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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
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GSK Investigational Site - Hersten
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GSK Investigational Site - Adelaide
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GSK Investigational Site - Kurralta Park
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GSK Investigational Site - Fitzroy
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GSK Investigational Site - Prahran
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GSK Investigational Site - Fremantle
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2200 - Bankstown
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4029 - Hersten
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5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
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3065 - Fitzroy
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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
This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.
Trial website
https://clinicaltrials.gov/study/NCT01277666
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01277666