A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2010-022384-35-BG
• Date of registration: 28/05/2013
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research & Development Ltd
• Public title: A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease
• Scientific title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study
• Date of first enrolment: 13/06/2013
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022384-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clincial Trials HelpDesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: Clincial Trials HelpDesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Previous participation in a GSK-sponsored study with GSK1605786A as follows:
a. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI => 100 point decrease) or clinical remission (CDAI < 150) at Week 12 or completion of other GSK-sponsored induction studies, with the exception of Study CCX114643, as designated by the sponsor
b. completion of maintenance study CCX114157 at Week 52
c. withdrawal from maintenance study CCX114157 due to worsening of Crohn’s disease and requiring a treatment change
2. Written informed consent prior to any CCX114644-specific study procedures
3. Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following: Contraceptive Methods with a Failure Rate of < 1%
• Abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle
• Oral contraceptive, either combined or progestogen alone
• Injectable progestogen
• Implants of etonogestrel or levonorgestrel
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
• Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
• Male condom combined with a vaginal spermicide (foam, gel, film,
cream, or suppository)
• Male condom combined with a female diaphragm, either with or
without a vaginal spermicide (foam, gel, film, cream, or suppository)
These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 766
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion criteria:
1. If female, is pregnant, has a positive pregnancy test or is breastfeeding, or is planning to become pregnant
2. Subjects with known or suspected coeliac disease or a positive screening test for antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive test result.
3. Fixed symptomatic stenoses of small bowel or colon
4. Infection requiring intravenous antibiotic therapy >2 weeks
5. Subjects who have been withdrawn early from study CCX114157 due to disease worsening and have received, or are currently receiving, rescue treatment with any of the following interventions shall be excluded from entry into study CCX114644: (a) Any biologic, including
investigational agents, for the treatment of Crohn's disease. Prohibited agents include, but are not limited to TNF inhibitors and other biologic therapies (e.g.: infliximab, adalimumab, certolizumab or natalizumab, vedolizumab and ustekinumab); (b) The following immunosuppressants: azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus,
sirolimus, thalidomide, mycophenolate mofetil, janus kinase inhibitors; (c) Bowel resection surgery.
6. The subject exhibits evidence of hepatic dysfunction or viral hepatitis; has serum ALT (SGPT) and/or AST (SGOT) values ?2 times the upper limit of normal, a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), or alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); or has known hepatic or biliary abnormalities with the exception of Gilbert's syndrome or asymptomatic gallstones.
7. 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.
In order to ensure continuity of study treatment, subjects will begin treatment at baseline prior to receiving results of LFTs or anti-tTG antibody test (if applicable). If the results of these tests indicate that the subject has met these exclusion criteria, the subject should be withdrawn from the study, recorded as a screen failure and withdrawn due to inability to meet study continuation criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with Crohn’s Disease
MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: GSK1605786A
Product Code: GSK1605786A
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GSK1605786A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Secondary Objective: • To assess the effectiveness of long-term treatment with GSK1605786A
• To assess changes in health-related quality of life
• To assess changes in healthcare-related resource utilisation
• To assess changes in work productivity and activity impairment
• To assess changes in unemployment and disability rates
• To assess changes in C-reactive protein (CRP) as a biomarker of
inflammation
• To potentially evaluate the correlation of genetic markers with the safety and effectiveness of GSK1605786A.

Main Objective: To assess the safety and tolerability of long-term treatment with GSK1605786A in subjects with Crohn’s disease.

Timepoint(s) of evaluation of this end point: Safety assessments at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216 and 220 (follow up).
12 lead ECG at Week 24, 48, 72, 108, 144, 180, 216 and 220 (Follow Up).
CDAI assessments at Week 12, 24, 36, 48, 60, 72, 84, 96, 108 120, 132, 144, 156, 168, 180, 192, 204, 216 and 220 (Follow Up).

Primary end point(s): Safety Primary Endpoints:

Incidence of adverse events/Serious adverse events

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Safety assessments at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216 and 220 (follow up).
12 lead ECG at Week 24, 48, 72, 108, 144, 180, 216 and 220 (Follow Up).
CDAI assessments at Week 12, 24, 36, 48, 60, 72, 84, 96, 108 120, 132, 144, 156, 168, 180, 192, 204, 216 and 220 (Follow Up).

Secondary end point(s): • Change from baseline in vital signs: heart rate and blood pressure.
• Change from baseline in haematology and clinical chemistry parameters.
• Change from baseline in liver function test parameters.
• Change from baseline in 12 lead ECG abnormalities.

Secondary ID(s)

2010-022384-35-DE

CCX114644

Source(s) of Monetary Support

GlaxoSmithKline Research & Development Ltd