Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06850727 Sponsor: Odyssey Therapeutics Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06850727
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 a confirmed diagnosis of ulcerative colitis (UC)
  • People whose UC is considered moderate to severely active, based on a specific scoring system called the Modified Mayo clinic score
  • People whose UC did not respond well to, stopped responding to, or who could not tolerate at least one of the following treatments: certain anti-inflammatory medications taken by mouth (oral aminosalicylates), steroid medications (corticosteroids), immune-suppressing medications, or certain types of biologic or targeted therapies (including anti-TNF biologics, anti-IL-12/23 biologics, JAK inhibitors, or S1P modulators)

Who may not be able to join:

  • People who have been diagnosed with Crohn's disease or a condition called indeterminate colitis (a form of bowel inflammation that is not clearly identified as UC or Crohn's)
  • People who have had a large portion of their large bowel (colon) surgically removed
  • People who have a colostomy or ileostomy (a surgically created opening in the abdomen used to redirect waste out of the body)
  • People who have uncontrolled primary sclerosing cholangitis (a serious liver and bile duct condition that is not currently being managed)

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 22 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: Chief Medical Officer, Odyssey Therapeutics

Phone: 857-393-6160

Australian sites

Sunshine Coast University, Birtinya,
Eastern Health, Box Hill,
Coastal Digestive Health, Maroochydore,
Alfred Health, Melbourne,
Fiona Stanley Hospital, Murdoch,
Royal Melbourne Hospital, Parkville,

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
Odyssey Therapeutics
Registry
ClinicalTrials.gov
Start date
2 June 2025
Est. completion
1 April 2026

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇨🇿 Czechia 🇯🇴 Jordan 🇱🇹 Lithuania Moldova 🇳🇿 New Zealand 🇵🇱 Poland 🇺🇦 Ukraine

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

Primary endpoints

Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656; Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment

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: 22 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