, 11206

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Chesterfield, Michigan, 48047

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Christiansburg, Virginia, 24073

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Danville, Virginia, 24541

  • GSK Investigational Site

    Denver, Colorado, 80222

  • GSK Investigational Site

    Hamden, Connecticut, 06518

  • GSK Investigational Site

    Jacksonville, Florida, 32256-6004

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lake Success, New York, 11042

  • GSK Investigational Site

    Lee's Summit, Missouri, 64064

  • GSK Investigational Site

    Little Rock, Arizona, 72205

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Mexico, Missouri, 65265-3726

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Nashville, Tennessee, 37232

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Ogden, Utah, 84405

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Suwanee, Georgia, 30024

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Towson, Maryland, 21286

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Germany16 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Brinkum/Stuhr, Lower Saxony, 28816

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, 20148

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Jena, Thuringia, 07747

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39120

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Minden, North Rhine-Westphalia, 32423

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Weiden, Bavaria, 92637

Other trials in Germany

Japan16 sites

  • GSK Investigational Site

    Aichi, 441-8570

  • GSK Investigational Site

    Aichi, 460-0012

  • GSK Investigational Site

    Aichi, 470-1219

  • GSK Investigational Site

    Fukuoka, 802-0077

  • GSK Investigational Site

    Fukuoka, 818-8502

  • GSK Investigational Site

    Fukuoka, 830-0011

  • GSK Investigational Site

    Hiroshima, 720-8520

  • GSK Investigational Site

    Hokkaido, 065-0033

  • GSK Investigational Site

    Hyōgo, 663-8501

  • GSK Investigational Site

    Kagoshima, 892-0846

  • GSK Investigational Site

    Kanagawa, 220-0045

  • GSK Investigational Site

    Kanagawa, 247-0056

  • GSK Investigational Site

    Osaka, 530-0011

  • GSK Investigational Site

    Shizuoka, 430-0846

  • GSK Investigational Site

    Tokyo, 169-0073

  • GSK Investigational Site

    Wakayama, 641-8510

Other trials in Japan

Israel11 sites

  • GSK Investigational Site

    Afula, 18101

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Tel Aviv, 64239

  • GSK Investigational Site

    Tsrifin, 70300

Other trials in Israel

Spain11 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Elche, 03293

  • GSK Investigational Site

    Fuenlabrada (Madrid), 28942

  • GSK Investigational Site

    Galdakao/Vizcaya, 48960

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Sabadell (Barcelona), 08208

  • GSK Investigational Site

    Santander, 39008

Other trials in Spain

Russia10 sites

  • GSK Investigational Site

    Irkutsk, 664079

  • GSK Investigational Site

    Kazan', 420064

  • GSK Investigational Site

    Lipetsk, 398055

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Rostov-on-Don, 344091

  • GSK Investigational Site

    Saint Petersburg, 196247

  • GSK Investigational Site

    Saint Petersburg, 197110

  • GSK Investigational Site

    Samara, 443011

  • GSK Investigational Site

    Tomsk, 634063

Other trials in Russia

Hungary9 sites

  • GSK Investigational Site

    Békéscsaba, 5600

  • GSK Investigational Site

    Budapest, 1062

  • GSK Investigational Site

    Budapest, 1083

  • GSK Investigational Site

    Budapest, 1088

  • GSK Investigational Site

    Budapest, 1136

  • GSK Investigational Site

    Debrecen, 4025

  • GSK Investigational Site

    Mosonmagyaróvár, 9200

  • GSK Investigational Site

    Szekszárd, 7100

  • GSK Investigational Site

    Vác, 2600

Other trials in Hungary

Ukraine9 sites

  • GSK Investigational Site

    Chernivtsi, 58005

  • GSK Investigational Site

    Dnipropetrovsk, 49044

  • GSK Investigational Site

    Donetsk, 83017

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kyiv

  • GSK Investigational Site

    Odesa, 65117

  • GSK Investigational Site

    Simferopol, 95017

  • GSK Investigational Site

    Vinnytsia, 21029

Other trials in Ukraine

United Kingdom9 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    Glasgow, Lanarkshire, G4 0SF

