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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01536418




Registration number
NCT01536418
Ethics application status
Date submitted
16/02/2012
Date registered
22/02/2012
Date last updated
29/01/2018

Titles & IDs
Public title
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
Scientific title
A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease
Secondary ID [1] 0 0
114643
Universal Trial Number (UTN)
Trial acronym
SHIELD-4
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

Experimental: GSK1605786A, 500 milligrams, once daily - 500 milligrams once daily, orally administered for 12 weeks

Experimental: GSK1605786A, 500 milligrams twice daily - 500 milligrams twice daily, orally administered for 12 weeks


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

Treatment: Drugs: GSK1605786A
500 milligrams twice daily, orally adminstered for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12
Timepoint [1] 0 0
Week 8 and Week 12
Secondary outcome [2] 0 0
Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12
Timepoint [2] 0 0
Both Week 8 and Week 12
Secondary outcome [3] 0 0
Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12
Timepoint [3] 0 0
Baseline (Screening) and Weeks 4, 8, and Week 12
Secondary outcome [4] 0 0
Change From Baseline in Faecal Calprotectin at Week 12
Timepoint [4] 0 0
Baseline (Screening) and Week 12
Secondary outcome [5] 0 0
Pharmacokinetics (PK) of GSK1605786A
Timepoint [5] 0 0
Baseline (Screening) and Week 12
Secondary outcome [6] 0 0
Pharmacogenetic Analyses
Timepoint [6] 0 0
Post randomization any time during early two weeks

Eligibility
Key inclusion criteria
* Male or female subjects aged 18 years or older
* Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications
* Diagnosis of Crohn's disease for more than 4 months with small bowel and/or colonic involvement
* Current evidence of moderately-to-severely active disease defined by a baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive
* Confirmation of active disease by elevated CRP (greater than or equal to the upper limit of normal for the highly sensitive C-reactive protein test) or elevated levels of faecal calprotectin
* History of inadequate response and/or intolerance or adverse event leading to discontinuation of at least one of the following treatments for Crohn's disease: corticosteroids or immunosuppressants
* 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
* Female subjects of child-bearing potential are eligible if not pregnant or nursing and committed to use of contraceptive methods with a failure rate of less than 1 percent per year
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)
* Diagnosis of ulcerative or indeterminate colitis
* Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
* Bowel surgery, other than appendectomy, within 12 weeks prior to screening and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period
* Extensive colonic resection, subtotal or total colectomy
* Presence of ileostomies, colostomies or rectal pouches
* Fixed symptomatic stenoses of small bowel or colon
* 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 medicaitons
* Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study. Prohibited medications include the following:

1. Biologic use: Use of any TNF inhibitor (such as infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to Randomisation
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. Enteral feeding: Use of tube or enteral feeding, elemental diet within 2 weeks prior to Screening
6. Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks prior to Screening
7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to Screening
8. Paracetamol or acetaminophen greater than 2 grams per day
9. Opioid analgesics for worsening Crohn's disease pain are prohibited when used on a regular daily basis for more than 3 days
10. Digoxin or related cardiac glycosides: Use within 7 days prior to Screening
11. Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
* Positive immunoassay for Clostridium difficile
* Known HIV infection
* Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
* Immunization with a live vaccine within 4 weeks of Screening and throughout the study with the exception of the influenza vaccine
* Positive hepatitis B surface antigen or hepatitis B core antibody test or positive Hepatitis C test result at Screening
* Active or latent tuberculosis infection determined by results of QuantiFERON TB Gold test
* Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
* Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise
* Evidence of hepatic dysfunction, viral hepatitis, or abnormalities in liver function test results
* Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
* Congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection
* 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)
* History of evidence of adenomatous colonic polyps that have not been removed.
* History of evidence of colonic mucosal dysplasia
* If female, is pregnant, has a positive pregnancy test or is breast-feeding
* Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (such as an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)
* Medical history of sensitivity to any of the components of GSK1605786A (microcrystalline cellulose, crospovidone, sodium stearyl fumarate).
* 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2013
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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GSK Investigational Site - Bankstown
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GSK Investigational Site - Adelaide
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GSK Investigational Site - Box Hill
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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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5000 - Adelaide
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3128 - Box Hill
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3065 - Fitzroy
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3181 - Prahran
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6160 - Fremantle
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index \[CDAI\] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.
Trial website
https://clinicaltrials.gov/study/NCT01536418
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/NCT01536418