Colitis, UlcerativeNCT05456412
JAK Inhibition in Ulcerative Colitis
A study testing JAK inhibitor treatment in people with Colitis, Ulcerative, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- JAK inhibitor treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Dec 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Age Ulcerative colitis active disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Philip Voorneveld, MD, PhD, +31715296370, p.w.voorneveld@lumc.nl
About this study
Official title: Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis
The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.
- Conditions
- Colitis, Ulcerative
- Being tested
- JAK inhibitor treatment
- Keywords
- Janus Kinase Inhibitors
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAK inhibitor treatmentOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Treatment JAK inhibitor | Experimental | Clinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken. Receives: Other: JAK inhibitor treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-omics analyses of changes observed after JAK inhibition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start20 Dec 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV
- Responsible party
- Principal investigator, Andrea E. van der Meulen - de Jong, MD, PhD, Leiden University Medical Center
- Investigators
- Andrea van der Meulen, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456412
- Sponsor's protocol ID
- 81808
- Status last verified
- Dec 2022
- First submitted
- 11 Jul 2022
- Last updated
- 22 Dec 2022
- 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 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05456412
- Acronym / sponsor ID
- 81808
- Conditions
- Colitis, Ulcerative
- Keywords
- Janus Kinase Inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Lakefront Biotherapeutics NV
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Jul 2022 (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.
The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
| Arm | Type | Receives |
|---|---|---|
| Treatment JAK inhibitor | Experimental | Other: JAK inhibitor treatmentClinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| JAK inhibitor treatmentStandard care | Other | Treatment JAK inhibitor |
Primary outcome
Multi-omics analyses of changes observed after JAK inhibition
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- 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. This study is not recruiting at the moment.
Andrea van der Meulen, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JAK inhibitor treatment in people with Colitis, Ulcerative, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Dec 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip W Voorneveld, MD, PhD (+31715296370, p.w.voorneveld@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-omics analyses of changes observed after JAK inhibition (time frame: 1 year). 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 22 Dec 2022.