  • GSK Investigational Site

    Harrow, Middlesex, HA1 3UJ

  • GSK Investigational Site

    London, E1 2AT

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Newcastle upon Tyne, NE1 4LP

  • GSK Investigational Site

    Oxford, OX3 9DU

Other trials in United Kingdom

Austria7 sites

  • GSK Investigational Site

    Hall in Tirol, 6060

  • GSK Investigational Site

    Linz, A-4021

  • GSK Investigational Site

    Oberpullendorf, 7350

  • GSK Investigational Site

    St.Veit/Glan, 9300

  • GSK Investigational Site

    Vienna, 1030

  • GSK Investigational Site

    Vienna, 1050

  • GSK Investigational Site

    Vienna, 1090

Other trials in Austria

New Zealand7 sites

  • GSK Investigational Site

    Canterbury, 8011

  • GSK Investigational Site

    Dunedin, 9054

  • GSK Investigational Site

    Hamilton, 3204

  • GSK Investigational Site

    Lower Hutt, 6007

  • GSK Investigational Site

    Otahuhu, 1640

  • GSK Investigational Site

    Takapuna, Auckland, 1309

  • GSK Investigational Site

    Tauranga, 3143

Other trials in New Zealand

Slovakia7 sites

  • GSK Investigational Site

    Bratislava, 831 04

  • GSK Investigational Site

    Bratislava, 851 01

  • GSK Investigational Site

    Bratislava, 851 07

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Nové Mesto nad Váhom, 915 01

  • GSK Investigational Site

    Prešov, 080 01

  • GSK Investigational Site

    Trnava, 917 02

Other trials in Slovakia

South Korea7 sites

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Pusan, 602-739

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130702

  • GSK Investigational Site

    Seoul, 135-230

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Wŏnju, 220701

Other trials in South Korea

Australia6 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Bankstown, New South Wales, 2200

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Prahran, Victoria, 3181

Other trials in Australia

Belgium6 sites

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Czechia6 sites

  • GSK Investigational Site

    Hradec Králové, 500 12

  • GSK Investigational Site

    Olomouc, 77520

  • GSK Investigational Site

    Prague, 140 59

  • GSK Investigational Site

    Prague, 190 61

  • GSK Investigational Site

    Teplice, 415 29

  • GSK Investigational Site

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Netherlands6 sites

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Rotterdam, 3083 AN

Other trials in Netherlands

Bulgaria5 sites

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Greece5 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 11522

  • GSK Investigational Site

    Athens, 18454

  • GSK Investigational Site

    Heraklion, Crete, 71110

  • GSK Investigational Site

    Ioannina, 45110

Other trials in Greece

Poland5 sites

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Bydgoszcz, 85-681

  • GSK Investigational Site

    Lublin, 20-607

  • GSK Investigational Site

    Sopot, 81-756

  • GSK Investigational Site

    Wroclaw, 53-333

Other trials in Poland

Denmark4 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Aarhus, 8000

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Koebenhavn NV, 2400

Other trials in Denmark

France4 sites

  • GSK Investigational Site

    Clichy, 92118

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42270

Other trials in France

Portugal4 sites

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Lisbon, 1769-001

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Viseu, 3504-509

Other trials in Portugal

Taiwan4 sites

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Canada3 sites

  • GSK Investigational Site

    Kingston, Ontario, K7L 5G2

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    London, Ontario, N6A 5W9

Other trials in Canada

Estonia3 sites

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tallinn, EE-10138

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin, New Territories

Other trials in Hong Kong

Switzerland2 sites

  • GSK Investigational Site

    Bern, 3004

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Chile1 site

  • GSK Investigational Site

    Viña del Mar, 2520012

Other trials in Chile

Italy1 site

  • GSK Investigational Site

    Genova, 16132

Other trials in Italy

Turkey (Türkiye)1 site

  • GSK Investigational Site

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

Read the detailed description

This is a multi-centre, double-blind, randomised, active treatment, parallel group study designed to induce clinical response and/or clinical remission with two oral doses of GSK1605786A (500 milligrams once daily, 500 milligrams twice daily) over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. The primary objective of this study is to qualify subjects for enrolment into a follow up 52 week maintenance study CCX114157. Subjects who achieve induction of clinical response (CDAI decrease from baseline of at least 100 points) or remission (CDAI score less than 150) at Week 12 following treatment with GSK1605786A will be eligible for enrolment into the maintenance study CCX114157. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission.

