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Clinical Trials in Italy / NCT07073079
Recruiting Observational

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

NCT07073079 · tracked via the Priya Life Science Italy tracker
Sponsor
AbbVie
Phase
Observational
Started
2025-07-14
Last updated
2026-06-24

Condition(s) studied

Crohn's Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of Participants who Achieve Corticosteroids (CS) Free Remission — Month 12
    CS free remission is defined as clinical remission with Harvey Bradshaw Index (HBI) \<4 and absence of corticosteroid use since at least three months prior to month 12.

Trial sites (25)

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

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Other trials for the same condition

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients Active, not recruiting
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis Recruiting
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073079 on ClinicalTrials.gov ↗ ← All trials in Italy