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Taking people in BulgariaPhase 3

Testing afimkibart for moderately to severely active Crohn's disease

Tests afimkibart against placebo in people with moderately to severely active Crohn's disease.

Key facts

Who runs it
Hoffmann-La Roche
Where
Burgas, Gorna Oryahovitsa, Plovdiv, and Sofia, BulgariaSee the 5 sitesAlso in 37 other countries, 376 sites
Registry title
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Status
Recruiting
Phase
Phase 3
People taking part
600 people, planned
Started
17 Mar 2025
Expected to end
31 Dec 2033
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Afimkibart
  • Placebo
Record updated
13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with moderately to severely active Crohn's disease. It tests afimkibart against placebo, as first and then ongoing treatment.

Age
16 to 80 years
Sex
All sexes can join.
Disease stage
Confirmed Crohn's disease that is moderately to severely active.
Earlier treatment
People must have had an inadequate response, lost response and/or not tolerated at least one protocol-specified conventional or advanced Crohn's disease treatment. Anti-TL1A therapy exposure is not allowed.

Main reasons for not taking part

  • Ulcerative colitis or other types of colitis
  • 3 or more bowel resections, short bowel syndrome, ileostomy, colostomy or ileoanal pouch
  • Symptomatic bowel strictures, abscess, or certain types of fistulas
  • Pregnancy or breastfeeding
  • Infection with C. difficile, CMV, HIV, hepatitis B or hepatitis C, or active or inadequately treated tuberculosis

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Confirmed diagnosis of CD
  • Moderately to severely active CD
  • Bodyweight >= 40 kilogram (kg)
  • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
  • Males and females of childbearing potential must meet protocol criteria for contraception requirements

Who cannot take part

  • Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
  • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
  • Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
  • Diagnosis of short gut or short bowel syndrome
  • Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
  • Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
  • History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  • Presence of an ileostomy, colostomy or ileoanal pouch
  • Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Presence of abdominal or perianal abscess
  • Current diagnosis or suspicion of primary sclerosing cholangitis
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 80 years old?

Where in Bulgaria

Also in 37 other countries, 376 sites

  • Multiprofile Hospital For Active Treatment Burgasmed Ltd.Burgas, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOODGorna Oryahovitsa, BulgariaTaking people
  • MBAL Sveta Karidad EADPlovdiv, BulgariaTaking people
  • Medical Centre Futuremeds EOODPlovdiv, BulgariaTaking people
  • Tokuda HospitalSofia, BulgariaTaking people

About the trial

What the trial wants to find out

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

The 3 groups in the trial

  • Arm 1: AfimkibartTreatment being tested

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

    Treatment: Afimkibart

  • Arm 2: AfimkibartTreatment being tested

    Participants will receive afimkibart IV followed by afimkibart SC injection.

    Treatment: Afimkibart

  • Arm 3: PlaceboPlacebo, for comparison

    Participants will receive placebo IV followed by placebo SC.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Plain-language title
Testing afimkibart for moderately to severely active Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06819878, who can take part
Record updated
13 November 2026