Moderately to Severely Active Ulcerative Colitis
Phase 3 Study of Afimkibart for Moderately to Severely Active Ulcerative Colitis
This study is investigating the effectiveness and safety of afimkibart induction therapy compared with placebo in people aged 16–80 who have moderately to severely active ulcerative colitis.
Registry title: A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
70 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- Afimkibart or Placebo
- Design
- Randomized · Double
- Central study contact
- Reference Study ID Number: GA45330 https://forpatients.roche.com/ No attachments to email below.888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
- Sponsor
- Hoffmann-La Roche
Research question
Compared with placebo, how effective and safe is afimkibart as induction therapy for moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for people with a confirmed diagnosis of moderately to severely active ulcerative colitis.
- The registry age range is 16 through 80 years.
- Participants must weigh at least 40 kilograms.
- The study is looking for people whose ulcerative colitis did not respond adequately, stopped responding, or was not tolerated with at least one protocol-specified conventional or advanced therapy.
Participation overview
What participation may involve
Participants receive either afimkibart or matching placebo, first intravenously and then by subcutaneous injection. The study assesses ulcerative colitis activity, symptoms, quality of life, tissue findings, and adverse events. What participation may involve: - Receive an intravenous infusion followed by a subcutaneous injection of either afimkibart or matching placebo. - Have ulcerative colitis disease activity assessed using stool frequency, rectal bleeding, and endoscopic findings. - Complete assessments about bowel urgency, abdominal pain, fatigue, quality of life, and overall symptom change and severity. - Be monitored for adverse events, including serious events and events that lead to stopping study treatment.
Study interventions
What participants may receive or do
- Afimkibart: Participants assigned to this group receive afimkibart first through an intravenous infusion and then by a subcutaneous injection.
- Placebo: Participants assigned to this group receive placebo matching intravenous afimkibart followed by placebo matching subcutaneous afimkibart.
Study design
How the comparison works
This is a Phase 3, randomized, parallel-group study comparing afimkibart with placebo. Participants and investigators are masked to treatment assignment. Participants are assigned at random to parallel afimkibart or placebo groups; the registry does not report the assignment ratio. The study is double-masked: both participants and investigators are masked to treatment assignment. The control group receives placebo matching both the intravenous and subcutaneous forms of afimkibart. A placebo group is included, but the registry does not state each participant's probability of receiving placebo.
Reported activities
Procedures and tests
- Intravenous infusion of afimkibart or matching placebo.
- Subcutaneous injection of afimkibart or matching placebo.
- Endoscopic assessment of the colon is used to measure disease activity and improvement.
- Colon tissue is assessed using the Geboes histologic grading system.
- Stool frequency and rectal bleeding are recorded as measures of ulcerative colitis activity.
- Participants complete patient-reported assessments of bowel urgency and abdominal pain.
- Participants complete the 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- Participants complete the 32-item Inflammatory Bowel Disease Questionnaire about health-related quality of life.
- The study monitors the incidence and severity of adverse events.
- Screening may involve confirming that colorectal cancer screening is current according to local standards.
- Screening may involve confirming the absence of specified infections, including Clostridioides difficile, cytomegalovirus, HIV, hepatitis B, hepatitis C, and disqualifying tuberculosis.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A confirmed diagnosis of ulcerative colitis is required.
- Ulcerative colitis must be moderately to severely active based on the modified Mayo Score.
- Participants must weigh at least 40 kilograms.
- Colorectal cancer screening must be current according to local standards.
- At least one protocol-specified conventional or advanced ulcerative colitis therapy must have produced an inadequate response, a loss of response, or intolerance.
- Males and females of childbearing potential must follow the protocol's contraception requirements.
Possible reasons someone may not be able to join
- Known current complications such as fulminant colitis or toxic megacolon are exclusionary.
- A current diagnosis of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis is exclusionary.
- People with an ostomy or ileoanal pouch are excluded.
