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RecruitingNCT07298421SIBERITE-PEDSUpdated Oct 6, 2026

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 interventional study of Afimkibart in Moderately to Severely Active Crohns Disease, sponsored by Hoffmann-La Roche. Recruiting at 17 sites in 8 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Updated Oct 6, 20263 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Moderately to Severely Active Crohns Disease
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Afimkibart Dose A

    Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

    Drug: Afimkibart

  • Experimental
    Afimkibart Dose B

    Participants will receive Afimkibart IV followed by Afimkibart SC.

    Drug: Afimkibart

Interventions

  • DrugAfimkibart

    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

    Also known as: RO7790121, PF-06480605, RVT-3101

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)

    Time frame: At Week 52

  2. Percentage of Participants With Endoscopic Response

    Time frame: At Week 52

Secondary outcomes

  1. Percentage of Participants With Clinical Remission

    Time frame: At Week 12 and Week 52

  2. Percentage of Participants With Clinical Response

    Time frame: At Week 12 and Week 52

  3. Percentage of Participants With CDAI Remission

    Time frame: At Week 12 and Week 52

  4. Change From Baseline in Fecal Calprotectin

    Time frame: Baseline, Week 12 and Week 52

  5. Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score

    Time frame: Baseline, Week 12 and Week 52

  6. Percentage of Participants With Endoscopic Remission

    Time frame: At Week 52

  7. Percentage of Participants With Corticosteroid-Free Clinical Remission

    Time frame: At Week 52

  8. Percentage of Participants with Maintenance of Remission

    Time frame: At Week 12 and Week 52

  9. Percentage of Participants With Histologic Improvement

    Time frame: At Week 52

  10. Percentage of Participants With Ulcer-Free Endoscopy

    Time frame: At Week 52

  11. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to Approximately 5.5 Years

  12. Serum Concentration of Afimkibart

    Time frame: Up to Approximately 5.5 Years

07

Study locations

17 of 17 sites recruiting
  • NYU Langone Health
    New York, New York 10016, United States
    Recruiting
  • Mater Hospital Brisbane
    South Brisbane, Queensland 4101, Australia
    Recruiting
  • Royal Children's Hospital
    Parkville, Victoria 3052, Australia
    Recruiting
  • Perth Children's Hospital
    Nedlands, Western Australia 6009, Australia
    Recruiting
  • Santa Casa de Misericordia de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-074, Brazil
    Recruiting
  • CECIP - Centro de Estudos Clínicos do Interior Paulista
    Jaú, São Paulo 17201-130, Brazil
    Recruiting
  • BR Trials - Pesquisa Clínica
    São Paulo, São Paulo 01236-030, Brazil
    Recruiting
  • Centro de Investigación Clínica Acelerada, S.C
    Mexico City, Mexico CITY (federal District) 07369, Mexico
    Recruiting
  • FAICIC Clinical Research
    Veracruz, 91900, Mexico
    Recruiting
  • Emmed Research
    Pretoria, Gauteng 84, South Africa
    Recruiting
  • IATROS International
    Bloemfontein, 9301, South Africa
    Recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
  • Chulalongkorn University
    Bangkok, 10330, Thailand
    Recruiting
  • Siriraj Hospital
    Bangkok, 10700, Thailand
    Recruiting
  • Ramathibodi Hospital
    Bangkok, Thailand
    Recruiting
  • King's College Hospital
    London, SE5 9RS, United Kingdom
    Recruiting
  • Sheffield Childrens Hospital
    Sheffield, S10 2TH, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added
Show 3 added (1 Australia, 1 Brazil, 1 United Kingdom)
  • Mater Hospital Brisbane · South Brisbane, Australia
  • Santa Casa de Misericordia de Porto Alegre · Porto Alegre, Brazil
  • King's College Hospital · London, United Kingdom
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    3 sites added
    Show 3 added (1 Australia, 1 Brazil, 1 United Kingdom)
    • Mater Hospital Brisbane · South Brisbane, Australia
    • Santa Casa de Misericordia de Porto Alegre · Porto Alegre, Brazil
    • King's College Hospital · London, United Kingdom
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07298421
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 23, 2025
Start date
Aug 18, 2026
Primary completion
May 31, 2030 (estimated)
Completion
May 30, 2031 (estimated)
Last update
Oct 6, 2026

Study contacts

Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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