Phase 2 Crohn's Disease and Colitis Trial, Terminated NCT03635112 Sponsor: Theravance Biopharma Condition: Crohn's Disease and Colitis
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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 (NCT03635112) enrolled 159 adults with Crohn's disease across three groups: 38 people received a placebo (a dummy treatment with no active ingredient), 58 received a lower dose of the investigational drug TD-1473 (80 mg), and 63 received a higher dose (200 mg). The trial primarily measured changes in a scoring system called the Crohn's Disease Activity Index (CDAI) — a scale from 0 to 600 that combines symptoms such as abdominal pain, bowel movements, and general wellbeing, where a higher score means more severe disease. Scores below 150 are considered to indicate remission (no active disease). The reported data shows that all three groups had lower CDAI scores after 12 weeks compared to where they started. The placebo group's score dropped by an average of about 105 points, the 80 mg group's by about 106 points, and the 200 mg group's by about 118 points. For the secondary measures, 19 placebo participants, 28 in the 80 mg group, and 34 in the 200 mg group met the definition of "clinical response" (a drop of at least 100 points or a score below 150). Remission at 12 weeks (a CDAI score under 150) was reported in 13 placebo participants, 13 in the 80 mg group, and 22 in the 200 mg group. When bowel lining was examined by camera (endoscopy), a measurable improvement was seen in 6 placebo participants, 5 in the 80 mg group, and 15 in the 200 mg group. A combined measure of reduced stool frequency and abdominal pain showed remission in 6, 6, and 10 participants across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 2 Crohn's Disease and Colitis Trial, Terminated

NCT03635112
Terminated Phase 2 🇦🇺 Australian site

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 are at least 18 years old at the time of screening
  • You are male or female and have been diagnosed with Crohn's disease for at least 3 months before screening
  • Your Crohn's disease is considered moderately to severely active, based on a specific scoring system used by doctors (called the CDAI, with a score between 220 and 450)
  • A camera examination of your bowel shows a certain level of ulceration (open sores) in at least one section of your intestine, confirmed by a specific scoring tool (confirm with trial site)
  • You either depend on steroid medication to manage your symptoms, or previous treatments have not worked well enough or caused you problems — this includes common Crohn's treatments and/or biological medicines

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 are currently being treated with a type of biological medicine (such as anti-TNF, anti-integrin, or anti-IL-12/23 therapies)
  • You currently have an active infection caused by bacteria, parasites, fungi, or a virus
  • Your recent blood or lab test results show significant abnormalities (confirm with trial site)
  • You have previously taken, or may have been exposed to, a type of medicine called a JAK inhibitor that was stopped because it did not work or caused side effects
  • You have taken part in another clinical trial involving an experimental drug or device within the past 30 days (or longer, depending on the drug), or you are currently in another such trial
  • You have already tried and not responded to 3 or more different types of biological medicines, each working in a different way

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Trial contact details on record

Principal Investigator: Medical Monitor, Theravance Biopharma

Australian sites

Theravance Biopharma Investigational Site, Bankstown, New South Wales
Theravance Biopharma Investigational Site, Elizabeth Vale, South Australia
Theravance Biopharma Investigational Site, Perth, Western Australia

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

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Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Theravance Biopharma
Registry
ClinicalTrials.gov
Start date
19 November 2018
Est. completion
30 December 2021

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇭🇷 Croatia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov