VTX002 for Ulcerative Colitis

Recruiting at 120 trial locations

Overseen By Chohee Yun, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oppilan Pharma Ltd

Disqualifiers: Severe colitis, Crohn's, others

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

Compensation: Varies

Number of Visits: 3

213 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tablet, VTX002, to determine its effectiveness for people with moderate to severe ulcerative colitis (UC), a condition that inflames the colon, causing stomach pain and frequent diarrhea. Participants will take one of two doses of VTX002 or a placebo (a pill with no active medicine) daily to assess its safety and effectiveness. The trial is for individuals who have had UC for at least three months and have active disease confirmed by a doctor's exam. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in UC treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that VTX002 is safe and well-tolerated for people with ulcerative colitis. In one study, researchers tested VTX002 in two different doses, both of which proved safe. Participants experienced no major problems, though there was a decrease in lymphocytes, a type of white blood cell. This side effect was not serious. Overall, current data suggests that VTX002 is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which often involve corticosteroids, immunosuppressants, or biologics, VTX002 offers a novel approach. Researchers are excited because VTX002 targets the S1P1 receptor, which plays a crucial role in managing immune cell movement and inflammation. This mechanism is different from current options, potentially offering a more targeted way to reduce inflammation with fewer side effects. VTX002 is administered orally, providing a convenient alternative to injectable therapies. By focusing on this unique pathway, VTX002 may offer new hope for patients looking for effective and easier-to-use treatments.

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

Research has shown that VTX002, also known as Tamuzimod, holds promise for treating ulcerative colitis (UC). In one study, 28% of patients experienced a symptom-free period with a 60mg dose of VTX002, while another dose led to remission in 24% of patients. This trial will test different doses of VTX002, labeled as Dose A and Dose B, to evaluate their effectiveness in managing symptoms for people with moderate to severe UC. The treatment caused few side effects, indicating it was well tolerated. This makes VTX002 a hopeful option for those seeking new UC treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Snehal Naik, PhD

Principal Investigator

Ventyx Biosciences, Inc

Are You a Good Fit for This Trial?

This trial is for people who've had moderate to severe ulcerative colitis (UC) for at least 3 months. They must have active UC confirmed by a special camera test called endoscopy. People with other types of colitis, severe widespread colitis, Crohn's disease, or a history of certain abnormal connections in their intestines can't join.

Inclusion Criteria

Active UC confirmed by endoscopy

I was diagnosed with ulcerative colitis more than 3 months ago.

Exclusion Criteria

I have severe widespread inflammation in my colon.

I have been diagnosed with a specific type of colitis.

I have been diagnosed with Crohn's disease or have a history of fistulas related to it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Induction Treatment

Participants receive VTX002 Dose A, Dose B, or placebo for 13 weeks, including 7 days of titration followed by 12 weeks of treatment at the assigned dose

13 weeks

Visits at Weeks 1, 4, 8, and 13

Long-Term Extension (LTE) Treatment

Participants continue treatment with VTX002 for up to 39 weeks

39 weeks

Open-Label Extension (OLE) Treatment

Participants may opt into continuation of treatment with VTX002 for up to 143 weeks

143 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VTX002

Trial Overview The study tests if VTX002 tablets are safe and effective when taken daily by UC patients compared to a placebo (a pill without any medicine). Participants will be randomly assigned to receive either VTX002 at two different doses or placebo and followed up for up to 36 months including various treatment phases.

How Is the Trial Designed?

Group I: VTX002 Dose B Experimental Treatment 1 Intervention

VTX002 Dose B tablet administered orally once daily

Group II: VTX002 Dose A Experimental Treatment 1 Intervention

VTX002 Dose A tablet administered orally once daily

Group III: Placebo Placebo Group 1 Intervention

Placebo tablet administered orally once daily

Who Is Running the Clinical Trial?

Oppilan Pharma Ltd

Lead Sponsor

Trials

2

Recruited

230+

Citations

1. ir.ventyxbio.com ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-presents-new-52-week-results-phase-2-trial

Release Details Ventyx Biosciences Presents New 52-Week Results from the Phase 2 Trial of VTX002 (Tamuzimod) in Ulcerative Colitis at UEG Week 2024. October ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39793589/

Tamuzimod in patients with moderately-to-severely active ... Induction therapy with tamuzimod was effective and well tolerated in patients with ulcerative colitis. These results and the favourable risk-benefit profile of ...

3. ir.ventyxbio.com ir.ventyxbio.com/static-files/c5704463-dc0e-42dd-80b6-fc2bf2218cbb

VTX002 Phase 2 Ulcerative Colitis Results VTX002 Phase 2 Ulcerative Colitis Results. Raju Mohan, PhD ... ➢ Phase 2 data support further development of VTX002 in ulcerative colitis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05156125

Study Details | NCT05156125 | VTX002 Versus Placebo for ... This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/ventyx-biosciences-uc-trial/

Ventyx Biosciences reports data from ulcerative colitis ... The primary endpoint of clinical remission was achieved in 28% of patients who received the 60mg dosage of VTX002 and 24% of patients given the ...

6. ir.ventyxbio.com ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-present-results-phase-2-trial-vtx002

Ventyx Biosciences to Present Results of the Phase 2 Trial ... Results of the Phase 2 trial of VTX002 (S1P1R modulator) in ulcerative colitis to be highlighted in oral presentation on February 22nd.