Crohn DiseaseROLL'YN-USTNCT06997055
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
An observational study of Crohn Disease and Plaque Psoriasis, run by Celltrion HealthCare France at 1 site in France.
Trial summary
ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Plaque Psoriasis
- What is being tested?
- Ustekinumab 45 mg and Ustekinumab 90 mg
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to 31 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 dermatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Crohn's Disease * Plaque Psoriasis
Who may be able to join
- Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis
- Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis
- Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.
- For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study)
- Have an email address.
- Have a mobile phone number.
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- Be able to understand and complete questionnaires in French.
- Not opposed to participating in the study.
- Be affiliated to a French Social Security scheme or be a beneficiary of such a scheme.
Who cannot join
- Patients under guardianship or otherwise deprived of their freedom.
- Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments.
- Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies.
- Contraindication to study products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab
ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.
Read the detailed description
Biotherapies have revolutionized the management of chronic inflammatory diseases in gastroenterology (Crohn's disease and ulcerative colitis), dermatology (e.g. plaque psoriasis and chronic spontaneous urticaria). However, due to their specificity and complexity, these treatments have a high financial cost, which has a significant impact on healthcare systems.
Following the loss of patent protection for these reference biotherapies, biosimilars were developed. These are similar to the reference molecules, but not strictly identical. As a result, to obtain marketing authorization, a biosimilar must demonstrate equivalence to the reference biologic in terms of efficacy and safety in a single indication defined in a Phase I (pharmacokinetic) and Phase III (clinical) study, before being extrapolated to other indications, as applicable.
This study aims to address these subjects for STEQEYMA® (CT-P43), a biosimilar ustekinumab approved by the European Commission on August 22, 2024, through a centralized procedure. STEQEYMA® is indicated for the treatment of moderate to severe forms of Crohn's disease (CD) and plaque psoriasis.
ROLL'YN-UST (CohoRt for the management Of chronic infLammatory diseases in a nationaL observational studY, in patieNts treated by Steqeyma®, an USTekinumab biosimilar - Etude observationnelle de cohorte pour la prise en charge des patients atteints de pathologies inflammatoires chroniques traités par Steqeyma®, un biosimilaire de l'ustekinumab) is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.
- Conditions
- Crohn Disease, Plaque Psoriasis
- Being tested
- Ustekinumab 45 mg, Ustekinumab 90 mg
- Keywords
- Biosimilar, ustekinumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ustekinumab 45 mgDrug
biosimilar
Ustekinumab 90 mgDrug
biosimilar
| Study group | Role | What they receive |
|---|---|---|
| CD group | Switch from ustekinumab originator in patients with Crohn's disease Receives: Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg | |
| Psoriasis Group | Switch from ustekinumab originator in patients with Plaque Psoriasis Receives: Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of remission, 12 months after initiation of biosimilar treatment
Percentage of patients still in clinical remission 12 months after initiation of biosimilar treatment according to the definitions used in the inclusion criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start17 Mar 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltrion HealthCare France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997055
- Sponsor's protocol ID
- CTHC-CTP43-2
- Other IDs
- 2024-A02471-46
- Acronym
- ROLL'YN-UST
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab
- ClinicalTrials.gov ID
- NCT06997055
- Acronym / sponsor ID
- ROLL'YN-UST / CTHC-CTP43-2
- Conditions
- Crohn Disease, Plaque Psoriasis
- Keywords
- Biosimilar, ustekinumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Celltrion HealthCare FranceIndustry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 May 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.
ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.
Detailed description
Biotherapies have revolutionized the management of chronic inflammatory diseases in gastroenterology (Crohn's disease and ulcerative colitis), dermatology (e.g. plaque psoriasis and chronic spontaneous urticaria). However, due to their specificity and complexity, these treatments have a high financial cost, which has a significant impact on healthcare systems.
Following the loss of patent protection for these reference biotherapies, biosimilars were developed. These are similar to the reference molecules, but not strictly identical. As a result, to obtain marketing authorization, a biosimilar must demonstrate equivalence to the reference biologic in terms of efficacy and safety in a single indication defined in a Phase I (pharmacokinetic) and Phase III (clinical) study, before being extrapolated to other indications, as applicable.
This study aims to address these subjects for STEQEYMA® (CT-P43), a biosimilar ustekinumab approved by the European Commission on August 22, 2024, through a centralized procedure. STEQEYMA® is indicated for the treatment of moderate to severe forms of Crohn's disease (CD) and plaque psoriasis.
ROLL'YN-UST (CohoRt for the management Of chronic infLammatory diseases in a nationaL observational studY, in patieNts treated by Steqeyma®, an USTekinumab biosimilar - Etude observationnelle de cohorte pour la prise en charge des patients atteints de pathologies inflammatoires chroniques traités par Steqeyma®, un biosimilaire de l'ustekinumab) is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD group | – | Drug: Ustekinumab 45 mg, Drug: Ustekinumab 90 mgSwitch from ustekinumab originator in patients with Crohn's disease |
| Psoriasis Group | – | Drug: Ustekinumab 45 mg, Drug: Ustekinumab 90 mgSwitch from ustekinumab originator in patients with Plaque Psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult dermatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Crohn's Disease * Plaque Psoriasis
Key inclusion criteria (9 listed)
- Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis
- Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis
- Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.
- For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study)
- Have an email address.
Key exclusion criteria (4 listed)
- Patients under guardianship or otherwise deprived of their freedom.
- Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments.
- Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies.
- Contraindication to study products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ustekinumab 45 mgbiosimilar | Drug | CD group, Psoriasis Group |
| Ustekinumab 90 mgbiosimilar | Drug | CD group, Psoriasis Group |
Primary outcome
Maintenance of remission, 12 months after initiation of biosimilar treatment
Time frame: 12 months
Percentage of patients still in clinical remission 12 months after initiation of biosimilar treatment according to the definitions used in the inclusion criteria.
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 30 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Plaque Psoriasis, run by Celltrion HealthCare France at 1 site in France.
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 9 inclusion and 4 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Salim BENKHALIFA, MD (+33 1 71 25 27 00, etudescliniques_fr@celltrionhc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of remission, 12 months after initiation of biosimilar treatment (time frame: 12 months). 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 30 May 2025.