Open-Label Extension Study of GSK1605786A

NCT01318993 | Terminated Phase 3 Results DMC

• 2 other identifiers: 1146442010-022384-35
• Study Type: interventional
• Target: 399
• Locations: 29 countries
• Sites: 234

Brief Summary

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

Conditions

Crohn's Disease

Keywords

GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)

  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take \>=1 dose of investigational product.

  Up to Week 112

Secondary Outcomes (12)

• Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period

  Baseline (Week 0) and up to Week 112

• Change From Baseline (Week 0) in Heart Rate (HR) Over Period

  Baseline (week 0) and up to Week 112

• Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters

  Baseline (Week 0) and up to Week 112

• Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters

  Baseline (Week 0) and up to Week 112

• Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)

  Baseline (Week 0) and up to Week 112

Study Arms (1)

GSK1605786A

EXPERIMENTAL

500 milligrams twice daily

Drug: GSK1605786A

Interventions

GSK1605786A DRUG

500 milligrams twice daily

GSK1605786A

Eligibility Criteria

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

You may qualify if:

• Previous participation in a GSK-sponsored study with GSK1605786A
• Written informed consent prior to any study-specific procedures
• Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate

You may not qualify if:

• If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
• Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
• Fixed symptomatic stenoses or strictures of small bowel or colon
• Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
• Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
• Evidence of hepatic dysfunction or viral hepatitis
• Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (244)

GSK Investigational Site

Little Rock, Arizona, 72205, United States

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Tucson, Arizona, 85712, United States

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Anaheim, California, 92801, United States

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La Jolla, California, 92093, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80045, United States

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Lakewood, Colorado, 80215, 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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Atlanta, Georgia, 30342-5006, United States

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Suwanee, Georgia, 30024, United States

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Chicago, Illinois, 60637, 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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Monroe, Louisiana, 71201, United States

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Chevy Chase, Maryland, 20815, United States

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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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Ann Arbor, Michigan, 48109-5682, United States

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Chesterfield, Michigan, 48047, United States

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Troy, Michigan, 48098, 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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East Setauket, New York, 11733-9292, United States

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Great Neck, New York, 11021, United States

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Lake Success, New York, 11042, United States

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Chapel Hill, North Carolina, 27599-7080, United States

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Charlotte, North Carolina, 28207, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Raleigh, North Carolina, 27612, 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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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37212-1610, 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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Seattle, Washington, 98101, United States

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GSK Investigational Site

Seattle, Washington, 98195, 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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Hersten, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Kurralta Park, South Australia, 5037, 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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Vienna, 1050, Austria

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Vienna, 1090, Austria

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Bonheiden, 2820, Belgium

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Brussels, 1000, Belgium

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Brussels, 1200, 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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Calgary, Alberta, T2N 4Z6, Canada

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Edmonton, Alberta, T6G 2X8, Canada

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Abbotsford, British Columbia, V2S 3N5, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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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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Ottawa, Ontario, K1H 1A2, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1S 4L8, Canada

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Québec, Quebec, G3K 2P8, Canada

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GSK Investigational Site

Viña del Mar, 2520012, Chile

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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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Prague, 100 34, Czechia

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Prague, 140 21, Czechia

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Prague, 17004, Czechia

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Prague, 190 61, 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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Hvidovre, 2605, Denmark

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Odense, 5000, Denmark

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Tallinn, 10617, Estonia

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Tallinn, EE-10138, Estonia

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Tartu, 51014, Estonia

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Clichy, 92118, France

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Lille, 59037, France

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Nantes, 44093, France

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Nice, 06202, France

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Paris, 75475, France

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Pessac, 33604, France

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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

Ulm, Baden-Wurttemberg, 89081, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Hanover, Lower Saxony, 30625, Germany

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Minden, North Rhine-Westphalia, 32423, Germany

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Berlin, 10117, Germany

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Berlin, 13353, Germany

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Hamburg, 20148, Germany

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Hamburg, 22559, Germany

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Hong Kong, Hong Kong

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Shatin, New Territories, Hong Kong

