Clinical Trials Register

Summary
EudraCT Number:	2010-022384-35
Sponsor's Protocol Code Number:	CCX114644
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-27
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2010-022384-35

A.3

Full title of the trial

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Open label extension study

A.4.1

Sponsor's protocol code number

CCX114644

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Research & Development Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GlaxoSmithKline Research & Development Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Research & Development Ltd
B.5.2	Functional name of contact point	Clincial Trials HelpDesk
B.5.3	Address:
B.5.3.1	Street Address	Iron Bridge Road
B.5.3.2	Town/ city	Uxbridge
B.5.3.3	Post code	UB11 1BU
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+440208990 44 66
B.5.5	Fax number	+440208990 12 34
B.5.6	E-mail	GSKClincialSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	GSK1605786A
D.3.2	Product code	GSK1605786A
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	GSK1605786A
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with Crohn’s Disease

E.1.1.1

Medical condition in easily understood language

Crohn’s disease Inflammatory bowel disease

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

E.2.2

Secondary objectives of the trial

• 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.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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. 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. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies)
7. 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.

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.

E.5 End points

E.5.1

Primary end point(s)

Safety Primary Endpoints:

Incidence of adverse events/Serious adverse events

E.5.1.1

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).

E.5.2

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.

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

154

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Austria

Brazil

Bulgaria

Chile

Estonia

Greece

Hong Kong

Ireland

Israel

Italy

Korea, Republic of

New Zealand

Portugal

Russian Federation

Slovakia

Spain

Switzerland

Taiwan

Turkey

Ukraine

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Subject Last Visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.1.1