OD-07656 + Vedolizumab for Ulcerative Colitis

Recruiting at 32 trial locations

Overseen By Head of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Odyssey Therapeutics

Disqualifiers: Crohn's disease, Colostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OD-07656 for individuals with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation and ulcers in the colon. Researchers aim to determine if OD-07656 is effective on its own and whether it enhances the effectiveness of vedolizumab, a biologic therapy. Participants will take OD-07656 orally twice a day in various dosing schedules. Suitable candidates have UC that hasn't improved with other treatments, such as certain pills or injections. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that in a previous study, OD-07656 was tested on healthy adults to assess its safety and tolerability. The study examined the drug's behavior in the body, including interactions with food or other medications. OD-07656 was well-tolerated, with most participants experiencing no serious side effects.

Although researchers are still studying this drug for ulcerative colitis, its prior testing in humans and general tolerability indicate a positive safety profile. Now in a Phase 2 trial, researchers have gathered enough safety information from earlier studies to test it on individuals with ulcerative colitis. This suggests the treatment is safe enough to proceed, but the study will continue monitoring for any unexpected health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about OD-07656 for ulcerative colitis because it offers a potentially novel approach. Unlike standard treatments, which often involve anti-inflammatory drugs like corticosteroids and TNF inhibitors, OD-07656 is an oral medication being tested in different dosing regimens. This could provide an easier and potentially more effective treatment option. If successful, this treatment might offer new hope for patients who have not responded well to existing therapies.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research has shown that OD-07656 is under study for its potential to help individuals with moderately to severely active ulcerative colitis (UC). Early results suggest it might reduce colon inflammation, a major issue in UC. In this trial, participants will receive different dosing regimens of OD-07656. Another treatment, vedolizumab, demonstrated significant improvement in internal camera exams, with a 28% improvement at 6 months and 61% at 12 months in other studies. While detailed results for OD-07656 alone are still being gathered, its development aims to improve symptoms and overall colon health in UC patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

Odyssey Therapeutics

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis who haven't had enough improvement with standard treatments like aminosalicylates, corticosteroids, immunosuppressants, or certain biologics and drugs targeting immune signaling pathways.

Inclusion Criteria

I have been diagnosed with ulcerative colitis.

My ulcerative colitis is moderate to severe, according to the Modified Mayo score.

I haven't responded well or can't tolerate certain Crohn's/colitis treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment with OD-07656

Participants receive OD-07656, an oral medication, twice daily

12 weeks

Treatment with Vedolizumab

Participants receive vedolizumab treatment following OD-07656

38 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OD-07656
• Vedolizumab

Trial Overview

The study tests OD-07656's effectiveness and safety in treating ulcerative colitis. It also looks at how well OD-07656 can improve the effects of another drug called Vedolizumab when used afterwards.

How Is the Trial Designed?

Group I: OD-07656 Dosing Regimen 3 Experimental Treatment 2 Interventions

Randomized, Oral, twice daily dose

Group II: OD-07656 Dosing Regimen 2 Experimental Treatment 2 Interventions

Randomized, Oral, twice daily dose

Group III: OD-07656 Dosing Regimen 1 Experimental Treatment 2 Interventions

Open Label, Oral, twice daily dose

Who Is Running the Clinical Trial?

Odyssey Therapeutics

Lead Sponsor

Trials

2

Recruited

160+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06850727

Study Details | NCT06850727 | Safety and Efficacy of OD- ...

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) ...

2.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/579279

Safety and Efficacy of OD-07656 and of Subsequent ...

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 ...

3.

trialx.com

trialx.com/clinical-trials/listings/300140/safety-and-efficacy-of-od-07656-and-of-subsequent-vedolizumab-therapy-in-moderately-to-severely-active-ulcerative-colitis/

Clinical Research Trial Listing ( UC - Ulcerative Colitis

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6445254/

Vedolizumab for Ulcerative Colitis: Treatment Outcomes from ...

Among patients with confirmed endoscopically active disease at baseline, cumulative rates of endoscopic improvement were 28% and 61% at 6 and 12 months ...

5.

miracleml.com

miracleml.com/blog/partnering-with-odyssey-therapeutics-to-transform-ulcerative-colitis-treatment

Partnering with Odyssey Therapeutics to Transform Ulcerative ...

Odyssey's UC study is designed in two parts to address two questions: first, induction efficacy of monotherapy OD-07656, and second, can OD- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06206811

Phase 1 Study to Investigate OD-07656 in Healthy Adult ...

First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, ...