Ulcerative ColitisPROPHETICNCT04576000
Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Alimentiv Inc. at 1 site in Netherlands.
Trial summary
This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Janus Kinase Inhibitor
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Aug 2020to 2 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve subjects with moderately to severely active Ulcerative Colitis who will receive Janus Kinase inhibitor for at least 8 weeks, followed by Janus Kinase inhibitor maintenance therapy for an additional 8 weeks.
Who may be able to join
- 1.18 years of age or older.
- 2.Male or nonpregnant, nonlactating females.
- 3.Diagnosis of Ulcerative Colitis for at least 3 months prior to screening.
- 4.Moderately to severely active Ulcerative Colitis (total Mayo Clinic Score ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending > 15 cm from the anal verge.
- 5.Physician plans to administer Janus Kinase inhibitor for at least 8 weeks of induction therapy as part of Standard of Care (SOC).
- 6.Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.
- 7.Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.
- 8.Written informed consent must be obtained and documented.
Who cannot join
- Diagnosis of Crohn's disease or indeterminate colitis.
- An active, serious infection, including localized infections.
- Concomitant administration of biological therapies for Ulcerative Colitis or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting Janus Kinase inhibitor, in keeping with routine clinical practice.
- Hematology laboratory (e.g., absolute lymphocyte count, absolute neutrophil count, and hemoglobin that contraindicate the product label.
- Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- Serious underlying disease other than Ulcerative Colitis that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam Medical Center, IBD Center
Amsterdam, North Halland, 1105 AZ
About this study
Official title: PhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis (PROPHETIC)
This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating Janus Kinase inhibitor therapy according to standard of care. This study consists of:
- Part 1: 8 or 10 week induction therapy followed by an 8-week maintenance therapy
- Part 2: Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of Janus Kinase inhibitor therapy (whichever is first)
- Conditions
- Ulcerative Colitis
- Being tested
- Janus Kinase Inhibitor
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janus Kinase InhibitorDrug
Janus Kinase inhibitor induction therapy will be administered according to Standard Of Care (SOC)
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Group | Eligible patients will include those who will be prescribed Janus Kinase inhibitor as part of their routine medical care. Receives: Drug: Janus Kinase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify predictive fecal biomarkers that are associated with a change from baseline in UC-100 score
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 is calculated by summing the weighted Mayo Clinic Score (MCS) stool frequency and endoscopy subscores, and the Robarts Histopathology Index (RHI) score as follows: UC-100 Score = 1 + (16 X stool frequency) + (6 X endoscopic subscore) + (RHI score). The total UC-100 score ranges from 1 to 100, with higher scores representing more severe disease activity.
Measured: 8 or 10 weeks; 24 weeks
Identify predictive blood biomarkers that are associated with a change from baseline in UC-100 score
Measured: 8 or 10 weeks; 24 weeks
Identify predictive tissue biomarkers that are associated with a change from baseline in UC-100 score
Measured: 8 or 10 weeks; 24 weeks
Secondary outcomes (20)
Identify pharmacodynamic fecal biomarkers that are associated with a change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify pharmacodynamic blood biomarkers that are associated with a change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify pharmacodynamic tissue biomarkers that are associated with a change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify a fecal biomarker signature as a surrogate measure for change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify a blood biomarker signature as a surrogate measure for change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify a tissue biomarker signature as a surrogate measure for change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Identify whether colonic tissue pSTAT at week 8 and/or 24 correlates with change from baseline in UC-100 score
Measured: 8 or 10 weeks, 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in stool samples.
Measured: 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in serum samples.
Measured: 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in tissue samples.
Measured: 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitor between stool samples following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitor between serum samples following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitors between tissue samples following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in stool samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in serum samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in tissue samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Measured: 8 or 10 weeks, 24 weeks
Develop an exposure-response model of Janus Kinase inhibitors to characterize the relationships between local and systemic drug exposure and clinical, endoscopic, histologic, or biologic response to therapy.
Measured: 24 weeks
Identify potential demographic and disease factors affecting the most relevant JAKi exposure-response relationships and determine target threshold of systemic exposure associated with relevant clinical, endoscopic, histologic, and/or biologic outcomes.
