Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis

No longer recruiting at 177 trial locations

Overseen By Reference Study ID Number: GA44839 https://forpatients.roche.com/

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must not be taking: JAK inhibitors

Disqualifiers: Crohn's disease, Colectomy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called vixarelimab for individuals with moderate to severe ulcerative colitis (UC) who haven't responded to other treatments. Researchers aim to evaluate the effectiveness, safety, and processing of vixarelimab compared to a placebo (a harmless, inactive substance). Participants will receive either vixarelimab or a placebo during the trial. This trial may suit those who have had UC for at least three months and find other treatments ineffective or difficult to tolerate. As a Phase 2 trial, this research measures vixarelimab's effectiveness in an initial, smaller group, offering a chance to explore a promising new treatment option.

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 vixarelimab is likely to be safe for humans?

Research has shown that vixarelimab has been tested for safety in humans. Other studies tested it in people with prurigo nodularis, a skin condition, and found it generally well-tolerated. Most patients experienced few side effects, such as mild headaches or minor skin reactions at the injection site.

Vixarelimab is currently in a Phase 2 trial for ulcerative colitis, providing some early safety information, though more data is needed. Phase 2 trials typically involve more participants to assess how well the treatment is tolerated.

Overall, while early results appear promising, ongoing studies will provide a clearer understanding of its safety for people with ulcerative colitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about vixarelimab for ulcerative colitis because it offers a novel approach to treatment by targeting the OSM (oncostatin M) pathway, a different mechanism than standard therapies like aminosalicylates, corticosteroids, and biologics that mostly target inflammation in other ways. Vixarelimab is administered subcutaneously, potentially offering a more convenient and less invasive option compared to some existing intravenous treatments. Additionally, it may provide an alternative for patients who do not respond well to current therapies, highlighting its potential as a game-changer in the management of ulcerative colitis.

What evidence suggests that vixarelimab might be an effective treatment for ulcerative colitis?

Research has shown that vixarelimab might help treat ulcerative colitis, particularly for patients who haven't responded to other treatments. It targets specific proteins that cause inflammation, potentially reducing symptoms. Early findings suggest vixarelimab could be especially beneficial for those unresponsive to TNF inhibitors, a common medication for ulcerative colitis. In this trial, participants will receive either Vixarelimab Dose Regimen 1, Vixarelimab Dose Regimen 2, or a placebo. Although more research is needed, these early results offer promise for people with moderate to severe cases of the condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trial

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for people who have been living with ulcerative colitis (UC) for at least three months. It's specifically aimed at those whose UC is moderate to severe and haven't had success with, or can't tolerate, standard or advanced treatments.

Inclusion Criteria

inadecuate /los of response to advance or conventional treatment

My ulcerative colitis is moderate to severe.

I have been diagnosed with ulcerative colitis for at least 3 months.

Exclusion Criteria

Have you been diagnosed with Crohn's Disease?

Extensive colonic resection, presence of ileostomy or colostomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive vixarelimab or placebo to test the induction of clinical remission

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Active Treatment Extension (optional)

Participants receive vixarelimab to explore durability of clinical response and remission

Up to 44 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vixarelimab

Trial Overview The study tests Vixarelimab against a placebo in participants with moderate to severe UC. The goal is to see if Vixarelimab is effective, safe, and how the body processes it compared to a non-active treatment.

How Is the Trial Designed?

Group I: Vixarelimab Dose Regimen 2 Experimental Treatment 1 Intervention

Participants will receive vixarelimab SC during the induction period and the optional ATE period.

Group II: Vixarelimab Dose Regimen 1 Experimental Treatment 1 Intervention

Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.

Group III: Placebo Placebo Group 2 Interventions

Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06137183

NCT06137183 | A Study to Evaluate the Efficacy, Safety, ... The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1743/7968127

P0929 Design and rationale for the phase 1c study evaluating ... An ongoing randomized, placebo-controlled Phase 2 MOONGLOW study (NCT06137183) is evaluating the efficacy and safety of vixarelimab in patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06693908

NCT06693908 | A Study to Evaluate the Activity, and Safety ... This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).

4. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/ibd/a-study-to-evaluate-the-efficacy--safety--and-pharmacok-50752.html

Clinical trial for Ulcerative Colitis-Genentech A Member ... The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate ...

5. sigma.larvol.com sigma.larvol.com/product.php?e1=778943&tab=newstrac

vixarelimab (RG6536) News Together, these data suggest that vixarelimab may represent an approach for treating TNF-refractory ulcerative colitis patients with high levels of circulating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9932343/

Efficacy and safety of vixarelimab, a human monoclonal ... This is the first published study in patients with prurigo nodularis investigating the clinical efficacy and safety of a monoclonal antibody targeting both IL- ...

7. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/ibd/a-study-to-evaluate-the-activity--and-safety-of-vixarel-16448.html

Clinical trial for Ulcerative Colitis-Genentech A Member ... This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).