🏛️ Verified NIH Record • Updated 2026-02-09

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis (NCT06850727)

A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Odyssey Therapeutics

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.

Who can join: Review the eligibility criteria below.

Location: Sunshine Coast University — Birtinya

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (32 Sites)

Showing the first 25 of 32 sites.

  • Sunshine Coast University — Birtinya,
  • Eastern Health — Box Hill,
  • Coastal Digestive Health — Maroochydore,
  • Alfred Health — Melbourne,
  • Fiona Stanley Hospital — Murdoch,
  • Royal Melbourne Hospital — Parkville,
  • Medical University of Graz — Graz,
  • CHUM — Montreal,
  • Montreal General Hospital/McGill University — Montreal,
  • CHUM - Pavillon R — Polička,
  • Jordan University Hospital — Amman,
  • The Specialty Hospital (TSH) / Advanced Clinical Center — Amman,
  • Irbid Specialty Hospital — Irbid,
  • The Hospital of Lithuanian University of Health Sciences — Kaunas,
  • IMSP Spitalul Clinic Republican Timofei Moneaga — Chisinau,
  • PCRN Auckland — Auckland,
  • PCRN Christchurch — Christchurch,
  • PCRN Waikato — Hamilton,
  • PCRN Tasman — Nelson,
  • PCRN Wellington — Upper Hutt,
  • Centrum Medyczne — Bydgoszcz,
  • Centrum Medyczne LukaMed — Chojnice,
  • Vita Longa Sp. z.o.o. — Katowice,
  • Centrum Medyczne Medyk — Rzeszów,
  • Endoskopia Sp. z.o.o — Sopot,

📞 Contact the Study Coordinator

Phone: (857) 393-6160

Email: clinicaltrials@odysseytx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