- A current diagnosis or suspicion of primary sclerosing cholangitis is exclusionary.
- Pregnancy, breastfeeding, or intending to become pregnant during the study is exclusionary.
- Definite low-grade or high-grade colonic dysplasia, or adenomas or neoplasia that were not completely removed, is exclusionary.
- A malignancy within the past five years is exclusionary, except specified adequately resected non-metastatic skin cancers or in situ cervical cancer.
- Evidence of Clostridioides difficile, cytomegalovirus, HIV, hepatitis B, or hepatitis C infection is exclusionary.
- Active tuberculosis, latent tuberculosis not successfully treated according to local guidance, or inadequately treated tuberculosis is exclusionary.
- Receiving protocol-specified prohibited medicines, including any known exposure to anti-TL1A therapy, is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not provide the number, frequency, or format of study visits.
- Outcomes are assessed at Weeks 2 and 12, and adverse events are monitored up to 30 weeks after baseline, but total individual participation duration is not explicitly stated.
- The registry states that assignment is randomized but does not provide the allocation ratio or chance of receiving placebo.
- The registry does not state which current ulcerative colitis treatments may continue during the study.
- The registry mentions protocol-specified prohibited medicines but does not identify them or provide washout periods.
- The registry does not describe rescue treatment if ulcerative colitis worsens.
- Endoscopic outcomes are reported at Week 12, but the registry does not give the complete endoscopy schedule or preparation requirements.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether travel, lodging, parking, or meals are reimbursed.
- The registry does not describe access to afimkibart after study treatment ends.
- The study is recruiting overall, but listed locations have different statuses, so availability must be confirmed with a specific site.
Before contacting the site
Questions for the study team
- What is the assignment ratio, and what is my chance of receiving placebo?
- What are the complete visit schedule and total participation duration, including screening and follow-up?
- Which ulcerative colitis medicines can continue, which must stop, and what washout periods apply?
- How many endoscopies and tissue collections are required, and what preparation and sedation are involved?
- What happens if my ulcerative colitis worsens during the study, and what rescue treatment is allowed?
- Which study-related costs are covered, and are compensation or travel assistance available?
- Is the site nearest me currently recruiting, and are any study activities available remotely?
- Is afimkibart available after study treatment ends, and under what conditions?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks could come from changing or pausing my current treatment for screening or study participation?
- Are there approved treatment alternatives that I should compare with this study before deciding whether to contact a site?
- Do my infection history, tuberculosis status, colorectal cancer screening, or liver and colon findings need review before I contact the study team?
- If I explore this study, how should you and the research team coordinate my usual care, symptom monitoring, and treatment if my disease worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Study design and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- GA45330
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Interventions: Drug: Afimkibart
Placebo Comparator
Placebo
Participants will receive placebo IV followed by placebo SC.
Interventions: Drug: Placebo
Interventions
Drug
Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Drug
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (6)
- Confirmed diagnosis of UCRegistry-derived · unreviewed
- Moderately to severely active UC assessed by mMSRegistry-derived · unreviewed
- Bodyweight \>= 40 kilogram (kg)Registry-derived · unreviewed
- Up to date with colorectal cancer (CRC) screening performed according to local standardsRegistry-derived · unreviewed
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapyRegistry-derived · unreviewed
- Males and females of childbearing potential must meet protocol criteria for contraception requirementsRegistry-derived · unreviewed
Exclusion criteria (10)
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)Registry-derived · unreviewed
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitisRegistry-derived · unreviewed
- Presence of an ostomy or ileoanal pouchRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-derived · unreviewed
- Pregnancy or breastfeeding, or intention of becoming pregnant during the studyRegistry-derived · unreviewed
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removedRegistry-derived · unreviewed
- 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 cancerRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TBRegistry-derived · unreviewed
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapyRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants with Clinical Remission
Time frame: At Week 12
Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
Secondary outcome
Change in Partial Modified Mayo Score (pmMS)
Time frame: From baseline to Week 2
Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed).
