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

Last updated: February 23, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Ulcerative Colitis

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT07073079
P25-397
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmedby clinical, and/or endoscopic/histological indexes

  • Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fistline (1L) therapy for at least 6 months; clinical documentation available in medicalcharts for the previous 2 years or since the beginning of the 1L therapy

Exclusion

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 orinvestigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) forCD

Study Design

Total Participants: 250
Study Start date:
July 14, 2025
Estimated Completion Date:
December 31, 2027

Study Description

The retrospective phase will be up to 2 years prior to enrollment to the study, the prospective phase will be up to 18 months after enrollment.

Connect with a study center

  • Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706

    Castellana Grotte 3179656, Bari 70013
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216

    Monserrato 2524084, Cagliari 09042
    Italy

    Active - Recruiting

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669

    San Giovanni Rotondo 3168234, Foggia 71013
    Italy

    Active - Recruiting

  • Ospedale San Martino /ID# 274529

    Genoa 3176219, Genova 16132
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas /ID# 274489

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas /ID# 274489

    Rozzano 3168837, Lombardy 3174618 20089
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele /ID# 274458

    Milan 3173435, Milano 20132
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682

    Monza 3172629, Monza E Brianza 20052
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II /ID# 274570

    Naples 3172394, Napoli 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788

    Naples 3172394, Napoli 80138
    Italy

    Active - Recruiting

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461

    Turin 3165524, Piedmont 3170831 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654

    Rome 3169070, Roma 00133
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530

    Rome 3169070, Roma 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 274530

    Rome 3169070, Roma 00168
    Italy

    Active - Recruiting

  • Ospedale Sandro Pertini /ID# 275023

    Rome 3169070, Roma 00157
    Italy

    Active - Recruiting

  • A.O. Ordine Mauriziano di Torino /ID# 274459

    Turin, Torino 10128
    Italy

    Site Not Available

  • A.O. Ordine Mauriziano di Torino /ID# 274459

    Turin 3165524, Torino 10128
    Italy

    Active - Recruiting

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462

    Negrar 3172338, Verona 37024
    Italy

    Active - Recruiting

  • A.O.U. Consorziale Policlinico di Bari /ID# 274662

    Bari 3182351, 70124
    Italy

    Active - Recruiting

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • AOU Policlinico G. Rodolico - San Marco /ID# 274909

    Catania 2525068, 95123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571

    Catanzaro 2525059, 88100
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274618

    Milan 6951411, 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964

    Palermo 2523920, 90146
    Italy

    Active - Recruiting

  • Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966

    Roma 8957247, 00186
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488

    Roma 8957247, 00128
    Italy

    Active - Recruiting

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