Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 253 adults with moderately-to-severely active Crohn's disease — a chronic inflammatory bowel condition. Participants were split into two groups: 127 people received a drug called GSK1605786A at a dose of 500 mg once daily, and 126 received the same drug at 500 mg twice daily. The trial was primarily measuring whether participants' Crohn's disease symptoms improved noticeably by Week 12, using a scoring system called the CDAI (Crohn's Disease Activity Index), which rates disease severity based on things like bowel habits, abdominal pain, and general wellbeing. It is worth noting the trial was stopped early — the reported data states this was due to an absence of a favourable benefit-to-risk profile for the drug. The reported data shows that at Week 12, about 25% of participants in the once-daily group and about 33% in the twice-daily group showed a meaningful reduction in their CDAI score (a drop of 100 points or more), which the trial defined as a "clinical response." For the secondary measures, the reported data shows that at Week 12, approximately 12% of the once-daily group and 18% of the twice-daily group reached what the trial called "clinical remission" (a CDAI score below 150, indicating low disease activity). At the earlier Week 8 check, around 24% (once daily) and 29% (twice daily) showed a clinical response. Some additional measurements — including blood and stool markers of inflammation, and drug levels in the blood — were not collected because the trial was terminated early, so that data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Terminated
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults aged 18 or older, of any gender
- People who are willing and able to provide written consent before any screening steps begin, including stopping any medications that are not allowed in the trial
- People who have been diagnosed with Crohn's disease for more than 4 months, with the disease affecting the small bowel and/or the colon
- People whose Crohn's disease is currently moderately to severely active, based on a standard disease activity scoring tool called the CDAI (score between 220 and 450)
- People with blood or stool test results that confirm active inflammation (elevated CRP or elevated faecal calprotectin)
- People who have previously tried at least one Crohn's disease treatment — either corticosteroids or immunosuppressants — and did not respond well enough, or had to stop due to side effects
- People who are either on stable doses of allowed medications, or who have used Crohn's medications in the past but are not currently taking them
- People who are able to record their Crohn's disease symptoms regularly using a phone-based system provided by the trial
- Women of childbearing age who are not pregnant or breastfeeding, and who commit to using a highly effective form of contraception (with a failure rate of less than 1% per year) throughout the trial
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have been diagnosed with coeliac disease, follow a gluten-free diet to manage symptoms of suspected coeliac disease, or have a positive screening test for coeliac disease
- People diagnosed with ulcerative colitis or indeterminate colitis (a related but different bowel condition)
- People who have fistulas (abnormal connections from the bowel) involving the skin, abdomen, or pelvis that are accompanied by abscesses, or that are likely to need surgery during the trial period
- People who have had bowel surgery (other than appendix removal) within the 12 weeks before screening, or who are planning or likely to need bowel surgery during the trial
- People who have had a large portion of their colon surgically removed, including subtotal or total removal
- People who have a stoma bag (ileostomy or colostomy) or a rectal pouch
- People who have a fixed, symptom-causing narrowing in the small bowel or colon
- People who have had more than three small bowel surgeries, or who have been diagnosed with short bowel syndrome
- People who use narcotic (opioid) pain medications every day
- People who have recently used certain medications that are not permitted in the trial, including:
- Certain biologic treatments such as infliximab, adalimumab, certolizumab, or natalizumab within 10 weeks before the start of the trial
- Steroid injections or infusions within 4 weeks before screening
- Certain immune-suppressing drugs (cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil) within 4 weeks before screening
- Intravenous (IV) antibiotics for Crohn's disease within 4 weeks before screening
- Tube feeding or elemental (liquid nutritional) diets within 2 weeks before screening
- Rectal treatments such as enemas or suppositories containing steroids or 5-aminosalicylates within 2 weeks before screening
- A procedure called leukocytapheresis or granulocytapheresis within 2 weeks before screening
- More than 2 grams per day of paracetamol (acetaminophen)
- Opioid pain relievers used daily for more than 3 days in a row for worsening Crohn's pain
- Digoxin or related heart medications within 7 days before screening
- Previous participation in a clinical trial of the study drug GSK1605786A (also known as CCX282-B)
- People who test positive for a gut infection called Clostridium difficile
- People with a known HIV infection
- People who have had chickenpox, shingles, or another serious viral infection within 6 weeks of screening
- People who have received a live vaccine within 4 weeks of screening (flu vaccines are an exception)
- People who test positive for hepatitis B or hepatitis C at screening
- People with active or latent (hidden) tuberculosis, based on a specific blood test (QuantiFERON TB Gold)
- People with a current serious infection requiring IV antibiotics for more than 2 weeks
- People who have previously had serious infections caused by unusual (opportunistic) pathogens, suggesting a significantly weakened immune system
- People with signs of liver disease or abnormal liver function test results
- People with a specific abnormality on a heart tracing (ECG) — specifically a corrected QT interval of 450 milliseconds or more
- People who have an inherited or acquired immune system deficiency, or who currently have an opportunistic infection
- People who have been diagnosed with or treated for cancer within the past five years (exceptions may apply for certain minor skin cancers, cervical changes, or cancers that have been fully removed — confirm with trial site)
- People who have a history of abnormal colon growths (adenomatous polyps) that have not been removed
- People who have a history of abnormal cell changes (dysplasia) in the lining of the colon
- Women who are pregnant, have a positive pregnancy test, or are breastfeeding
- People with another ongoing illness or condition that could affect the reliability of trial results or make participation unsafe — such as unstable heart, kidney, liver, lung, hormonal, blood, nerve, or mental health conditions (confirm with trial site)
- People who have a known sensitivity or allergy to any of the ingredients in the study drug (microcrystalline cellulose, crospovidone, or sodium stearyl fumarate)
- People who have taken part in any other clinical drug trial within 30 days before screening
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: GSK Clinical Trials, GlaxoSmithKline
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants Achieving Clinical Response at Week 12
Other options
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.