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

• Register: EUCTR
• Last refreshed on: 14 April 2014
• Main ID: EUCTR2010-022384-35-DE
• Date of registration: 10/11/2010
• 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: 02/02/2011
• 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: no 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

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, 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. The information on the male sterility can come from the site personnel’s: review of subject’s medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
• 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 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
1. If female, is pregnant, has a positive pregnancy test or is breast-feeding, 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. Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
6. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies)
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.
8. 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.


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

Health Condition(s) or Problem(s) studied

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

Subjects with Crohn’s Disease
MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

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 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112.
12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112.
CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.

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 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112.
12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112.
CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.

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)

CCX114644

Source(s) of Monetary Support

GlaxoSmithKline Research & Development Ltd