RO7790121 for Crohn's Disease

(SIBERITE-1 Trial)

Recruiting at 344 trial locations

Overseen By Reference Study ID Number: GA45331 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: Ulcerative colitis, Short bowel, Pregnancy, Infections, 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

600 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 Crohn's disease, which causes inflammation in the digestive tract. The study aims to determine the effectiveness and safety of Afimkibart for individuals with moderately to severely active Crohn's disease who haven't found success with other treatments. Participants will receive either Afimkibart or a placebo (a harmless, inactive substance) to compare results. Suitable candidates have Crohn's disease that hasn't responded well to other therapies and are experiencing significant symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop 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 this treatment is likely to be safe for humans?

Research shows that afimkibart (RO7790121) is being tested for safety in people with Crohn's disease. Earlier studies on afimkibart, which targets a protein linked to inflammation, found it to be generally well-tolerated. Some participants experienced mild side effects, such as headaches and injection site reactions. The current studies aim to gather more detailed safety information, but existing evidence suggests that afimkibart is safe enough for further testing in larger patient groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Unlike the standard treatments for Crohn's Disease, which often include medications like corticosteroids, immunosuppressants, and TNF inhibitors, afimkibart offers a novel approach. Researchers are excited about afimkibart because it introduces a unique mechanism of action, potentially targeting pathways not addressed by current therapies. Additionally, it offers a new delivery method, combining intravenous (IV) and subcutaneous (SC) administration, which might enhance its effectiveness and patient convenience. This fresh approach could bring new hope to those who haven't responded well to existing treatments.

What evidence suggests that RO7790121 might be an effective treatment for Crohn's disease?

Research shows that afimkibart, a type of medication, may help treat moderate to severe Crohn's disease. Earlier studies found that afimkibart had a good balance of benefits and risks. Some patients noticed significant improvements in their symptoms. Specifically, about 48% of patients in one study reported positive effects during the initial treatment phase, and 59% experienced benefits during ongoing treatment. In this trial, participants will receive afimkibart in one of the experimental arms. These findings suggest that afimkibart could be a useful option for managing Crohn's disease symptoms. ^{1 2 3 4 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 adults with a confirmed diagnosis of moderately to severely active Crohn's Disease who weigh at least 40 kg. They must have tried other treatments without success or couldn't tolerate them. Participants need to follow specific contraception guidelines if they can have children.

Inclusion Criteria

My Crohn's disease is moderate to severe.

I have been diagnosed with Crohn's disease.

I weigh at least 40 kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive induction therapy with RO7790121 intravenously

12 weeks

Multiple visits (in-person)

Maintenance Therapy

Participants continue with maintenance therapy using RO7790121 subcutaneous injections

40 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7790121

Trial Overview

The study is testing RO7790121, a potential new treatment for Crohn's Disease. It compares the effects of this drug against a placebo during two phases: induction and maintenance therapy, in a controlled environment where neither the participants nor the researchers know who receives which treatment.

How Is the Trial Designed?

Group I: Arm 2: Afimkibart Experimental Treatment 1 Intervention

Participants will receive afimkibart IV followed by afimkibart SC injection.

Group II: Arm 1: Afimkibart Experimental Treatment 1 Intervention

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

Group III: Arm 3: 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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06819878

NCT06819878 | A Study to Assess the Efficacy and Safety ...

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active ...

2.

pubmed.ncbi.nlm.nih.gov

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

Anti-TL1A antibody, afimkibart, in moderately-to-severely ...

However, secondary endpoints suggest that afimkibart was associated with a favourable benefit-risk profile, with clinically meaningful ...

3.

genentech-clinicaltrials.com

genentech-clinicaltrials.com/en/trials/autoimmune-disorder/crohn-s-disease/a-study-to-assess-the-efficacy-and-safety-of-induction--94939.html

Clinical Study | Crohn's Disease RO7790121 | ForPatients-...

A study to assess the effectiveness and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease.

4.

forpatients.roche.com

forpatients.roche.com/content/patient-platform/global/en/trials/autoimmune-disorder/crohn-s-disease/a-study-to-assess-the-efficacy-and-safety-of-induction--32899.pdf

A study to test the effectiveness and safety of RO7790121 for ...

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy ...

5.

thelancet.com

thelancet.com/journals/langas/article/PIIS2468-1253(25)00129-3/abstract

Anti-TL1A antibody, afimkibart, in moderately-to-severely ...

Overall, 117 (48%) of 245 patients in the induction phase and 132 (59%) of 224 patients in the maintenance phase reported at least one treatment ...

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20588363

Clinical Trials

A Study To Assess The Efficacy And Safety Of Induction And Maintenance Therapy With Afimkibart (RO7790121) In Participants With Moderately To ...