A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01277666
• Date of registration: 13/01/2011
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• 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 SHIELD-1
• 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
• Date of first enrolment: December 20, 2010
• Target sample size: 608
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01277666
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: GSK1605786A

Drug: Placebo

Primary Outcome(s)

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8 [Time Frame: Week 8]

Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8 [Time Frame: Week 8]

Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Time Frame: Up to Week 12]

Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12 [Time Frame: Week 8 and 12]

Percentage of Participants With CDAI Remission at Week 12 [Time Frame: Week 12]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12 [Time Frame: Baseline (Week 0), Week 8 and Week 12]

Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12 [Time Frame: At Week 8 and 12]

Secondary ID(s)

114151

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01277666