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

NCT01536418 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 114643
• Study Type: interventional
• Target: 255
• Locations: 29 countries
• Sites: 210

Brief 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. 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease, chemokine receptor 9 antagonist, Crohn's Disease Activity Index; active treatment

Outcome Measures

Primary Outcomes (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.

  At Week 12

Secondary Outcomes (6)

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

  Week 8 and Week 12

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

  Both Week 8 and Week 12

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

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

• Change From Baseline in Faecal Calprotectin at Week 12

  Baseline (Screening) and Week 12

• Pharmacokinetics (PK) of GSK1605786A

  Baseline (Screening) and Week 12

Study Arms (2)

GSK1605786A, 500 milligrams, once daily

EXPERIMENTAL

500 milligrams once daily, orally administered for 12 weeks

Drug: GSK1605786A

GSK1605786A, 500 milligrams twice daily

EXPERIMENTAL

500 milligrams twice daily, orally administered for 12 weeks

Drug: GSK1605786A

Interventions

GSK1605786A DRUG

500 milligrams once daily, orally administered for 12 weeks

GSK1605786A, 500 milligrams, once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (227)

GSK Investigational Site

Little Rock, Arizona, 72205, United States

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Tucson, Arizona, 85712, United States

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La Jolla, California, 92037, United States

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Aurora, Colorado, 80045, United States

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GSK Investigational Site

Denver, Colorado, 80222, United States

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Littleton, Colorado, 80120, United States

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Hamden, Connecticut, 06518, United States

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New Haven, Connecticut, 06510, United States

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Washington D.C., District of Columbia, 20007, United States

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Jacksonville, Florida, 32256-6004, United States

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Port Orange, Florida, 32127, United States

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Suwanee, Georgia, 30024, United States

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Chicago, Illinois, 60637, United States

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Chevy Chase, Maryland, 20815, United States

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GSK Investigational Site

Towson, Maryland, 21204, United States

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Towson, Maryland, 21286, United States

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Boston, Massachusetts, 02114, United States

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Chesterfield, Michigan, 48047, United States

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Rochester, Minnesota, 55905, United States

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Lee's Summit, Missouri, 64064, United States

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Mexico, Missouri, 65265-3726, United States

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Brooklyn, New York, 11206, United States

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Lake Success, New York, 11042, United States

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Stony Brook, New York, 11794, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28207, United States

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GSK Investigational Site

Charlotte, North Carolina, 28209, United States

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Columbus, Ohio, 43215, United States

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Tulsa, Oklahoma, 74135, United States

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Portland, Oregon, 97225, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78745, United States

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Ogden, Utah, 84405, United States

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Christiansburg, Virginia, 24073, United States

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Danville, Virginia, 24541, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23249, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53226, United States

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Bankstown, New South Wales, 2200, Australia

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Adelaide, South Australia, 5000, Australia

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Box Hill, Victoria, 3128, Australia

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Fitzroy, Victoria, 3065, Australia

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Prahran, Victoria, 3181, Australia

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Fremantle, Western Australia, 6160, Australia

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Hall in Tirol, 6060, Austria

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Linz, A-4021, Austria

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Oberpullendorf, 7350, Austria

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St.Veit/Glan, 9300, Austria

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Vienna, 1030, Austria

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GSK Investigational Site

Vienna, 1050, Austria

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Vienna, 1090, Austria

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Bonheiden, 2820, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Plovdiv, 4002, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9010, Bulgaria

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Kingston, Ontario, K7L 5G2, Canada

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London, Ontario, N6A 5A5, Canada

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London, Ontario, N6A 5W9, Canada

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Viña del Mar, 2520012, Chile

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Hradec Králové, 500 12, Czechia

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Olomouc, 77520, Czechia

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Prague, 140 59, Czechia

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Prague, 190 61, Czechia

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Teplice, 415 29, Czechia

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Ústí nad Orlicí, 562 18, Czechia

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Aalborg, 9000, Denmark

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Aarhus, 8000, Denmark

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Herlev, 2730, Denmark

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Koebenhavn NV, 2400, Denmark

