RO7790121 for Ulcerative Colitis

(Ametrine-1 Trial)

Recruiting at 321 trial locations

Overseen By Reference Study ID Number: GA45329 https://forpatients.roche.com/

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-TL1A therapy

Disqualifiers: Crohn's disease, Pregnancy, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Afimkibart (also known as RO7790121) for people with ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. The researchers aim to determine if Afimkibart reduces symptoms more effectively than a placebo, which contains no active medicine. Participants will have moderately to severely active UC and will have tried other UC treatments without success. The trial includes two groups: one receiving Afimkibart and the other a placebo, both administered through IV and then injection. For those with long-standing UC who have not responded well to other treatments, this trial might be suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering early access to a potentially effective 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. However, it mentions that certain medicines are prohibited, including anti-TL1A therapy, so you may need to discuss your current medications with the trial team.

Is there any evidence suggesting that RO7790121 is likely to be safe for humans?

Research has shown that Afimkibart (RO7790121), a treatment being tested for ulcerative colitis, has generally been well-tolerated. In one study, participants taking different doses of Afimkibart reported side effects such as ulcerative colitis symptoms, low red blood cell count (anemia), tiredness, headache, and fever. However, these side effects were not severe for most participants. Another report found that Afimkibart was safe for 245 adults with moderate to severe ulcerative colitis, indicating that most did not experience serious problems from the treatment. Overall, these findings suggest that Afimkibart is relatively safe for humans based on past research. ^{1 2 3 4 5}

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

Researchers are excited about afimkibart for ulcerative colitis because it offers a new approach compared to standard treatments like aminosalicylates, corticosteroids, and biologics. Unlike these existing options, afimkibart is administered both intravenously and subcutaneously, potentially offering more flexible dosing. Moreover, afimkibart operates through a novel mechanism of action, which might provide relief for patients not responding to current therapies. This fresh approach could lead to better management of symptoms and improved quality of life for those with ulcerative colitis.

What evidence suggests that RO7790121 might be an effective treatment for ulcerative colitis?

This trial will compare afimkibart with a placebo for treating moderate to severe ulcerative colitis (UC). Research has shown that afimkibart, a type of antibody, may help treat UC. Previous studies found that afimkibart can reduce symptoms in patients. In one study, different doses were tested, and afimkibart effectively managed UC symptoms. Patients experienced improvement in their condition with afimkibart treatment. These findings suggest that afimkibart could be a helpful option for people with UC seeking new treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with moderately to severely active ulcerative colitis, which is a type of inflammatory bowel disease causing ulcers and long-lasting inflammation in the digestive tract.

Inclusion Criteria

I have been diagnosed with ulcerative colitis.

My ulcerative colitis is moderate to severe.

My weight is at least 40 kg.

Exclusion Criteria

Presence of an ostomy or ileoanal pouch

Pregnancy or breastfeeding, or intention of becoming pregnant during the study

I have active TB or untreated/under-treated latent TB.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive RO7790121 or placebo intravenously for induction of remission

12 weeks

Maintenance Treatment

Participants continue with RO7790121 or placebo subcutaneous injections to maintain remission

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7790121

Trial Overview The study tests RO7790121 against a placebo to see if it's more effective and safe as an induction and maintenance therapy for ulcerative colitis. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Afimkibart Experimental Treatment 1 Intervention

Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo IV followed by placebo SC.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Chugai Pharmaceutical

Industry Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40706613/

Anti-TL1A antibody, afimkibart, in moderately-to-severely ... We evaluated the safety and efficacy of multiple doses of afimkibart, a TL1A-directed antibody, in patients with moderately-to-severely active ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06589986

NCT06589986 | A Study to Assess the Efficacy and Safety ... This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(25)00174-X/abstract

RESULTS FROM THE PHASE 2B TUSCANY-2 TRIAL We report results from TUSCANY-2, a phase 2b, randomized, double-blind, treat-through, dose-ranging study evaluating efficacy and safety of subcutaneous (SC) ...

4. investor.roivant.com investor.roivant.com/news-releases/news-release-details/roivant-reports-chronic-period-data-rvt-3101-tuscany-2-phase-2b

Roivant Reports Chronic Period Data for RVT-3101 from the ... Roivant Sciences (Nasdaq: ROIV) today announced positive results from the chronic period of the TUSCANY-2 Phase 2b study of RVT-3101, a once-monthly ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125325001293

Anti-TL1A antibody, afimkibart, in moderately-to-severely ... Here, we report results from the phase 2b TUSCANY-2 trial that evaluated the safety and efficacy of 50 mg, 150 mg, and 450 mg doses of afimkibart in adults with ...

6. investor.roivant.com investor.roivant.com/news-releases/news-release-details/roivant-announces-statistically-significant-and-clinically

Press Release - Investor Relations | Roivant Sciences Ltd. RVT-3101 was well tolerated and showed a favorable safety ... RVT-3101 in 245 adult participants with moderate to severe ulcerative colitis.