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New hope for Crohn's patients: second-line drugs tested in real-world study

NCT ID NCT07073079

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 250 people with moderate-to-severe Crohn's disease who are switching to either upadacitinib or risankizumab after a first treatment didn't work well enough. Researchers will see if these drugs help patients achieve remission without needing steroids over 18 months. The goal is to understand how well these approved drugs work in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib and risankizumab
What this could lead to
If successful, this study could show that switching to these drugs helps more people with Crohn's disease achieve remission without needing steroids.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only follows people for 18 months, so long-term effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult participants with Crohn's Disease

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Turin, Torino, 10128, Italy

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

    RECRUITING

    Turin, Piedmont, 10126, Italy

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

    RECRUITING

    Bari, 70124, Italy

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

    RECRUITING

    Catania, 95123, Italy

  • Azienda Ospedaliera G. Brotzu /ID# 275125

    RECRUITING

    Cagliari, 09047, Italy

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

    RECRUITING

    Palermo, 90146, Italy

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788

    RECRUITING

    Naples, Napoli, 80138, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654

    RECRUITING

    Rome, Roma, 00133, Italy

  • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571

    RECRUITING

    Catanzaro, 88100, Italy

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

    RECRUITING

    Monserrato, Cagliari, 09042, Italy

  • Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460

    RECRUITING

    Pescara, 65124, Italy

  • Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966

    RECRUITING

    Roma, 00186, Italy

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

    RECRUITING

    Milan, 20122, Italy

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

    RECRUITING

    Monza, Monza E Brianza, 20052, Italy

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

    RECRUITING

    Rome, Roma, 00168, Italy

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

    RECRUITING

    Roma, 00128, Italy

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

    RECRUITING

    San Giovanni Rotondo, Foggia, 71013, Italy

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

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS Istituto Clinico Humanitas /ID# 274489

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462

    RECRUITING

    Negrar, Verona, 37024, Italy

  • IRCCS Ospedale San Raffaele /ID# 274458

    RECRUITING

    Milan, Milano, 20132, Italy

  • Ospedale San Martino /ID# 274529

    RECRUITING

    Genova, 16132, Italy

  • Ospedale Sandro Pertini /ID# 275023

    RECRUITING

    Rome, Roma, 00157, Italy

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

    RECRUITING

    Castellana Grotte, Bari, 70013, Italy

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