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Tallinn, 10617, Estonia

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GSK Investigational Site

Tallinn, EE-10138, Estonia

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GSK Investigational Site

Tartu, 51014, Estonia

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GSK Investigational Site

Clichy, 92118, France

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Lille, 59037, France

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Paris, 75475, France

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GSK Investigational Site

Saint-Priest-en-Jarez, 42270, France

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GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

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GSK Investigational Site

Weiden, Bavaria, 92637, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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Brinkum/Stuhr, Lower Saxony, 28816, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

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Rostock, Mecklenburg-Vorpommern, 18057, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Minden, North Rhine-Westphalia, 32423, Germany

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GSK Investigational Site

Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39120, Germany

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GSK Investigational Site

Jena, Thuringia, 07747, Germany

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Berlin, 10117, Germany

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GSK Investigational Site

Hamburg, 20148, Germany

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GSK Investigational Site

Athens, 10676, Greece

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GSK Investigational Site

Athens, 11522, Greece

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GSK Investigational Site

Athens, 18454, Greece

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GSK Investigational Site

Heraklion, Crete, 71110, Greece

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GSK Investigational Site

Ioannina, 45110, Greece

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GSK Investigational Site

Hong Kong, Hong Kong

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GSK Investigational Site

Shatin, New Territories, Hong Kong

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GSK Investigational Site

Békéscsaba, 5600, Hungary

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GSK Investigational Site

Budapest, 1062, Hungary

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Budapest, 1083, Hungary

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Budapest, 1088, Hungary

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Budapest, 1136, Hungary

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GSK Investigational Site

Debrecen, 4025, Hungary

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GSK Investigational Site

Mosonmagyaróvár, 9200, Hungary

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GSK Investigational Site

Szekszárd, 7100, Hungary

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GSK Investigational Site

Vác, 2600, Hungary

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GSK Investigational Site

Afula, 18101, Israel

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Beersheba, 84101, Israel

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GSK Investigational Site

Haifa, 31096, Israel

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GSK Investigational Site

Holon, 58100, Israel

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GSK Investigational Site

Jerusalem, 91031, Israel

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GSK Investigational Site

Jerusalem, 91120, Israel

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GSK Investigational Site

Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

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GSK Investigational Site

Ẕerifin, 70300, Israel

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Genova, 16132, Italy

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GSK Investigational Site

Aichi, 441-8570, Japan

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Aichi, 460-0012, Japan

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GSK Investigational Site

Aichi, 470-1219, Japan

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GSK Investigational Site

Fukuoka, 802-0077, Japan

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GSK Investigational Site

Fukuoka, 818-8502, Japan

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GSK Investigational Site

Fukuoka, 830-0011, Japan

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GSK Investigational Site

Hiroshima, 720-8520, Japan

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GSK Investigational Site

Hokkaido, 065-0033, Japan

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GSK Investigational Site

Hyōgo, 663-8501, Japan

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GSK Investigational Site

Kagoshima, 892-0846, Japan

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Kanagawa, 220-0045, Japan

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GSK Investigational Site

Kanagawa, 247-0056, Japan

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GSK Investigational Site

Osaka, 530-0011, Japan

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GSK Investigational Site

Shizuoka, 430-0846, Japan

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Tokyo, 169-0073, Japan

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Wakayama, 641-8510, Japan

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GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1091 AC, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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GSK Investigational Site

Ede, 6716 RP, Netherlands

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GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

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Rotterdam, 3083 AN, Netherlands

