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 (NCT03345849) looked at a medicine called upadacitinib (45 mg daily) compared to a placebo (an inactive treatment) in people with Crohn's disease. The first part of the trial ran for 12 weeks and included 176 people in the placebo group and 350 people in the upadacitinib group. A smaller second part ran from weeks 12 to 24, involving 57 and 59 participants respectively, though the results below focus on the 12-week findings. The trial measured three main things: whether participants reached a level of symptom control called "clinical remission" (assessed two different ways), and whether internal inflammation visible on a camera examination of the bowel had reduced by more than half (called "endoscopic response"). The reported data shows the following at the 12-week mark. For clinical remission measured by a symptom scoring tool called CDAI, 49.5% of people in the upadacitinib group reached that threshold, compared with 29.1% in the placebo group. When remission was measured using patients' own daily diary records of stool frequency and abdominal pain, 50.7% of the upadacitinib group met the target, versus 22.2% in the placebo group. For the bowel camera measurement, 45.5% in the upadacitinib group showed a meaningful reduction in visible inflammation, compared with 13.1% in the placebo group. On a secondary measure — a deeper level of bowel-camera improvement called "endoscopic remission" — 28.9% of the upadacitinib group met that threshold versus 7.4% in the placebo group. Among participants who were taking steroid medicines at the start, 42.9% in the upadacitinib group had stopped steroids and reached clinical remission by week 12, compared with 15.7% in the placebo group. Finally, on a 0–52 fatigue questionnaire (where higher scores mean less fatigue), the upadacitinib group's scores improved by an average of 11.3 points from their starting point, while the placebo group improved by 5.0 points on average. 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 ↗ · Read the linked publication on PubMed (PMID 41763462) ↗
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, Completed
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
- You have been diagnosed with Crohn's disease (CD) for at least 3 months before the study starts.
- Your Crohn's disease has been confirmed as moderate to severe, based on how often you have bowel movements and your level of abdominal pain.
- A camera test (endoscopy) has shown active inflammation in your gut, confirmed by an independent reviewer.
- Previous treatments for Crohn's disease — such as steroids, immune-suppressing medicines, or biologic therapies — have not worked well enough for you, or you were unable to tolerate them.
- If you previously tried a biologic therapy but stopped it for a reason other than it not working or causing side effects (for example, insurance changes or because your disease was under control), you may still be eligible (confirm with trial site).
- If you are a woman who could become pregnant, you must be willing to follow the trial's contraception requirements.
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.
- You have been diagnosed with ulcerative colitis or a form of colitis that doctors have not been able to clearly classify.
- You are not currently on a stable, consistent dose of certain Crohn's-related medicines, such as antibiotics, aminosalicylates, steroids, or methotrexate.
- You currently have serious complications from Crohn's disease, such as an abscess, a blocked bowel, severe colitis, a dangerously swollen colon, large sections of your bowel missing, or any condition that may require surgery during the study.
- You have had a stoma (ostomy bag) or a surgically created internal pouch.
- You have a condition that affects how your body absorbs medicine, such as short bowel syndrome.
- Your blood tests or other screening results come back with abnormal findings (confirm with trial site for specific details).
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: ABBVIE INC., AbbVie
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 With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12; Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12; Percentage of Participants With Endoscopic Response at Week 12
Other options
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.