A Study to Assess the Efficacy and Safety of Afimkibart for Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07846683 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CA46523
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Moderately to Severely Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Remission

  At Week 12

Secondary Outcomes (17)

• Change From Baseline in Stool Frequency Subscore (SFS)

  From Baseline up to Week 12

• Change From Baseline in Rectal Bleeding Subscore (RBS)

  From Baseline up to Week 12

• Percentage of Participants With Symptomatic Response

  At Week 4

• Percentage of Participants With Endoscopic Improvement

  At Week 12 and Week 24

• Percentage of Participants With Endoscopic Remission

  At Week 12 and Week 24

Study Arms (2)

Afimkibart

EXPERIMENTAL

Participants will receive afimkibart administered as subcutaneous (SC) injection.

Drug: Afimkibart

Placebo

PLACEBO COMPARATOR

Participants will receive placebo adminsitered as SC injection.

Drug: Placebo

Interventions

Afimkibart DRUG

Afimkibart will be administered as SC injection.

Also known as: PF-06480605, RVT-3101, RO7790121

Afimkibart

Placebo DRUG

Placebo will be administered as SC injection.

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of UC.
• Moderately to severely active UC assessed by modified Mayo Score (mMS).
• Bodyweight \>= 40 kilogram (kg).
• Up to date with colorectal cancer (CRC) screening performed according to local standards.
• Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy.
• Females of childbearing potential must meet protocol criteria for contraception requirements.

You may not qualify if:

• Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).
• Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.
• Presence of an ostomy or ileoanal pouch.
• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Chugai Pharmaceutical: collaborator
• Pfizer: collaborator

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share