Moderately to Severely Active Ulcerative ColitisPhase 3AMETRINE-SCNCT07846683
A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart 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 at 1 site in United States.
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
- Conditions the study is for
- Moderately to Severely Active Ulcerative Colitis
- 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
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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.
Show all 10Show fewer
- 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
1 site in 1 country. 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
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United States1 site, 1 recruiting
- Recruiting
Gastro One
Cordova, Tennessee, 38018
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 group | Role | What they receive |
|---|---|---|
| Afimkibart | Experimental | Participants will receive afimkibart administered as subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Placebo | Placebo comparator | Participants 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.
Percentage of Participants With Clinical Remission
Measured: At Week 12
Secondary outcomes (17)
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
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
Percentage of Participants With Symptomatic Response
Measured: At Week 4
Percentage of Participants With Endoscopic Improvement
Measured: At Week 12 and Week 24
Percentage of Participants With Endoscopic Remission
Measured: At Week 12 and Week 24
Percentage of Participants With Clinical Response
Measured: At Week 12
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Measured: At Week 12 and Week 24
Percentage of Participants With Clinical Remission
Measured: At Week 24
Percentage of Participants With Maintenance of Remission
Measured: At Week 12 and Week 24
Percentage of Participants With Histologic Improvement
Measured: At Week 24
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
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
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
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
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
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
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.
- First posted29 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical, Pfizer
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846683
- Sponsor's protocol ID
- CA46523
- Other IDs
- 2026-526684-37-00
- Acronym
- AMETRINE-SC
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 26 Oct 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07846683
- Acronym / sponsor ID
- AMETRINE-SC / CA46523
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical, Pfizer
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afimkibart | Experimental | Drug: AfimkibartParticipants will receive afimkibart administered as subcutaneous (SC) injection. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo adminsitered as SC injection. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfimkibartAlso: PF-06480605, RVT-3101, RO7790121Afimkibart will be administered as SC injection. | Drug | Afimkibart |
| PlaceboPlacebo will be administered as SC injection. | Drug | Placebo |
Primary outcome
Percentage of Participants With Clinical Remission
Time frame: At Week 12
17 secondary outcomes
Change From Baseline in Stool Frequency Subscore (SFS)
Time frame: From Baseline up to Week 12
Change From Baseline in Rectal Bleeding Subscore (RBS)
Time frame: From Baseline up to Week 12
Percentage of Participants With Symptomatic Response
Time frame: At Week 4
Percentage of Participants With Endoscopic Improvement
Time frame: At Week 12 and Week 24
Percentage of Participants With Endoscopic Remission
Time frame: At Week 12 and Week 24
Percentage of Participants With Clinical Response
Time frame: At Week 12
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Time frame: At Week 12 and Week 24
Percentage of Participants With Clinical Remission
Time frame: At Week 24
Percentage of Participants With Maintenance of Remission
Time frame: At Week 12 and Week 24
Percentage of Participants With Histologic Improvement
Time frame: At Week 24
Change From Baseline in Bowel Urgency
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Abdominal Pain
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Fatigue
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Health-Related Quality of Life
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Overall UC Symptoms
Time frame: Baseline, Week 2, Week 12 and Week 24
Change From Baseline in Overall Severity in UC Symptoms
Time frame: Baseline, Week 2, Week 12 and Week 24
Incidence and Severity of Adverse Events (AEs)
Time frame: From Baseline up to approximately 42 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Moderately to Severely Active Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Moderately to Severely Active Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 3
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Ulcerative Colitis, Obesity or Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Remission (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.