Crohn's DiseaseCROHNOSNCT07073079
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
An observational study of Crohn's Disease, run by AbbVie at 25 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 250 participants
- Where
- 25 sitesItaly
- Study dates
- 14 Jul 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with Crohn's Disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
Italy25 sites, 25 recruiting
- Recruiting
A.O.U. Consorziale Policlinico di Bari /ID# 274662
Bari, 70124
- Recruiting
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161
Bologna, 40138
- Recruiting
Azienda Ospedaliera G. Brotzu /ID# 275125
Cagliari, 09047
- Recruiting
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
Castellana Grotte, Bari, 70013
- Recruiting
AOU Policlinico G. Rodolico - San Marco /ID# 274909
Catania, 95123
- Recruiting
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571
Catanzaro, 88100
- Recruiting
Ospedale San Martino /ID# 274529
Genova, 16132
- Recruiting
IRCCS Ospedale San Raffaele /ID# 274458
Milan, Milano, 20132
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618
Milan, 20122
- Recruiting
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
Monserrato, Cagliari, 09042
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
Monza, Monza E Brianza, 20052
- Recruiting
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570
Naples, Napoli, 80131
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788
Naples, Napoli, 80138
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462
Negrar, Verona, 37024
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964
Palermo, 90146
- Recruiting
Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460
Pescara, 65124
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488
Roma, 00128
- Recruiting
Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966
Roma, 00186
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654
Rome, Roma, 00133
- Recruiting
Ospedale Sandro Pertini /ID# 275023
Rome, Roma, 00157
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530
Rome, Roma, 00168
- Recruiting
IRCCS Istituto Clinico Humanitas /ID# 274489
Rozzano, Lombardy, 20089
- Recruiting
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
San Giovanni Rotondo, Foggia, 71013
- Recruiting
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461
Turin, Piedmont, 10126
- Recruiting
A.O. Ordine Mauriziano di Torino /ID# 274459
Turin, Torino, 10128
About this study
Official title: Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
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.
Read more
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.
Read the detailed 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.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Upadacitinib, Risankizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months. | |
| Risankizumab | Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start14 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073079
- Sponsor's protocol ID
- P25-397
- Acronym
- CROHNOS
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
- ClinicalTrials.gov ID
- NCT07073079
- Acronym / sponsor ID
- CROHNOS / P25-397
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Upadacitinib, Risankizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | – | –Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months. |
| Risankizumab | – | –Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with Crohn's Disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by AbbVie at 25 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caterina Golotta (+39 06 548891, caterina.golotta@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve Corticosteroids (CS) Free Remission (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.