A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

NCT01277666 | Completed Phase 3 Results DMC

• 1 other identifier: 114151
• Study Type: interventional
• Target: 608
• Locations: 22 countries
• Sites: 212

Brief Summary

This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

Conditions

Crohn's Disease

Keywords

Crohn's disease; capsule; GSK1605786A; quality of life; inflammatory bowel disease; oral therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12

  CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.

  Week 12

Secondary Outcomes (7)

• Percentage of Participants With CDAI Remission at Week 12

  Week 12

• Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12

  At Week 8 and 12

• Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12

  Week 8 and 12

• Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8

  Week 8

• Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8

  Week 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

orally administered

Drug: Placebo

GSK1605786A 500mg once daily

EXPERIMENTAL

orally administered

Drug: GSK1605786A

GSK1605786A 500mg twice daily

EXPERIMENTAL

orally administered

Drug: GSK1605786A

Interventions

GSK1605786A DRUG

500 mg twice daily, administered orally for 12 weeks

GSK1605786A 500mg twice daily

Placebo DRUG

Placebo capsules, administered orally for 12 weeks

Placebo

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
• Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
• Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry
• History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
• Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
• Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers \[elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin\] at Screening
• 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
• Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study

You may not qualify if:

• If female: pregnant, has a positive pregnancy test or is breast-feeding
• Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
• Diagnosis of ulcerative or indeterminate colitis
• Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
• Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
• Extensive colonic resection, subtotal or total colectomy
• Presence of ileostomies, colostomies or rectal pouches
• Known fixed symptomatic stenoses
• 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 medication
• Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames
• Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (219)

GSK Investigational Site

Little Rock, Arizona, 72205, United States

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GSK Investigational Site

Tucson, Arizona, 85712, United States

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GSK Investigational Site

Anaheim, California, 92801, United States

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GSK Investigational Site

Los Angeles, California, 90015, United States

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GSK Investigational Site

San Diego, California, 92103, United States

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GSK Investigational Site

San Francisco, California, 94115, United States

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GSK Investigational Site

Lakewood, Colorado, 80215, United States

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GSK Investigational Site

Littleton, Colorado, 80120, United States

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GSK Investigational Site

Hamden, Connecticut, 06518, United States

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GSK Investigational Site

Jacksonville, Florida, 32207, United States

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GSK Investigational Site

Jacksonville, Florida, 32256-6004, United States

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GSK Investigational Site

Maitland, Florida, 32751, United States

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GSK Investigational Site

Port Orange, Florida, 32127, United States

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GSK Investigational Site

Atlanta, Georgia, 30342-5006, United States

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GSK Investigational Site

Chicago, Illinois, 60637, United States

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GSK Investigational Site

Oak Lawn, Illinois, 60453, United States

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Indianapolis, Indiana, 46237, United States

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Lexington, Kentucky, 40536-0298, United States

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Hammond, Louisiana, 70403, United States

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GSK Investigational Site

Monroe, Louisiana, 71201, United States

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GSK Investigational Site

Chevy Chase, Maryland, 20815, United States

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GSK Investigational Site

Towson, Maryland, 21204, United States

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GSK Investigational Site

Boston, Massachusetts, 02114, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109-5048, United States

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GSK Investigational Site

Chesterfield, Michigan, 48047, United States

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GSK Investigational Site

Troy, Michigan, 48098, United States

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GSK Investigational Site

Rochester, Minnesota, 55905, United States

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Jackson, Mississippi, 39202, United States

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GSK Investigational Site

Tupelo, Mississippi, 38801, United States

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GSK Investigational Site

Lee's Summit, Missouri, 64064, United States

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GSK Investigational Site

Lebanon, New Hampshire, 03756, United States

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GSK Investigational Site

Egg Harbor City, New Jersey, 08234, United States

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GSK Investigational Site

Voorhees Township, New Jersey, 08043, United States

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GSK Investigational Site

Great Neck, New York, 11021, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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Raleigh, North Carolina, 27612, United States

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GSK Investigational Site

Columbus, Ohio, 43215, United States

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Tulsa, Oklahoma, 74135, United States

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GSK Investigational Site

Portland, Oregon, 97225, United States

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GSK Investigational Site

Germantown, Tennessee, 38138, United States

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GSK Investigational Site

Nashville, Tennessee, 37212-1610, United States

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GSK Investigational Site

Austin, Texas, 78745, United States

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GSK Investigational Site

Houston, Texas, 77034-0550, United States

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GSK Investigational Site

Pasadena, Texas, 77505, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Seattle, Washington, 98101, United States