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GSK Investigational Site

Canterbury, 8011, New Zealand

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GSK Investigational Site

Dunedin, 9054, New Zealand

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Hamilton, 3204, New Zealand

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GSK Investigational Site

Lower Hutt, 6007, New Zealand

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Otahuhu, 1640, New Zealand

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GSK Investigational Site

Takapuna, Auckland, 1309, New Zealand

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GSK Investigational Site

Tauranga, 3143, New Zealand

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GSK Investigational Site

Bydgoszcz, 85-168, Poland

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Bydgoszcz, 85-681, Poland

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Lublin, 20-607, Poland

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Sopot, 81-756, Poland

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GSK Investigational Site

Wroclaw, 53-333, Poland

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GSK Investigational Site

Lisbon, 1649-035, Portugal

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GSK Investigational Site

Lisbon, 1769-001, Portugal

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GSK Investigational Site

Porto, 4099-001, Portugal

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GSK Investigational Site

Viseu, 3504-509, Portugal

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GSK Investigational Site

Irkutsk, 664079, Russia

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Kazan', 420064, Russia

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Lipetsk, 398055, Russia

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Moscow, 129110, Russia

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GSK Investigational Site

Nizhny Novgorod, 603126, Russia

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GSK Investigational Site

Rostov-on-Don, 344091, Russia

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GSK Investigational Site

Saint Petersburg, 196247, Russia

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GSK Investigational Site

Saint Petersburg, 197110, Russia

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Samara, 443011, Russia

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GSK Investigational Site

Tomsk, 634063, Russia

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GSK Investigational Site

Bratislava, 831 04, Slovakia

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GSK Investigational Site

Bratislava, 851 01, Slovakia

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Bratislava, 851 07, Slovakia

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GSK Investigational Site

Nitra, 949 01, Slovakia

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GSK Investigational Site

Nové Mesto nad Váhom, 915 01, Slovakia

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GSK Investigational Site

Prešov, 080 01, Slovakia

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GSK Investigational Site

Trnava, 917 02, Slovakia

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GSK Investigational Site

Daegu, 705-717, South Korea

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GSK Investigational Site

Pusan, 602-739, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Seoul, 130702, South Korea

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GSK Investigational Site

Seoul, 135-230, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Wŏnju, 220701, South Korea

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Elche, 03293, Spain

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GSK Investigational Site

Fuenlabrada (Madrid), 28942, Spain

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GSK Investigational Site

Galdakao/Vizcaya, 48960, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Marbella, 29600, Spain

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GSK Investigational Site

Sabadell (Barcelona), 08208, Spain

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GSK Investigational Site

Santander, 39008, Spain

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Bern, 3004, Switzerland

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GSK Investigational Site

Zurich, 8091, Switzerland

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GSK Investigational Site

Taichung, 40705, Taiwan

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GSK Investigational Site

Taipei, 100, Taiwan

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GSK Investigational Site

Taipei, 104, Taiwan

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GSK Investigational Site

Taoyuan District, 333, Taiwan

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GSK Investigational Site

Ankara, 06100, Turkey (Türkiye)

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GSK Investigational Site

Chernivtsi, 58005, Ukraine

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GSK Investigational Site

Dnipropetrovsk, 49044, Ukraine

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GSK Investigational Site

Donetsk, 83017, Ukraine

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GSK Investigational Site

Donetsk, 83099, Ukraine

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GSK Investigational Site

Kharkiv, 61037, Ukraine

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Kyiv, Ukraine

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GSK Investigational Site

Odesa, 65117, Ukraine

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GSK Investigational Site

Simferopol, 95017, Ukraine

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GSK Investigational Site

Vinnytsia, 21029, Ukraine

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GSK Investigational Site

Glasgow, Lanarkshire, G4 0SF, United Kingdom

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GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

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GSK Investigational Site

Birmingham, B9 5SS, United Kingdom

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GSK Investigational Site

Dundee, DD1 9SY, United Kingdom

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GSK Investigational Site

Edinburgh, EH4 2XU, United Kingdom

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GSK Investigational Site

London, E1 2AT, United Kingdom

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GSK Investigational Site

Manchester, M13 9WL, United Kingdom

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GSK Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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GSK Investigational Site

Oxford, OX3 9DU, United Kingdom

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MeSH Terms

Conditions

Crohn Disease

Interventions

CCX282-B

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: November 11, 2011
• Primary Completion: October 17, 2013
• Study Completion: October 17, 2013
• Last Updated: January 29, 2018
• Results First Posted: August 17, 2017

Record last verified: 2018-01

Locations

FR (4); NL (6); PT (4); TU (1); HK (2); IL (11); DK (4); AU (7); BU (5); ES (3); NZ (7); SL (7); KR (7); GB (9); CL (1); HU (9); US (40); CH (2); TW (4); CA (3); GR (5); JP (16); UA (9); BE (6); IT (1); RU (10); PL (5); DE (16); CZ (6)