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Phase III: Afimkibart in CD (SIBERITE-2)

Clinical Trial Overview

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With afimkibart (R07790121) in Patients With Moderately to Severely Active Crohn's Disease

Objective

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with afimkibart (R07790121) in participants with moderately to severely active Crohn's disease (CD).

Primary Endpoints

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Percentage of Participants with Endoscopic Response

Secondary Endpoints

Percentage of Participants with Symptomatic Remission
Percentage of Participants with Endoscopic Remission
Percentage of Participants with Ulcer-free Endoscopy
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Average of Daily Abdominal Pain Scores in the Past Week (APS)
Bowel Urgency
Fatigue
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of Participants with Clinical Response
Percentage of Participants with Symptomatic Response
Overall Change in CD Symptoms
Overall Severity in CD Symptoms
Change in General Well-being
Incidence and Severity of Adverse Events (AEs)
Presence of Draining Fistulas

AE=adverse events; APS=average daily abdominal pain scores in the past week; CDAI=Crohn’s Disease Activity Index; IBDQ=Inflammatory Bowel Disease Questionnaire; SF=stool frequency subscore

Afimkibart

Other names: RG6631, R07790121
Modality: Anti-TL1A monoclonal antibody

QUICK LINKS

Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

Confirmed diagnosis of CD
Moderately to severely active CD
Bodyweight >= 40 kilogram (kg)
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
Diagnosis of short gut or short bowel syndrome
Presence of an ileostomy, colostomy or ileoanal pouch
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Presence of abdominal or perianal abscess
Presence of rectovaginal fistulas or perianal fistulas with >3 openings
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

CMV=cytomegalovirus; HBV=Hepatitis B; HCV=Hepatitis C; HIV=human immunodeficiency virus; kg=Kilogram; B=tuberculosis; TL1A=Tumor Necrosis Factor-like Ligand 1A; UC=ulcerative colitis;

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT06819891

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of April 21, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT