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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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114643
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Universal Trial Number (UTN)
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Trial acronym
SHIELD-4
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Response at Week 12
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Assessment method [1]
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Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.
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Timepoint [1]
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At Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12
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Assessment method [1]
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Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission.
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Timepoint [1]
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Week 8 and Week 12
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Secondary outcome [2]
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Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12
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Assessment method [2]
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Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.
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Timepoint [2]
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Both Week 8 and Week 12
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Secondary outcome [3]
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Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12
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Assessment method [3]
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Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.
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Timepoint [3]
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Baseline (Screening) and Weeks 4, 8, and Week 12
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Secondary outcome [4]
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Change From Baseline in Faecal Calprotectin at Week 12
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Assessment method [4]
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Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.
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Timepoint [4]
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Baseline (Screening) and Week 12
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Secondary outcome [5]
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Pharmacokinetics (PK) of GSK1605786A
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Assessment method [5]
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The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.
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Timepoint [5]
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Baseline (Screening) and Week 12
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Secondary outcome [6]
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Pharmacogenetic Analyses
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Assessment method [6]
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Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.
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Timepoint [6]
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Post randomization any time during early two weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/10/2013
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Sample size
Target
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Accrual to date
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Final
255
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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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 - Prahran
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GSK Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3181 - Prahran
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Recruitment postcode(s) [6]
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6160 - Fremantle
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Recruitment outside Australia
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Afula
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Country [80]
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Israel
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State/province [80]
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Beer Sheva
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Israel
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Haifa
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Country [82]
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Genova
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Aichi
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Japan
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Fukuoka
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Japan
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Daegu
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju
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Netherlands
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Amsterdam
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Netherlands
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EDE
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Netherlands
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Eindhoven
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Netherlands
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Rotterdam
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Canterbury
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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Country [112]
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New Zealand
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Lower Hutt
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Country [113]
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New Zealand
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Otahuhu
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New Zealand
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Takapuna, Auckland
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New Zealand
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Tauranga.
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Poland
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Bydgoszcz
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Poland
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Lublin
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Poland
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Sopot
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Poland
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Viseu
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Russian Federation
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Irkutsk
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Russian Federation
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Kazan
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Russian Federation
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Lipetsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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St.Petersburg
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Russian Federation
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Tomsk
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Country [133]
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Country [135]
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Slovakia
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Nove Mesto nad Vahom
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Slovakia
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Presov
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Slovakia
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Trnava
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Country [138]
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Spain
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Badalona
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Country [139]
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Spain
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Elche
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Country [140]
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Spain
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Fuenlabrada (Madrid)
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Country [141]
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Spain
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Galdakao/Vizcaya
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Spain
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Madrid
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Country [143]
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Spain
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Marbella
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Country [144]
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Spain
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Spain
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Bern
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Taoyuan
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Turkey
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Ukraine
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Ukraine
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Simferopol
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Country [159]
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Ukraine
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Vinnytsya
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Country [160]
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United Kingdom
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Lanarkshire
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Country [161]
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United Kingdom
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Middlesex
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Country [162]
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United Kingdom
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Birmingham
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Country [163]
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United Kingdom
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Dundee
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Country [164]
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01536418
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01536418
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