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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01277666




Registration number
NCT01277666
Ethics application status
Date submitted
13/01/2011
Date registered
17/01/2011
Date last updated
19/09/2017

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
Scientific title
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
Secondary ID [1] 0 0
114151
Universal Trial Number (UTN)
Trial acronym
SHIELD-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1605786A
Treatment: Drugs - GSK1605786A
Treatment: Drugs - Placebo

Placebo comparator: Placebo - orally administered

Experimental: GSK1605786A 500mg once daily - orally administered

Experimental: GSK1605786A 500mg twice daily - orally administered


Treatment: Drugs: GSK1605786A
500 mg twice daily, administered orally for 12 weeks

Treatment: Drugs: GSK1605786A
500 mg once daily, administered orally for 12 weeks

Treatment: Drugs: Placebo
Placebo capsules, administered orally for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With CDAI Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12
Timepoint [2] 0 0
At Week 8 and 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12
Timepoint [3] 0 0
Week 8 and 12
Secondary outcome [4] 0 0
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8
Timepoint [4] 0 0
Week 8
Secondary outcome [5] 0 0
Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12
Timepoint [6] 0 0
Baseline (Week 0), Week 8 and Week 12
Secondary outcome [7] 0 0
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Timepoint [7] 0 0
Up to Week 12

Eligibility
Key inclusion criteria
* Male or female subjects aged 18 years or older
* Written informed consent
* Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
* 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
* History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
* Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
* Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers [elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin] at Screening
* Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
* Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
* 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 less than 1% for the duration of this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* If female: pregnant, has a positive pregnancy test or is breast-feeding
* Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
* Diagnosis of ulcerative or indeterminate colitis
* Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
* Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
* Extensive colonic resection, subtotal or total colectomy
* Presence of ileostomies, colostomies or rectal pouches
* Known fixed symptomatic stenoses
* History of more than 3 small bowel resections or diagnosis of short bowel syndrome
* Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
* Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames

1. Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
2. Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening
3. Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening
4. Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening
5. Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening
6. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening
7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
* Positive immunoassay for Clostridium difficile
* Known human immunodeficiency virus (HIV) infection
* Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
* Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine
* Active or latent tuberculosis infection
* Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
* Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH)
* Positive test for Hepatitis B or Hepatitis C antibody at screening
* Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
* Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study
* History or evidence of adenomatous colonic polyps that have not been removed
* History of evidence of colonic mucosal dysplasia
* 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)
* Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
* Medical history of sensitivity to any of the components of GSK1605786A
* Use of any investigational product within 30 days prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/07/2013
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Bankstown
Recruitment hospital [2] 0 0
GSK Investigational Site - Hersten
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Kurralta Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [6] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [7] 0 0
GSK Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
4029 - Hersten
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01277666