Moderately to Severely Active Crohns Disease
Afimkibart for Children With Moderately to Severely Active Crohn's Disease
This randomized phase 3 study is investigating afimkibart induction and maintenance therapy, including intravenous infusions followed by subcutaneous injections, in children ages 2–17 with moderately to severely active Crohn's disease.
Registry title: A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Afimkibart
- Design
- Randomized · Quadruple
- Central study contact
- Reference Study ID Number: CP45906 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
How does afimkibart behave in the body, and what do its effectiveness and safety look like during induction and maintenance treatment in children with moderately to severely active Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2 through 17.
- The study is looking for children who weigh at least 10 kilograms.
- The study is looking for children with moderately to severely active Crohn's disease confirmed through specified clinical and centrally read endoscopic measures.
- The study is looking for children whose Crohn's disease did not respond adequately, stopped responding, or was not tolerated with at least one listed conventional or advanced therapy.
Participation overview
What participation may involve
Participants are randomly assigned to one of two afimkibart dose groups and receive the drug by intravenous infusion followed by subcutaneous injection. The study assesses Crohn's disease activity, endoscopic findings, laboratory markers, drug concentrations, and adverse events. What participation may involve: - Receive afimkibart through an intravenous infusion and later through a subcutaneous injection. - Complete assessments of Crohn's disease activity, including the Pediatric Crohn's Disease Activity Index and Crohn's Disease Activity Index. - Undergo endoscopic assessments used to evaluate response, remission, ulcers, and tissue-level improvement. - Provide samples or measurements for fecal calprotectin, the Mucosal Inflammation Noninvasive Index, and serum afimkibart concentration assessments. - Be monitored for the incidence and severity of adverse events.
Study interventions
What participants may receive or do
- Afimkibart: Participants in both study groups receive afimkibart, first through an intravenous infusion and later through an injection under the skin. The groups use different dose regimens, but the record does not report the dose amounts.
Study design
How the comparison works
This is a phase 3, multi-center treatment study with two parallel afimkibart dose groups. Participants remain in their assigned group through the study's induction and maintenance phases. Participants are randomly assigned to one of two afimkibart dose groups. The study uses quadruple masking: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The registry lists two experimental afimkibart dose groups and does not list a separate active-comparator or untreated control group. No placebo intervention or placebo arm is listed in the registry record.
Reported activities
Procedures and tests
- Afimkibart intravenous infusion.
- Afimkibart subcutaneous injection.
- Ileocolonoscopy to confirm active Crohn's disease and measure the Simple Endoscopic Score for Crohn's Disease.
- Pediatric Crohn's Disease Activity Index assessment.
- Endoscopic assessments of response, remission, and ulcer-free status.
- Fecal calprotectin measurement at baseline, Week 12, and Week 52.
- Mucosal Inflammation Noninvasive Index score assessment at baseline, Week 12, and Week 52.
- Histologic assessment for tissue-level improvement at Week 52.
- Blood sampling to measure serum concentrations of afimkibart.
- Monitoring of adverse-event incidence and severity.
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
- Participants must weigh at least 10 kilograms.
- Active Crohn's disease must be confirmed by ileocolonoscopy.
- Crohn's disease must be moderately to severely active, with a Pediatric Crohn's Disease Activity Index score of at least 30 and a centrally read Simple Endoscopic Score for Crohn's Disease of at least 6, or at least 4 for isolated ileal disease.
- There must have been an inadequate response, loss of response, or intolerance to at least one listed conventional or advanced Crohn's disease therapy.
Possible reasons someone may not be able to join
- Children with a monogenic disorder related to infant-onset inflammatory bowel disease are excluded.
- The study excludes children with a history of at least three bowel resections and more than two missing segments among the five listed bowel regions.
- Several other current intestinal diagnoses are excluded, including ulcerative colitis, indeterminate or unclassified inflammatory bowel disease, specified forms of colitis, active diverticular disease, and abdominal, intra-abdominal, or perianal fistula or abscess.
- Children with symptomatic bowel strictures, fulminant colitis, or toxic megacolon are excluded.
- Children with an abdominal or perianal abscess are excluded.
- A current diagnosis or suspicion of primary sclerosing cholangitis is exclusionary.
Important unknowns
What the record does not make clear
- The record gives assessment timepoints but does not state the number, frequency, length, or setting of study visits.