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Békéscsaba, 5600, Hungary

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Budapest, 1062, Hungary

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Budapest, 1083, Hungary

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Budapest, 1136, Hungary

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Debrecen, 4025, Hungary

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GSK Investigational Site

Mosonmagyaróvár, 9200, Hungary

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Szekszárd, 7100, Hungary

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Vác, 2600, Hungary

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Afula, 18101, Israel

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Beersheba, 84101, Israel

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Haifa, 31096, Israel

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Holon, 58100, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Tel Aviv, 64239, Israel

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Ẕerifin, 70300, Israel

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Genoa, Liguria, 16132, Italy

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Palermo, Sicily, 90127, Italy

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Modena, 41100, Italy

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Roma, 00152, Italy

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Aichi, 460-0012, Japan

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Chiba, 285-8741, Japan

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GSK Investigational Site

Fukuoka, 812-8582, Japan

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Fukuoka, 818-8502, Japan

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Hiroshima, 720-8520, Japan

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Hokkaido, 060-0033, Japan

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Hyōgo, 663-8501, Japan

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Kagoshima, 892-0846, Japan

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Kagoshima, 892-8512, Japan

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Miyagi, 981-3213, Japan

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Osaka, 530-0011, Japan

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Osaka, 545-8586, Japan

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Tokyo, 160-8582, Japan

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Tokyo, 169-0073, Japan

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Dunedin, 9054, New Zealand

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Lower Hutt, 6007, New Zealand

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Otahuhu, Auckland, 2025, New Zealand

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Tauranga, 3143, New Zealand

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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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Torun, 87-100, Poland

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Wroclaw, 53-333, Poland

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Lisbon, 1649-035, Portugal

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Lisbon, 1769-001, Portugal

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Porto, 4099-001, Portugal

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Viseu, 3504-509, Portugal

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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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Nizhny Novgorod, 603126, Russia

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Rostov-on-Don, 344091, Russia

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Saint Petersburg, 196247, Russia

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GSK Investigational Site

Saint Petersburg, 197047, Russia

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Samara, 443011, Russia

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Tomsk, 634063, Russia

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Bratislava, 831 04, Slovakia

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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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Trnava, 917 02, Slovakia

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Bellville, 7530, South Africa

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Claremont, 7708, South Africa

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Observatory, 7925, South Africa

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Parktown, 2192, South Africa

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Busan, South Korea

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GSK Investigational Site

Daegu, 705-717, 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, 135710, 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

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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Marbella, 29600, Spain

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GSK Investigational Site

Sabadell (Barcelona), 08208, Spain

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Santander, 39008, Spain

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Lund, SE-221 85, Sweden

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Stockholm, SE-171 76, Sweden

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Stockholm, SE-182 88, Sweden

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Bern, 3004, Switzerland

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Zurich, 8091, Switzerland

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GSK Investigational Site

Taichung, 40705, Taiwan

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GSK Investigational Site

Ankara, 06100, Turkey (Türkiye)

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Chernivtsi, 58005, Ukraine

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GSK Investigational Site

Dnipropetrovsk, 49044, Ukraine

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GSK Investigational Site

Donetsk, 83003, Ukraine

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GSK Investigational Site

Donetsk, 83017, Ukraine

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GSK Investigational Site

Kharkiv, 61037, Ukraine

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GSK Investigational Site

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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Harrow, Middlesex, HA1 3UJ, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Bristol, BS2 8HW, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Manchester, M13 9WL, United Kingdom

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GSK Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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Oxford, OX3 9DU, United Kingdom

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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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 29, 2013
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-07

Locations

PT (4); AU (8); BE (7); CH (2); NZ (4); IT (4); ZA (4); CL (1); ES (10); DE (8); TU (1); HK (2); JP (14); RU (9); SL (7); HU (8); IL (11); TW (1); US (55); PL (6); KR (7); SE (3); BU (5); CZ (7); DK (5); UA (9); CA (16); FR (8); GB (8)