A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting

Recruiting now

Conditions studied: Crohn's Disease

In brief

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting. Upadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy. Participants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months. No additional burden for participants in this trial is expected.

Key facts

Study ID

NCT07073079

Run by

AbbVie

People needed

250

Starts

2025-07-14

Expected to finish

2027-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706 — Castellana Grotte, Bari, Italy (enrolling)
• Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216 — Monserrato, Cagliari, Italy (enrolling)
• Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669 — San Giovanni Rotondo, Foggia, Italy (enrolling)
• IRCCS Istituto Clinico Humanitas /ID# 274489 — Rozzano, Lombardy, Italy (enrolling)
• IRCCS Ospedale San Raffaele /ID# 274458 — Milan, Milano, Italy (enrolling)
• Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682 — Monza, Monza E Brianza, Italy (enrolling)
• Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 — Naples, Napoli, Italy (enrolling)
• Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 — Naples, Napoli, Italy (enrolling)
• A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461 — Turin, Piedmont, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654 — Rome, Roma, Italy (enrolling)
• Ospedale Sandro Pertini /ID# 275023 — Rome, Roma, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530 — Rome, Roma, Italy (enrolling)
• A.O. Ordine Mauriziano di Torino /ID# 274459 — Turin, Torino, Italy (enrolling)
• IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462 — Negrar, Verona, Italy (enrolling)
• A.O.U. Consorziale Policlinico di Bari /ID# 274662 — Bari, Italy (enrolling)
• IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161 — Bologna, Italy (enrolling)
• Azienda Ospedaliera G. Brotzu /ID# 275125 — Cagliari, Italy (enrolling)
• AOU Policlinico G. Rodolico - San Marco /ID# 274909 — Catania, Italy (enrolling)
• Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571 — Catanzaro, Italy (enrolling)
• Ospedale San Martino /ID# 274529 — Genova, Italy (enrolling)
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618 — Milan, Italy (enrolling)
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964 — Palermo, Italy (enrolling)
• Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460 — Pescara, Italy (enrolling)
• Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488 — Roma, Italy (enrolling)
• Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966 — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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