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Second-line treatment with upadacitinib or risankizumab for adults with Crohn's disease

Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)

Observational AbbVie · NCT07073079

This project will test how well upadacitinib or risankizumab work as second-line treatments for adults with moderate-to-severe Crohn's disease who previously used a TNF inhibitor.

Quick facts

Study typeObservational
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsrisankizumab, upadacitinib
Locations23 sites (Castellana Grotte, Bari and 22 other locations)
Trial IDNCT07073079 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world study enrolling about 250 adults across roughly 25 sites in Italy who are prescribed upadacitinib or risankizumab by their treating physician. The study includes a retrospective review of up to 2 years of prior medical records and a prospective follow-up of up to 18 months after enrollment, with treatments given per local label and routine care. No experimental interventions or additional study-only procedures are required, and participants follow their usual clinical visits. Data collected will describe treatment responses, safety events, and treatment patterns for these two approved second-line options.

Who should consider this trial

Good fit: Adults with moderate-to-severe Crohn's disease who previously received a TNF inhibitor as first-line therapy for at least six months and have clinical documentation available are the intended participants.

Not a fit: Patients with contraindications from the local upadacitinib or risankizumab labels, prior exposure to upadacitinib/risankizumab or other non-TNFi bDMARDs for Crohn's disease, or those with only mild disease are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, the results could help doctors choose between upadacitinib and risankizumab as second-line options and improve real-world treatment decisions for patients who failed TNF inhibitors.

How similar studies have performed: Both upadacitinib and risankizumab have shown positive results in clinical trials and are approved for Crohn's disease, but direct real-world comparisons as second-line therapies after TNF inhibitors are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes
* Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy

Exclusion Criteria:

* Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label
* Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD

Where this trial is running

Castellana Grotte, Bari and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseUpadacitinibRisankizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.