- Some safety and drug-concentration outcomes are measured for approximately 5.5 years, but the record does not clearly state each participant's total time in the study.
- The record does not state which existing Crohn's disease medicines may continue during the study.
- The record does not report whether any medicines must be stopped before afimkibart begins or how long any washout would last.
- The record does not describe what treatment is available if Crohn's disease worsens or does not improve.
- The record requires centrally read ileocolonoscopy for entry and reports endoscopic outcomes through Week 52, but it does not clearly state the total number or full schedule of endoscopies.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants or families receive compensation or expense reimbursement.
- The record lists study locations but does not describe travel or lodging support.
- The record does not say whether any visits or assessments can occur remotely or through a local clinician.
- The record does not describe whether afimkibart may remain available after study treatment ends.
Before contacting the site
Questions for the study team
- What are the exact afimkibart doses, infusion and injection schedules, and rules for moving from intravenous to subcutaneous treatment?
- How long would an individual child participate, and what follow-up continues after treatment ends?
- How many in-person visits, infusions, injections, blood draws, stool collections, and ileocolonoscopies are required?
- Which current Crohn's disease treatments may continue, and are any washout or stable-dose periods required?
- What happens if Crohn's disease worsens, and which rescue treatments are permitted?
- What risks, side effects, and monitoring requirements are known for afimkibart in children?
- Which study-related costs, travel expenses, or family expenses are covered or reimbursed?
- Is the preferred study location currently enrolling this child's age and dose cohort, and can any activities occur closer to home?
Before changing care
Questions for your gastroenterologist
- How stable is the child's Crohn's disease now, and what are the risks of changing the current treatment plan to meet this study's requirements?
- Which approved treatment alternatives remain reasonable to consider before deciding whether to contact the study team?
- Could stopping, washing out, or changing any current medicine create a risk of worsening disease?
- Are repeated ileocolonoscopies, blood sampling, infusions, and injections appropriate in this child's clinical situation?
- How should the gastroenterology team and research team coordinate routine care, flare management, and urgent decisions if the family explores the study?
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, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Study design and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- CP45906
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
Experimental
Afimkibart Dose A
Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.
Interventions: Drug: Afimkibart
Experimental
Afimkibart Dose B
Participants will receive Afimkibart IV followed by Afimkibart SC.
Interventions: Drug: Afimkibart
Interventions
Drug
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (4)
- Body weight \>= 10 kilogram (kg)Registry-derived · unreviewed
- Active CD confirmed by endoscopy (ileocolonoscopy)Registry-derived · unreviewed
- Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopyRegistry-derived · unreviewed
- Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)Registry-derived · unreviewed
Exclusion criteria (6)
- Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)Registry-derived · unreviewed
- History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectumRegistry-derived · unreviewed
- Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.Registry-derived · unreviewed
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolonRegistry-derived · unreviewed
- Presence of abdominal or perianal abscessRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-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 per Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame: At Week 52
Primary outcome
Percentage of Participants With Endoscopic Response
Time frame: At Week 52
Secondary outcome
Percentage of Participants With Clinical Remission
Time frame: At Week 12 and Week 52
Secondary outcome
Percentage of Participants With Clinical Response
Time frame: At Week 12 and Week 52
Secondary outcome
Percentage of Participants With CDAI Remission
Time frame: At Week 12 and Week 52
Secondary outcome
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 12 and Week 52
Secondary outcome
Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score
Time frame: Baseline, Week 12 and Week 52
Secondary outcome
Percentage of Participants With Endoscopic Remission
Time frame: At Week 52
Secondary outcome
Percentage of Participants With Corticosteroid-Free Clinical Remission
Time frame: At Week 52
Secondary outcome
Percentage of Participants with Maintenance of Remission
Time frame: At Week 12 and Week 52
Secondary outcome
Percentage of Participants With Histologic Improvement
Time frame: At Week 52
Secondary outcome
Percentage of Participants With Ulcer-Free Endoscopy
Time frame: At Week 52
Secondary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to Approximately 5.5 Years
Secondary outcome
Serum Concentration of Afimkibart
Time frame: Up to Approximately 5.5 Years
Recruiting locations in the United States
NYU Langone Health
RecruitingNew York, New York, 10016, United States
This study also lists 9 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: CP45906 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
- Dec 23, 2025
- Primary completion
- May 31, 2030
- Overall completion
- May 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.