GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

NCT01316939 | Terminated Phase 3 Results DMC

• 2 other identifiers: 1141572010-022383-12
• Study Type: interventional
• Target: 229
• Locations: 31 countries
• Sites: 245

Brief Summary

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 in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

Conditions

Crohn's Disease

Keywords

Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Clinical Remission (Crohn's Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period

  Clinical remission is defined as a CDAI score \<150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.

  Week 28 and 52

Secondary Outcomes (24)

• Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period

  Week 28 and 52

• Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline

  Week 28 and 52

• Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline

  Upto Week 52

• Percentage of Participants in Clinical Remission at Week 52

  Week 52

• Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period

  Week 28 and 52

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

GSK1605786A once daily

EXPERIMENTAL

500 milligrams once daily

Drug: GSK1605786A

GSK1605786A twice daily

EXPERIMENTAL

500 milligrams twice daily

Drug: GSK1605786A

Interventions

GSK1605786A DRUG

GSK1605786A 500 milligrams once daily

GSK1605786A once daily

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study
• Written informed consent prior to any CCX114157 specific study procedures
• Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent
• Stable doses of Crohn's disease medications
• Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study

You may not qualify if:

• If female, is pregnant, has a positive pregnancy test or is breast-feeding
• Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
• Known or suspected fixed symptomatic small bowel stricture
• Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
• Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks
• Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (256)

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

La Jolla, California, 92093, 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

Aurora, Colorado, 80045, 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

New Haven, Connecticut, 06510, United States

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GSK Investigational Site

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

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GSK Investigational Site

Jacksonville, Florida, 32256-6004, 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

Suwanee, Georgia, 30024, United States

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GSK Investigational Site

Chicago, Illinois, 60637, United States

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GSK Investigational Site

Indianapolis, Indiana, 46237, United States

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GSK Investigational Site

Lexington, Kentucky, 40536-0298, United States

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GSK Investigational Site

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

Towson, Maryland, 21286, United States

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GSK Investigational Site

Boston, Massachusetts, 02114, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109-5682, 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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GSK Investigational Site

Lee's Summit, Missouri, 64064, United States

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GSK Investigational Site

Mexico, Missouri, 65265-3726, United States

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GSK Investigational Site

Brooklyn, New York, 11206, United States

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GSK Investigational Site

East Setauket, New York, 11733-9292, United States

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GSK Investigational Site

Great Neck, New York, 11021, United States

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GSK Investigational Site

Lake Success, New York, 11042, United States

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GSK Investigational Site

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

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GSK Investigational Site

Charlotte, North Carolina, 28207, United States

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GSK Investigational Site

Charlotte, North Carolina, 28209, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Raleigh, North Carolina, 27612, United States

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GSK Investigational Site

Columbus, Ohio, 43215, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74135, United States

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GSK Investigational Site

Portland, Oregon, 97225, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15212, 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

Ogden, Utah, 84405, United States

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GSK Investigational Site

Christiansburg, Virginia, 24073, United States

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GSK Investigational Site

Danville, Virginia, 24541, United States

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GSK Investigational Site

Norfolk, Virginia, 23502, United States

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GSK Investigational Site

Richmond, Virginia, 23249, 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

Madison, Wisconsin, 53792, United States

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GSK Investigational Site

Milwaukee, Wisconsin, 53226, 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

Box Hill, Victoria, 3128, 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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GSK Investigational Site

Oberpullendorf, 7350, Austria

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GSK Investigational Site

St.Veit/Glan, 9300, Austria

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GSK Investigational Site

Vienna, 1030, Austria

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GSK Investigational Site

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

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

Plovdiv, 4002, Bulgaria

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GSK Investigational Site

Sofia, 1407, Bulgaria

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GSK Investigational Site

Sofia, 1431, Bulgaria

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GSK Investigational Site

Sofia, 1527, Bulgaria

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GSK Investigational Site

Varna, 9010, Bulgaria

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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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GSK Investigational Site

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

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 3Z5, Canada

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GSK Investigational Site

Hamilton, Ontario, L8N 4A6, 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

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

Viña del Mar, 2520012, Chile

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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, 2605, Denmark

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GSK Investigational Site

Odense, 5000, Denmark

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GSK Investigational Site

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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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

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

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

Minden, North Rhine-Westphalia, 32423, Germany

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GSK Investigational Site

Berlin, 10117, 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

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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GSK Investigational Site

Budapest, 1083, Hungary

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GSK Investigational Site

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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GSK Investigational Site

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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GSK Investigational Site

Petah Tikva, 49100, Israel

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GSK Investigational Site

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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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

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

Hiroshima, 720-8520, 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, 160-8582, Japan

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GSK Investigational Site

Tokyo, 169-0073, Japan

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GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

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GSK Investigational Site

Amsterdam, 1091 AC, Netherlands

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GSK Investigational Site

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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GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

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GSK Investigational Site

Rotterdam, 3083 AN, Netherlands

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GSK Investigational Site

Dunedin, 9054, New Zealand

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GSK Investigational Site

Lower Hutt, 6007, New Zealand

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GSK Investigational Site

Otahuhu, Auckland, 2025, New Zealand

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GSK Investigational Site

Tauranga, 3143, New Zealand

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GSK Investigational Site

Tromsø, 9038, 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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GSK Investigational Site

Bydgoszcz, 85-681, Poland

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GSK Investigational Site

Lublin, 20-582, 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

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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GSK Investigational Site

Kazan', 420064, Russia

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GSK Investigational Site

Lipetsk, 398055, Russia

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GSK Investigational Site

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, 197047, Russia

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GSK Investigational Site

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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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, 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

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 (Cantabria), 39008, Spain

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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

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

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, 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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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

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

Interventions

CCX282-B

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.

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: March 3, 2011
• First Posted: March 16, 2011
• Study Start: May 9, 2011
• Primary Completion: October 23, 2013
• Study Completion: October 23, 2013
• Last Updated: September 7, 2017
• Results First Posted: September 7, 2017

Record last verified: 2017-08

Locations

NL (7); GB (8); CL (1); DE (9); ES (11); NZ (4); PL (6); SL (7); JP (14); DK (5); BU (5); CA (16); SE (3); US (54); CH (2); TU (1); PT (4); AU (7); FR (8); RU (10); CZ (7); IT (5); KR (7); UA (9); NO (2); BE (7); HU (8); IL (11); ZA (4); TW (1); HK (2)