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Moderately to Severely Active Ulcerative ColitisPhase 3AMETRINE-SCNCT07846683

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

A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 16 to 80 years
What is being tested?
Afimkibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
No sites listed yet
Study dates
15 Nov 2026to 31 Dec 2030
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

Official title: A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis

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).

Being tested
Afimkibart, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfimkibartDrug

    Also called PF-06480605, RVT-3101, RO7790121

    Afimkibart will be administered as SC injection.

  • PlaceboDrug

    Placebo will be administered as SC injection.

Study groups in NCT07846683
Study groupRoleWhat they receive
AfimkibartExperimentalParticipants will receive afimkibart administered as subcutaneous (SC) injection.
Receives: Drug: Afimkibart
PlaceboPlacebo comparatorParticipants will receive placebo adminsitered as SC injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Clinical Remission

    Measured: At Week 12

Secondary outcomes (17)

  1. Change From Baseline in Stool Frequency Subscore (SFS)

    The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal)

    Measured: From Baseline up to Week 12

  2. Change From Baseline in Rectal Bleeding Subscore (RBS)

    The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed)

    Measured: From Baseline up to Week 12

  3. Percentage of Participants With Symptomatic Response

    Measured: At Week 4

  4. Percentage of Participants With Endoscopic Improvement

    Measured: At Week 12 and Week 24

  5. Percentage of Participants With Endoscopic Remission

    Measured: At Week 12 and Week 24

  6. Percentage of Participants With Clinical Response

    Measured: At Week 12

  7. Percentage of Participants With Histologic-Endoscopic Mucosal Improvement

    Measured: At Week 12 and Week 24

  8. Percentage of Participants With Clinical Remission

    Measured: At Week 24

  9. Percentage of Participants With Maintenance of Remission

    Measured: At Week 12 and Week 24

  10. Percentage of Participants With Histologic Improvement

    Measured: At Week 24

  11. Change From Baseline in Bowel Urgency

    Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes/No) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency)

    Measured: From Baseline through Week 12 and Week 24

  12. Change From Baseline in Abdominal Pain

    Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes/No) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain)

    Measured: From Baseline through Week 12 and Week 24

  13. Change From Baseline in Fatigue

    Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue

    Measured: From Baseline through Week 12 and Week 24

  14. Change From Baseline in Health-Related Quality of Life

    Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life

    Measured: From Baseline through Week 12 and Week 24

  15. Change From Baseline in Overall UC Symptoms

    Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse"

    Measured: Baseline, Week 2, Week 12 and Week 24

  16. Change From Baseline in Overall Severity in UC Symptoms

    Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe"

    Measured: Baseline, Week 2, Week 12 and Week 24

  17. Incidence and Severity of Adverse Events (AEs)

    Measured: From Baseline up to approximately 42 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846683
Sponsor's protocol ID
CA46523
Acronym
AMETRINE-SC
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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