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GSK Investigational Site

Seattle, Washington, 98195, United States

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GSK Investigational Site

Bankstown, New South Wales, 2200, Australia

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GSK Investigational Site

Hersten, Queensland, 4029, Australia

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Kurralta Park, South Australia, 5037, Australia

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GSK Investigational Site

Fitzroy, Victoria, 3065, Australia

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GSK Investigational Site

Prahran, Victoria, 3181, Australia

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GSK Investigational Site

Fremantle, Western Australia, 6160, Australia

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GSK Investigational Site

Hall in Tirol, 6060, Austria

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GSK Investigational Site

Linz, A-4021, Austria

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Vienna, 1050, Austria

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GSK Investigational Site

Vienna, 1090, Austria

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GSK Investigational Site

Bonheiden, 2820, Belgium

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GSK Investigational Site

Brussels, 1000, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Kortrijk, 8500, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Roeselare, 8800, Belgium

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GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

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GSK Investigational Site

Edmonton, Alberta, T6G 2X8, Canada

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Abbotsford, British Columbia, V2S 3N5, Canada

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GSK Investigational Site

Vancouver, British Columbia, V6Z 2K5, Canada

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GSK Investigational Site

Victoria, British Columbia, V8V 3M9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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GSK Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

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GSK Investigational Site

Hamilton, Ontario, L8N 4A6, Canada

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Hamilton, Ontario, L8S 4K1, Canada

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GSK Investigational Site

Kingston, Ontario, K7L 5G2, Canada

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GSK Investigational Site

London, Ontario, N6A 5A5, Canada

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GSK Investigational Site

London, Ontario, N6A 5W9, Canada

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GSK Investigational Site

Ottawa, Ontario, K1H 1A2, Canada

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GSK Investigational Site

Richmond Hill, Ontario, L4B 3P8, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

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GSK Investigational Site

Lévis, Quebec, G6V 3Z1, Canada

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GSK Investigational Site

Montreal, Quebec, H3A 1A1, Canada

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GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

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GSK Investigational Site

Québec, Quebec, G1S 4L8, Canada

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GSK Investigational Site

Québec, Quebec, G3K 2P8, Canada

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GSK Investigational Site

Brno, 625 00, Czechia

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GSK Investigational Site

Hradec Králové, 500 12, Czechia

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GSK Investigational Site

Olomouc, 77520, Czechia

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GSK Investigational Site

Ostrava - Vitkovice, 70384, Czechia

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GSK Investigational Site

Prague, 100 34, Czechia

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GSK Investigational Site

Prague, 140 21, Czechia

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GSK Investigational Site

Prague, 17004, Czechia

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GSK Investigational Site

Prague, 190 61, Czechia

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GSK Investigational Site

Aalborg, 9000, Denmark

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GSK Investigational Site

Aarhus, 8000, Denmark

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GSK Investigational Site

Herlev, 2730, Denmark

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GSK Investigational Site

Hvidovre, 2650, Denmark

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GSK Investigational Site

Odense, 5000, Denmark

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GSK Investigational Site

Amiens, 80054, France

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GSK Investigational Site

Clichy, 92118, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Nantes, 44093, France

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GSK Investigational Site

Nice, 06202, France

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GSK Investigational Site

Paris, 75475, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Saint-Priest-en-Jarez, 42270, France

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GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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GSK Investigational Site

Ulm, Baden-Wurttemberg, 89081, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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GSK Investigational Site

Braunschweig, Lower Saxony, 38126, 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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GSK Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

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GSK Investigational Site

Minden, North Rhine-Westphalia, 32423, Germany

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GSK Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

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GSK Investigational Site

Münster, North Rhine-Westphalia, 48159, Germany

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GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

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GSK Investigational Site

Dessau, Saxony-Anhalt, 06847, Germany

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GSK Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

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GSK Investigational Site

Jena, Thuringia, 07747, Germany

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GSK Investigational Site

Berlin, 10117, Germany

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Berlin, 12157, Germany

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GSK Investigational Site

Berlin, 13353, Germany

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GSK Investigational Site

Hamburg, 20148, Germany

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GSK Investigational Site

Hamburg, 22559, Germany

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GSK Investigational Site

Békéscsaba, 5600, Hungary

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GSK Investigational Site

Budapest, 1088, Hungary

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GSK Investigational Site

Szekszárd, 7100, Hungary

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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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GSK Investigational Site

