Moderately to Severely Active Crohns DiseasePhase 3SIBERITE-PEDSNCT07298421
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
A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Crohns Disease, run by Hoffmann-La Roche at 19 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Moderately to Severely Active Crohns Disease
- What is being tested?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 18 Aug 2026to 30 May 2031
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Body weight >= 10 kilogram (kg)
- Active CD confirmed by endoscopy (ileocolonoscopy)
- 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 ileocolonoscopy
- 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)
Who cannot join
- Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
- History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- 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.
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Current diagnosis or suspicion of primary sclerosing cholangitis
Trial locations and contacts
19 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: CP45906 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
19 sites in 8 countries
Australia3 sites, 3 recruiting
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6009
- Recruiting
Royal Children's Hospital
Parkville, Victoria, 3052
- Recruiting
Mater Hospital Brisbane
South Brisbane, Queensland, 4101
Brazil3 sites, 3 recruiting
- Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17201-130
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
- Recruiting
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 01236-030
Thailand3 sites, 3 recruiting
- Recruiting
Chulalongkorn University
Bangkok, 10330
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Ramathibodi Hospital
Bangkok
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
- Recruiting
King's College Hospital
London, SE5 9RS
- Recruiting
Sheffield Childrens Hospital
Sheffield, S10 2TH
United States2 sites, 2 recruiting
- Recruiting
Texas Digestive Specialists
Harlingen, Texas, 78550
- Recruiting
NYU Langone Health
New York, New York, 10016
Mexico2 sites, 2 recruiting
- Recruiting
Centro de Investigación Clínica Acelerada, S.C
Mexico City, Mexico CITY (federal District), 07369
- Recruiting
FAICIC Clinical Research
Veracruz, 91900
South Africa2 sites, 2 recruiting
- Recruiting
IATROS International
Bloemfontein, 9301
- Recruiting
Emmed Research
Pretoria, Gauteng, 84
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease
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).
- Being tested
- Afimkibart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called RO7790121, PF-06480605, RVT-3101
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart Dose A | Experimental | Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Afimkibart Dose B | Experimental | Participants will receive Afimkibart IV followed by Afimkibart SC. Receives: Drug: Afimkibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Measured: At Week 52
Percentage of Participants With Endoscopic Response
Measured: At Week 52
Secondary outcomes (12)
Percentage of Participants With Clinical Remission
Measured: At Week 12 and Week 52
Percentage of Participants With Clinical Response
Measured: At Week 12 and Week 52
Percentage of Participants With CDAI Remission
Measured: At Week 12 and Week 52
Change From Baseline in Fecal Calprotectin
Measured: Baseline, Week 12 and Week 52
Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score
Measured: Baseline, Week 12 and Week 52
Percentage of Participants With Endoscopic Remission
Measured: At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission
Measured: At Week 52
Percentage of Participants with Maintenance of Remission
Measured: At Week 12 and Week 52
Percentage of Participants With Histologic Improvement
Measured: At Week 52
Percentage of Participants With Ulcer-Free Endoscopy
Measured: At Week 52
Incidence and Severity of Adverse Events (AEs)
Measured: Up to Approximately 5.5 Years
Serum Concentration of Afimkibart
Measured: Up to Approximately 5.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start18 Aug 2026
- Primary completion31 May 2030 (estimated)
- Study completion30 May 2031 (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 Crohns DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298421
- Sponsor's protocol ID
- CP45906
- Other IDs
- 2025-523318-96-00, 2025
- Acronym
- SIBERITE-PEDS
- Status last verified
- Nov 2026
- First submitted
- 19 Dec 2025
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT07298421
- Acronym / sponsor ID
- SIBERITE-PEDS / CP45906
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 23 Dec 2025 (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.
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
- 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 Dose A | Experimental | Drug: AfimkibartParticipants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. |
| Afimkibart Dose B | Experimental | Drug: AfimkibartParticipants will receive Afimkibart IV followed by Afimkibart SC. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Body weight >= 10 kilogram (kg)
- Active CD confirmed by endoscopy (ileocolonoscopy)
- 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 ileocolonoscopy
- 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)
Key exclusion criteria (6 listed)
- Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
- History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- 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.
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
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: RO7790121, PF-06480605, RVT-3101Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. | Drug | Afimkibart Dose A, Afimkibart Dose B |
Primary outcome
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame: At Week 52
Percentage of Participants With Endoscopic Response
Time frame: At Week 52
12 secondary outcomes
Percentage of Participants With Clinical Remission
Time frame: At Week 12 and Week 52
Percentage of Participants With Clinical Response
Time frame: At Week 12 and Week 52
Percentage of Participants With CDAI Remission
Time frame: At Week 12 and Week 52
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 12 and Week 52
Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score
Time frame: Baseline, Week 12 and Week 52
Percentage of Participants With Endoscopic Remission
Time frame: At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission
Time frame: At Week 52
Percentage of Participants with Maintenance of Remission
Time frame: At Week 12 and Week 52
Percentage of Participants With Histologic Improvement
Time frame: At Week 52
Percentage of Participants With Ulcer-Free Endoscopy
Time frame: At Week 52
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to Approximately 5.5 Years
Serum Concentration of Afimkibart
Time frame: Up to Approximately 5.5 Years
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 5 Nov 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
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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: CP45906 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
19 sites in 8 countries: 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 Crohns Disease, run by Hoffmann-La Roche at 19 sites in 8 countries.
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 4 inclusion and 6 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, Brazil, Thailand, United Kingdom, United States and 3 more countries. 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. 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: CP45906 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 per Pediatric Crohn's Disease Activity Index (PCDAI) (time frame: At Week 52). The study lists 2 primary outcomes in all. 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 5 Nov 2026.