Secondary outcome
Percentage of Participants with Endoscopic Improvement
Time frame: At Week 12
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.
Secondary outcome
Percentage of Participants with Endoscopic Remission
Time frame: At Week 12
Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.
Secondary outcome
Percentage of Participants with Clinical Response
Time frame: At Week 12
Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS \>= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease).
Secondary outcome
Percentage of Participants with Histologic Improvement
Time frame: At Week 12
Percentage of participants achieving a histologic improvement, defined as Geboes \<=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
Secondary outcome
Percentage of Participants with Histologic Remission
Time frame: At Week 12
Percentage of participants achieving a histologic remission, defined as Geboes \<2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
Secondary outcome
Participants with Histologic-Endoscopic Mucosal Improvement
Time frame: At Week 12
Percentage of participants achieving Geboes \<= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
Secondary outcome
Percentage of Participants with Histologic-Endoscopic Remission
Time frame: At Week 12
Percentage of participants achieving Geboes \< 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).
Secondary outcome
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
Secondary outcome
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups.
Secondary outcome
Change in Bowel Urgency
Time frame: Baseline through Week 12
Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).
Secondary outcome
Change in Abdominal Pain
Time frame: Baseline through Week 12
Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).
Secondary outcome
Change in Fatigue
Time frame: Baseline to Week 12
Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. 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.
Secondary outcome
Change in Health-Related Quality of Life
Time frame: Baseline to Week 12
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. 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.
Secondary outcome
Overall Change in UC Symptoms
Time frame: Baseline to Week 2 and Week 12
Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse".
Secondary outcome
Overall Severity in UC Symptoms
Time frame: Baseline to Week 2 and Week 12
Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".
Secondary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to 30 Weeks after Baseline
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Recruiting locations in the United States
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
RecruitingDothan, Alabama, 36305, United States
Mayo Clinic Hospital
RecruitingScottsdale, Arizona, 85259, United States
Arizona Digestive Health, P.C (ADH)
RecruitingSun City, Arizona, 85351, United States
Om Research LLC
RecruitingApple Valley, California, 92307, United States
Valley View Internal Medicine
RecruitingGarden Grove, California, 92845, United States
Gastro Care Associates
RecruitingLancaster, California, 93534, United States
University of Southern California
RecruitingLos Angeles, California, 90033-1057, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
RecruitingNewport Beach, California, 92663, United States
Stanford Medicine Outpatient Center
RecruitingRedwood City, California, 94063, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Hi Tech and Global Research, LLC
RecruitingCoral Gables, Florida, 33134, United States
The Sister Life Research
RecruitingHialeah, Florida, 33013, United States
Allied Biomedical Research Institute
RecruitingMiami, Florida, 33155, United States
LCC Medical Research Institute, LLC
RecruitingMiami, Florida, 33126, United States
Digestive and Liver Center of Florida
RecruitingOrlando, Florida, 32825, United States
Integrity Trials LLC
RecruitingOrlando, Florida, 32807, United States
Advanced Medical Research Center
RecruitingPort Orange, Florida, 32127, United States
Guardian Angel Research Center, LLC
RecruitingTampa, Florida, 33614, United States
Santos Research Center, CORP
RecruitingTampa, Florida, 33615, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
RecruitingTampa, Florida, 33612, United States
Cleveland Clinic Florida
RecruitingWeston, Florida, 33331, United States
Atlanta Gastroenterology Associates