Petah Tikva, 49100, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

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GSK Investigational Site

Palermo, Sicily, 90127, Italy

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GSK Investigational Site

Genova, 16132, Italy

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GSK Investigational Site

Modena, 41100, Italy

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GSK Investigational Site

Roma, 00152, Italy

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GSK Investigational Site

Roma, 00168, Italy

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GSK Investigational Site

Aichi, 460-0012, Japan

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GSK Investigational Site

Aichi, 466-8560, Japan

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GSK Investigational Site

Chiba, 285-8741, Japan

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GSK Investigational Site

Fukuoka, 812-8582, Japan

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GSK Investigational Site

Fukuoka, 818-8502, Japan

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GSK Investigational Site

Hokkaido, 060-0033, 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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GSK Investigational Site

Kagoshima, 892-8512, Japan

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GSK Investigational Site

Miyagi, 981-3213, Japan

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GSK Investigational Site

Osaka, 530-0011, Japan

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GSK Investigational Site

Osaka, 545-8586, Japan

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GSK Investigational Site

Tokyo, 113-8519, Japan

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GSK Investigational Site

Tokyo, 160-8582, Japan

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GSK Investigational Site

Tokyo, 169-0073, Japan

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GSK Investigational Site

Almere Stad, 1315 RA, 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

Heerlen, 6419 PC, Netherlands

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GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

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GSK Investigational Site

Auckland, 1148, New Zealand

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Dunedin, 9054, New Zealand

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GSK Investigational Site

Hamilton, 3204, New Zealand

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GSK Investigational Site

Lower Hutt, 6007, New Zealand

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GSK Investigational Site

Otahuhu, 1640, New Zealand

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GSK Investigational Site

Tauranga, 3143, New Zealand

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GSK Investigational Site

Ålesund, 6017, Norway

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GSK Investigational Site

Bodø, 8005, Norway

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Oslo, N-0456, Norway

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GSK Investigational Site

Tromsø, 9038, Norway

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GSK Investigational Site

Trondheim, 7030, Norway

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GSK Investigational Site

Tønsberg, 3116, Norway

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GSK Investigational Site

Bydgoszcz, 85-168, Poland

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Bydgoszcz, 85-681, Poland

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Elblag, 82-300, Poland

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Lublin, 20-607, Poland

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GSK Investigational Site

Sopot, 81-756, Poland

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GSK Investigational Site

Torun, 87-100, Poland

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GSK Investigational Site

Wroclaw, 53-333, Poland

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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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GSK Investigational Site

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

Bellville, 7530, South Africa

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GSK Investigational Site

Claremont, 7708, South Africa

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GSK Investigational Site

Observatory, 7925, South Africa

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GSK Investigational Site

Parktown, 2192, South Africa

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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, 130-702, South Korea

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GSK Investigational Site

Seoul, 135-230, 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

Galdakao/Vizcaya, 48960, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Sabadell (Barcelona), 08208, Spain

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GSK Investigational Site

Gothenburg, SE-416 85, Sweden

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GSK Investigational Site

Lund, SE-221 85, Sweden

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GSK Investigational Site

Stockholm, SE-171 76, Sweden

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GSK Investigational Site

Stockholm, SE-182 88, Sweden

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GSK Investigational Site

Umeå, SE-901 85, Sweden

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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

Bristol, BS2 8HW, United Kingdom

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GSK Investigational Site

Edinburgh, EH4 2XU, 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

Nottingham, NG7 2UH, United Kingdom

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GSK Investigational Site

Oxford, OX3 9DU, United Kingdom

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GSK Investigational Site

Salford, M6 8HD, United Kingdom

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MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

CCX282-B

Condition Hierarchy (Ancestors)

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: January 13, 2011
• First Posted: January 17, 2011
• Study Start: December 20, 2010
• Primary Completion: July 11, 2013
• Study Completion: July 11, 2013
• Last Updated: September 19, 2017
• Results First Posted: September 19, 2017

Record last verified: 2017-07

Locations

DE (19); JP (15); HU (3); DK (5); US (48); AU (4); SL (7); ZA (4); NZ (6); GB (9); IL (7); IT (5); BE (8); KR (6); ES (5); NL (6); CZ (8); NO (6); SE (5); CA (20); FR (9); PL (7)