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Taking people in ItalyPhase 2

Tests targeted medicines in adults with moderate to severe Crohn's disease

Tests risankizumab, lutikizumab, trosunilimab and ABBV-8736 in adults with moderate to severe Crohn's disease.

Key facts

Who runs it
AbbVie
Where
Catanzaro, Messina, Milan, Monserrato, Negrar, Rome, Rozzano, San Giovanni Rotondo, and Turin, ItalySee the 11 sitesAlso in 32 other countries, 243 sites
Registry title
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Status
Recruiting
Phase
Phase 2
People taking part
590 people, planned
Started
4 Sept 2024
Expected to end
Jan 2030
Type of study
Interventional, 8 groups
Treatments tested
  • Risankizumab
  • Lutikizumab
  • Trosunilimab
  • ABBV-8736
Record updated
25 September 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 adults with moderate to severe Crohn's disease who did not respond well to, or could not tolerate, earlier treatments.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Crohn's disease confirmed for at least 3 months, with biopsy results on file. Moderate to severe activity: CDAI of 220 or more, and signs of inflammation in the bowel lining on endoscopy (SES-CD of 6 or more, or 4 or more for disease only in the ileum).
Earlier treatment
People must not have responded well to, or not tolerated, conventional therapies and/or targeted therapies (biologics or targeted small molecules).

Main reasons for not taking part

  • History of intolerance to p19 inhibitors, including risankizumab
  • Current ulcerative colitis or indeterminate colitis
  • Current ostomy or ileoanal pouch
  • Current short gut or short bowel syndrome
  • Bowel surgery to remove part of the bowel in the past 3 months

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Participants' body weight must be >= 40 kg at Baseline
  • Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available
  • CDAI >= 220 at Baseline
  • Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader
  • Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules

Who cannot take part

  • Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline
  • Participant with history of intolerance to p19 inhibitors, including risankizumab

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 18 and 75 years old?

Where in Italy

Also in 32 other countries, 243 sites

  • Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyTaking people
  • Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Di CagliariMonserrato, ItalyTaking people
  • IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
  • Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
  • Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people

About the trial

What the trial wants to find out

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

Read full original descriptionShow less

The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide.

Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

The 8 groups in the trial

  • Monotherapy: RisankizumabTreatment being tested

    Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.

    Treatment: Risankizumab

  • Combination Therapy: Risankizumab and TrosunilimabTreatment being tested

    Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.

    Treatment: Risankizumab and Trosunilimab

  • Monotherapy: TrosunilimabTreatment being tested

    Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.

    Treatment: Trosunilimab

  • Combination Therapy: Risankizumab and LutikizumabTreatment being tested

    Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.

    Treatment: Risankizumab and Lutikizumab

  • Monotherapy: LutikizumabTreatment being tested

    Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.

    Treatment: Lutikizumab

  • Monotherapy: ABBV-8736 - OUS OnlyTreatment being tested

    Participants will receive ABBV-8736 Dose A as IV infusion.

    Treatment: ABBV-8736

  • Combination Therapy: ABBV-466 (Risankizumab/Trosunilimab)Treatment being tested

    Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose C as IV infusion and trosunilimab Dose D as SC injection.

    Treatment: Risankizumab and Trosunilimab

  • Long-Term Extension: Risankizumab MonotherapyTreatment being tested

    Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B and Dose C as SC injection for up to 72 weeks.

    Treatment: Risankizumab

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 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
Plain-language title
Tests targeted medicines in adults with moderate to severe 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 NCT06548542, who can take part
Record updated
25 September 2026