The study is planned to randomise approximately 900 subjects (450 subjects per group) with active Crohn's disease who have been diagnosed for at least 4 months, with documented history of disease in the small and/or large intestine, and characterised by a CDAI score between 220 to 450 (inclusive). Subjects will be required to have evidence of current active inflammation by elevated C-reactive protein (greater than the upper limit of normal of the highly sensitive C-reactive protein test) OR an elevated level of faecal calprotectin. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Inclusion of subjects who received prior treatment with an anti-tumor necrosis factor agent and discontinued due to loss or lack of efficacy will be limited to approximately 50 percent of the study population. Following a 3-week screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 milligrams once daily or twice daily) for 12 weeks. All subjects meeting the definition of responder (CDAI decrease from baseline of at least 100 points) or who are in remission (CDAI score less than 150 points) at Week 12 will be eligible for randomisation into an ongoing maintenance study (CCX114157). Subjects who do not meet the definition of responder or who are not in remission at Week 12 will not be eligible to participate in study CCX114157.

For subjects who complete the study the minimum duration of participation is 15 weeks and the maximum duration is 19 weeks.

Conditions
Crohn's Disease
Being tested
GSK1605786A
Keywords
Crohn's disease, chemokine receptor 9 antagonist, Crohn's Disease Activity Index, active treatment
Medical subject headings
Crohn Disease

What participants receive

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

  • GSK1605786ADrug

    500 milligrams once daily, orally administered for 12 weeks

  • GSK1605786ADrug

    500 milligrams twice daily, orally adminstered for 12 weeks

Study groups in NCT01536418
Study groupRoleWhat they receive
GSK1605786A, 500 milligrams, once dailyExperimental500 milligrams once daily, orally administered for 12 weeks
Receives: Drug: GSK1605786A
GSK1605786A, 500 milligrams twice dailyExperimental500 milligrams twice daily, orally administered for 12 weeks
Receives: Drug: GSK1605786A

What is being measured

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

  1. Percentage of Participants Achieving Clinical Response at Week 12

    Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.

    Measured: At Week 12

Secondary outcomes (6)

  1. Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12

    Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission.

    Measured: Week 8 and Week 12

  2. Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12

    Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.

    Measured: Both Week 8 and Week 12

  3. Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12

    Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.

    Measured: Baseline (Screening) and Weeks 4, 8, and Week 12

  4. Change From Baseline in Faecal Calprotectin at Week 12

    Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.

    Measured: Baseline (Screening) and Week 12

  5. Pharmacokinetics (PK) of GSK1605786A

    The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.

    Measured: Baseline (Screening) and Week 12

  6. Pharmacogenetic Analyses

    Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.

    Measured: Post randomization any time during early two weeks

Timeline

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

  1. First posted22 Feb 2012 (estimated)
  2. Study start11 Nov 2011
  3. Primary completion17 Oct 2013
  4. Study completion17 Oct 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536418
Sponsor's protocol ID
114643
Acronym
SHIELD-4
Status last verified
Jan 2018
First submitted
16 Feb 2012
Last updated
29 Jan 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK1605786A in people with Crohn's Disease, run by GlaxoSmithKline at 227 sites in 31 countries.

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 39 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Germany, Japan, Israel, Spain and 26 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Aug 2017). 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?

Percentage of Participants Achieving Clinical Response at Week 12 (time frame: At Week 12). 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 NCT01536418.

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 29 Jan 2018.

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