Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT07012395 Sponsor: Spyre Therapeutics, Inc. Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT07012395
Recruiting 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:

  • People who have been diagnosed with ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine) for at least 3 months before the study start date, confirmed by a camera examination of the bowel and tissue samples taken either before or during the screening period
  • People whose ulcerative colitis is active and affects a section of the bowel starting at least 15 centimetres from the back passage, as confirmed by a camera examination during screening (a small proportion of participants — up to around 15% — may have disease limited only to the rectum)
  • People whose disease is rated as moderately to severely active, based on specific scoring tools that measure symptoms such as rectal bleeding and the appearance of the bowel lining during the camera examination

Who may not be able to join:

  • People who have been diagnosed with Crohn's disease or a type of inflammatory bowel disease that doctors have not been able to clearly classify
  • People who have, or are suspected to have, severe life-threatening inflammation of the colon, a dangerously enlarged colon, a hole in the bowel wall, or other conditions that are likely to require surgery during the early treatment phase
  • People who have already tried four or more different classes of advanced treatments for their condition (whether approved or investigational) without success

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 6 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: SKYLINE-UC Study Director, Spyre Therapeutics

Phone: 1-650-402-4238

Australian sites

Site 208, Concord,
Site 202, Heidelberg,
Site 204, Liverpool,
Site 203, Melbourne,
Site 206, South Brisbane,
Site 207, Woolloongabba,

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
Recruiting
Phase
Phase 2
Sponsor
Spyre Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
27 May 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇯🇴 Jordan 🇱🇹 Lithuania 🇲🇽 Mexico Moldova 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇺🇸 United States

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

Primary endpoints

Part A: Change in Robarts Histopathology Index (RHI); Part B: Percentage of participants with clinical remission

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: 6 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