RecruitingAtlanta, Georgia, 30342, United States
Randomize Now, LLC
RecruitingAtlanta, Georgia, 30308, United States
Gastroenterology Associates of Central Georgia
RecruitingMacon, Georgia, 31201, United States
Grand Teton Research Group, PLLC
RecruitingIdaho Falls, Idaho, 83404, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
RecruitingGlenview, Illinois, 60026, United States
GI Alliance - Gurnee
RecruitingGurnee, Illinois, 60031, United States
Gastro Health Partners, LLC
RecruitingNew Albany, Indiana, 47150, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
RecruitingWichita, Kansas, 67226, United States
One GI: GHP - Gastroenterology Health Partners Louisville
RecruitingLouisville, Kentucky, 40218, United States
Louisiana Research Center - GastroIntestinal Associates
RecruitingShreveport, Louisiana, 71105, United States
Allied Gastrointestinal Associates, PA
RecruitingFlowood, Mississippi, 39232, United States
Delta Gastroenterology & Endoscopy Center
RecruitingSouthaven, Mississippi, 38671, United States
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
RecruitingLebanon, New Hampshire, 03756, United States
Ellipsis Research Group
RecruitingBrooklyn, New York, 11215, United States
NYU Inflammatory Bowel Disease Center
RecruitingNew York, New York, 10016, United States
Weill Cornell Medical College
RecruitingNew York, New York, 10021, United States
DiGiovanna Inst for Med Ed&Res
RecruitingNorth Massapequa, New York, 11758, United States
Queens Village Medical Care
RecruitingQueens Village, New York, 11428, United States
Gastroenterology Group Of Rochester, LLP
RecruitingRochester, New York, 14618, United States
James J Peters Veterans Administration Medical Center - NAVREF
RecruitingThe Bronx, New York, 10468, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
RecruitingCharlotte, North Carolina, 28207, United States
Omega Research North Carolina, LLC
RecruitingFuquay-Varina, North Carolina, 27526, United States
Peters Medical Research (PMR), LLC
RecruitingHigh Point, North Carolina, 27260, United States
Dayton Gastroenterology, Inc.
RecruitingBeavercreek, Ohio, 45440, United States
University of Cincinnati Hospital
RecruitingCincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
RecruitingCleveland, Ohio, 44195, United States
Ohio Gastroenterology Group
RecruitingColumbus, Ohio, 43202, United States
Ohio State University
RecruitingColumbus, Ohio, 43210, United States
Gastro Intestinal Research Institute of Northern Ohio
RecruitingWestlake, Ohio, 44145, United States
Frontier Clinical Re search, LLC
RecruitingUniontown, Pennsylvania, 15401, United States
University Gastroenterology
RecruitingProvidence, Rhode Island, 02904, United States
Gastroenterology Associates
RecruitingGreenville, South Carolina, 29607, United States
Gastro One
RecruitingCordova, Tennessee, 38018, United States
Uni of Texas Medical Branch
RecruitingGalveston, Texas, 77555, United States
GI Alliance
RecruitingGarland, Texas, 75044, United States
Amel Med LLC
RecruitingGeorgetown, Texas, 78628, United States
Cano Medical Center
RecruitingHarlingen, Texas, 78550, United States
Texas Digestive Specialists
RecruitingHarlingen, Texas, 78550, United States
Integrity Advanced Therapeutics PLLC
Not Yet RecruitingHouston, Texas, 77090, United States
GI Alliance - Bay Area Gastroenterology
RecruitingLubbock, Texas, 79410, United States
TDDC dba GI Alliance Research
RecruitingMansfield, Texas, 76063, United States
Southern Star Research Institute, LLC.
RecruitingSan Antonio, Texas, 78229, United States
Baylor Scott and White Medical Center
RecruitingTemple, Texas, 76508, United States
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
University of Texas Health Center at Tyler
RecruitingTyler, Texas, 75708, United States
TDDC GI Alliance research Webster
RecruitingWebster, Texas, 77598, United States
Gastroenterology Associates of Tidewater
RecruitingChesapeake, Virginia, 23320, United States
Emeritas Research Group
RecruitingLansdowne Town Center, Virginia, 20176, United States
Gastroenterology Consultants of SWVA
RecruitingRoanoke, Virginia, 24018, United States
This study also lists 129 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: GA45330 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
Registry dates
- First posted
- Sep 19, 2024
- Primary completion
- Jan 30, 2027
- Overall completion
- Jan 30, 2031
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.