Phase 2 Crohn's Disease and Colitis Trial, Terminated NCT04677179 Sponsor: Nektar Therapeutics 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 (NCT04677179) tested an investigational drug called LY3471851 in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial ran across several phases — an induction period (initial treatment), a maintenance period, an extension period, and a follow-up period. In the first phase, 32 people received the high dose, 35 received the low dose, and 14 received a placebo (a dummy treatment with no active ingredient). Smaller numbers of participants continued into the later phases of the trial. The primary thing the trial was measuring was how many participants reached "clinical remission" at week 12 — meaning their bowel symptoms (stool frequency and bleeding) and a camera examination of the bowel had all returned to near-normal levels. The reported data shows that 17.2% of people in the high-dose group, 7.1% in the low-dose group, and 14.3% in the placebo group met this definition at week 12. For the secondary measures, the reported data shows that around 41% (high dose), 39% (low dose), and 36% (placebo) of participants showed a meaningful overall improvement in their disease score ("clinical response"). Regarding bowel camera findings specifically, 24% (high dose), 14% (low dose), and 29% (placebo) reached endoscopic remission, while 38% (high dose), 32% (low dose), and 21% (placebo) showed at least some improvement on camera ("endoscopic response"). For symptom-based measures, roughly 28% (high dose), 32% (low dose), and 21% (placebo) reached symptomatic remission, and around 45% (high dose), 43% (low dose), and 43% (placebo) showed a meaningful symptom improvement. It is worth noting that none of the trial periods recorded any participants formally completing those phases in the data as submitted — the reasons for this were not reported in the structured data provided. 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

NCT04677179
Terminated Phase 2 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • You have been diagnosed with moderately to severely active ulcerative colitis (UC), confirmed by a specific scoring system and a scope procedure (colonoscopy/endoscopy) done within 14 days before the study starts.
  • Your UC affects more than just the rectum — it extends further into the colon (at least 15 cm of the colon is involved).
  • You are up to date with your bowel cancer monitoring checks, as recommended in your area.
  • You have either tried standard treatments (such as steroids or certain immune-suppressing medicines) and they did not work or you could not tolerate them, OR you have tried one or more advanced treatments (such as biologics or JAK inhibitors) approved for UC and they did not work or caused problems.
  • You have had a confirmed diagnosis of UC for at least 3 months before the study starts, supported by results from a scope procedure and a tissue sample (biopsy) report.
  • If you are a woman who could become pregnant, you must have a negative pregnancy blood test at your first visit and a negative pregnancy urine test within 24 hours before taking the study drug.

Who may not be able to join:

  • You have been diagnosed with indeterminate colitis, proctitis (UC limited only to the rectum), or Crohn's disease.
  • You have recently used certain medicines for UC — including cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within the last 2 weeks, or steroid or 5-ASA treatments given rectally (such as enemas or suppositories) within the last 2 weeks.
  • You have already had, or are expected to need, surgery on your abdomen related to UC (for example, removal of part of the colon).
  • You have already tried and failed three or more different types of advanced therapies (such as biologics or JAK inhibitors) approved for UC.
  • You have signs of serious colon complications, such as a dangerously swollen colon (toxic megacolon), an abscess in the abdomen, or a narrowing in the small bowel or colon.
  • You have any history or current signs of cancer in the digestive tract.
  • You have had a heart attack, unstable heart disease, stroke, or heart failure in the 12 months before joining the study.

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 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Nektar Therapeutics

Australian sites

Concord Repatriation General Hospital, Concord, New South Wales
Paratus Clinical Research Brisbane, Albion, Queensland
Mater Adult Hospital Brisbane, South Brisbane, Queensland
St. Vincent's Hospital, Fitzroy, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Nektar Therapeutics
Registry
ClinicalTrials.gov
Start date
22 March 2021
Est. completion
9 August 2022

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇯🇵 Japan 🇱🇻 Latvia 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇰🇷 South Korea 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieved Clinical Remission at Week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 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