Clinical Trials Register

Summary
EudraCT Number:	2010-022382-10
Sponsor's Protocol Code Number:	CCX114151
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-10-29
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

Netherlands - Competent Authority

A.2

EudraCT number

2010-022382-10

A.3

Full title of the trial

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

A.4.1

Sponsor's protocol code number

CCX114151

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Information not present in EudraCT
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.3.9.3	Other descriptive name	N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with Moderately-to-Severely Active Crohn’s Disease

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease

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 efficacy of GSK1605786A compared with placebo as an induction
therapy in subjects with moderately-to-severely active Crohn’s disease over 12
weeks.

E.2.2

Secondary objectives of the trial

To evaluate the safety of GSK1605786A compared with placebo in subjects with
moderately-to-severely active Crohn’s disease
• To investigate the effect of GSK1605786A compared with placebo on health related
quality of life in subjects with moderately-to-severely active Crohn’s disease
• To investigate the effect of GSK1605786A compared with placebo on healthcare
related resource utilisation in subjects with moderately-to-severely active Crohn’s
disease
• To explore the dose relationships between GSK1605786A plasma concentration and
clinical response endpoints
• To explore potential relationships between genetic variants and GSK1605786A
efficacy and safety endpoints.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subjects aged ≥18 years
2. Written informed consent prior to any of the screening procedures including
discontinuation of prohibited medications
3. A diagnosis of Crohn’s disease for > 4 months duration with small bowel and/or
colonic involvement
4. Confirmation of Crohn’s disease established by visualisation of the gastrointestinal
tract within the 12 months prior to screening or by screening endoscopy at study
entry. Acceptable methods for gastrointestinal tract visualisation include, but are not
limited to endoscopy, capsule endoscopy, MRI or barium X-ray. Subjects without
visualisation of the gastrointestinal tract within 12 months of screening must be
willing to undergo endoscopy within the screening period
5. History of inadequate response and/or intolerance/adverse event leading to
discontinuation of at least one of the following treatments for Crohn’s disease:
corticosteroids, immunosuppressants
6. Current evidence of moderately-to-severely active disease characterised by a CDAI
score of ≥220 to ≤450 at Baseline (Week 0) [Criterion for Randomisation]
7. Confirmation of current active Crohn’s disease by either of the following [Criterion
for Randomisation]:
a. Luminal ulceration visualised by Screening endoscopy and as adjudicated by
central endoscopy reader, or
b. Elevated CRP (>ULN) plus elevated faecal calprotectin (> 200 μg/g stool) at
Screening
Note: Subjects who fail to meet criterion 7b) may qualify if criterion 7a) is met. If
7b) is met and investigator elects to perform an endoscopy within the screening
period which is subsequently adjudicated as negative, then the subject is excluded.
8. Stable doses of permitted concomitant medications or having previously received,
but are not currently receiving, medications for Crohn’s disease. Please refer to
Section 5.5.1 Permitted Medications and Non Drug Therapies.
9. Demonstrated ability to comply with Crohn’s disease symptom recording using the
IVRS; to be eligible for randomisation subject must complete recording of symptoms
for at least 8 consecutive days prior to the randomisation/baseline visit (Week 0).
10. 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 a failure rate of < 1% for the duration of this study as defined by the following:
Abstinence
Sexual inactivity by abstinence must be consistent with the preferred and usual
lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception.
Contraceptive Methods with a Failure Rate of < 1%
• Oral contraceptive, either combined or progestogen alone
• Injectable progestogen
• Implants of 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 sterilisation (vasectomy with documentation of azoospermia) prior
to the female subject's entry into the study, and this male is the sole partner for
that subject. For this definition, “documented” refers to the outcome of the
investigator's/designee’s medical examination of the subject or review of the
subject's medical history for study eligibility, as obtained via a verbal interview
with the subject or from the subject’s medical records.
• Double barrier method: condom and occlusive cap (diaphragm or cervical/vault
caps) plus spermicidal agent (foam/gel/film/cream/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.
• A serum pregnancy test is required of all females of child-bearing potential. In
addition, a urine pregnancy test will be performed on the morning of
randomisation visit (Week 0) and at Weeks 4, 8 and 12.
Country specific inclusion criterion for subjects in France: A subject will be eligible
for inclusion in this study only if either affiliated to or a beneficiary of a social security
category.

E.4

Principal exclusion criteria

1. If female, is pregnant, has a positive pregnancy test or is breast-feeding
2. Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac
disease (elevated anti- tissue transglutaminase antibodies)
3. Diagnosis of ulcerative or indeterminate colitis
4. Known or suspected small bowel stricture
5. Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to
require surgery during the study period
6. Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for CD during the study period
7. Extensive colonic resection, subtotal or total colectomy
8. Presence of ileostomies, colostomies or rectal pouches
9. Known fixed symptomatic stenoses
10. History of more than 3 small bowel resections or diagnosis of short bowel syndrome
11. Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
12. Use of prohibited medications, including enteral feeding or elemental diet, within
their specified timeframes (Section 5.5.2 Prohibited Medications and Non Drug
Therapies).
• Biologic use: Use of any TNF inhibitor (eg. infliximab, adalimumab or
certolizumab) or natalizumab within 8 weeks prior to screening
• Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to
screening
• Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or
mycophenolate mofetil within 4 weeks prior to screening
• Intravenous antibiotic use: Use of intravenous antibiotics for Crohn’s disease
within 4 weeks prior to screening
• Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories
within 2 weeks prior to screening
• Use of tube or enteral feeding, elemental diet, or parenteral alimentation within
2 weeks prior to screening
• Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
13. Positive immunoassay for C. difficile [Subjects who test positive and receive
antibiotic treatment may be re-screened after 4 months the re-test is negative]
14. Known HIV infection
15. Known varicella, herpes zoster, or other severe viral infection within 6 weeks of
screening
16. Subjects who have received immunisation with a live vaccine e.g. measles,
mumps, rubella (each as in MMR vaccine), oral polio, varicella, yellow fever,
within 4 weeks of screening, with the exception of influenza vaccine
17. Active or latent tuberculosis (TB) infection: All subjects will be tested with
QuantiFERON TB Gold test and those with positive test result will be excluded.
View protocol for further information.
18. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
19. Previous infections characterised by opportunistic pathogens, and/or
dissemination suggestive of clinically significant immunocompromise
20. The subject has congenital or acquired immunodeficiency or has evidence of
immunocompromise manifested by current opportunistic infection.
21. The subject exhibits evidence of hepatic dysfunction, viral hepatitis or increases in ALT(SGPT)/AST(SGOT)/alkaline phosphase/bilirubin above pre-defined thresholds. See protocol for further information.
22. A positive HBsAg or Anti-HBc test or positive Hepatitis C antibody result at screening
23. QTc ≥450 msec (480 msec for those with Bundle Branch Block)
24. The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)
25. History or evidence of adenomatous colonic polyps that have not been removed
26. History of evidence of colonic mucosal dysplasia
27. The subject has current evidence of, or has been treated for a malignancy within
the past five years (other than localised basal cell, squamous cell skin cancer,
cervical dysplasia, or any cancer in situ that has been resected)
28. Any previous participation in a clinical study of GSK1605786A (formerly
ChemoCentryx compound CCX282-B)
29. Medical history of sensitivity to any of the components of GSK1605786A
(microcrystalline cellulose, crospovidone, sodium stearyl fumarate).
30. Use of any investigational product within 30 days prior to screening.

E.5 End points

E.5.1

Primary end point(s)

• Proportion of subjects achieving clinical response, defined by CDAI decrease from
baseline of ≥100 points, at Week 12

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3

Other

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

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

Information not present in EudraCT

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

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.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

280

F.4.2.2

In the whole clinical trial

600

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects who are a responder (CDAI decrease =>100 points) or in remission (CDAI < 150 points) at the Week 12 are eligible to enter a 52 week maintenance study (Study CCX114157). Other subjects who complete the Week 12 assessment are eligible for the open-label extension study (Study CCX114644). Subjects who do not enter either CCX114157 or CCX114644 will return for a follow-up visit at Week 16. Subsequent treatment for Crohn’s disease will be at the discretion of the investigator.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-02-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-07-11

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IMP with orphan designation in the indication
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