Measured: 8 or 10 weeks, 24 weeks
Evaluate long-term hospitalization rates, surgery rates, and corticosteroid use after initiation of Janus Kinase inhibitor therapy and identify baseline or early biomarker signatures associated with these long-term healthcare resource use outcomes
Measured: 2 years
Measure adverse drug reactions, clinical, endoscopic, and histologic response and remission rates to Janus Kinase inhibitors in a "real-world" population
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start25 Aug 2020
- Primary completion15 Dec 2020
- Study completion2 Dec 2021
Why it stopped: Not able to meet recruitment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Alimentiv Translational Research Consortium
- Responsible party
- Sponsor
- Investigators
- Vipul Jairath, MD, PhD, Principal investigator, Alimentiv Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576000
- Sponsor's protocol ID
- RP1907
- Acronym
- PROPHETIC
- Status last verified
- Dec 2021
- First submitted
- 17 Sep 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, D'Haens GR, Sandborn WJ, Feagan BG. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):63-70. doi: 10.1016/S2468-1253(18)30306-6. Epub 2018 Oct 18.
PubMed 30343116Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Shackelton LM, Walker CW, Nelson S, Vandervoort MK, Frisbie V, Samaan MA, Jairath V, Driman DK, Geboes K, Valasek MA, Pai RK, Lauwers GY, Riddell R, Stitt LW, Levesque BG. Development and validation of a histological index for UC. Gut. 2017 Jan;66(1):50-58. doi: 10.1136/gutjnl-2015-310393. Epub 2015 Oct 16.
PubMed 26475633Scherl EJ, Pruitt R, Gordon GL, Lamet M, Shaw A, Huang S, Mareya S, Forbes WP. Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study. Am J Gastroenterol. 2009 Jun;104(6):1452-9. doi: 10.1038/ajg.2009.83. Epub 2009 Apr 21.
PubMed 19491859Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19.
PubMed 32203403
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis (PROPHETIC)
- ClinicalTrials.gov ID
- NCT04576000
- Acronym / sponsor ID
- PROPHETIC / RP1907
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not able to meet recruitment targets
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Collaborators
- Alimentiv Translational Research Consortium
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 5 Oct 2020 (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.
This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating Janus Kinase inhibitor therapy according to standard of care. This study consists of:
- Part 1: 8 or 10 week induction therapy followed by an 8-week maintenance therapy
- Part 2: Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of Janus Kinase inhibitor therapy (whichever is first)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Group | – | Drug: Janus Kinase InhibitorEligible patients will include those who will be prescribed Janus Kinase inhibitor as part of their routine medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve subjects with moderately to severely active Ulcerative Colitis who will receive Janus Kinase inhibitor for at least 8 weeks, followed by Janus Kinase inhibitor maintenance therapy for an additional 8 weeks.
Key inclusion criteria (8 listed)
- 1.18 years of age or older.
- 2.Male or nonpregnant, nonlactating females.
- 3.Diagnosis of Ulcerative Colitis for at least 3 months prior to screening.
- 4.Moderately to severely active Ulcerative Colitis (total Mayo Clinic Score ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending > 15 cm from the anal verge.
- 5.Physician plans to administer Janus Kinase inhibitor for at least 8 weeks of induction therapy as part of Standard of Care (SOC).
Key exclusion criteria (6 listed)
- Diagnosis of Crohn's disease or indeterminate colitis.
- An active, serious infection, including localized infections.
- Concomitant administration of biological therapies for Ulcerative Colitis or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting Janus Kinase inhibitor, in keeping with routine clinical practice.
- Hematology laboratory (e.g., absolute lymphocyte count, absolute neutrophil count, and hemoglobin that contraindicate the product label.
- Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
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 |
|---|---|---|
| Janus Kinase InhibitorJanus Kinase inhibitor induction therapy will be administered according to Standard Of Care (SOC) | Drug | Open-Label Group |
Primary outcome
Identify predictive fecal biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks; 24 weeks
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 is calculated by summing the weighted Mayo Clinic Score (MCS) stool frequency and endoscopy subscores, and the Robarts Histopathology Index (RHI) score as follows: UC-100 Score = 1 + (16 X stool frequency) + (6 X endoscopic subscore) + (RHI score). The total UC-100 score ranges from 1 to 100, with higher scores representing more severe disease activity.
Identify predictive blood biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks; 24 weeks
Identify predictive tissue biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks; 24 weeks
20 secondary outcomes
Identify pharmacodynamic fecal biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify pharmacodynamic blood biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify pharmacodynamic tissue biomarkers that are associated with a change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify a fecal biomarker signature as a surrogate measure for change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify a blood biomarker signature as a surrogate measure for change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify a tissue biomarker signature as a surrogate measure for change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Identify whether colonic tissue pSTAT at week 8 and/or 24 correlates with change from baseline in UC-100 score
Time frame: 8 or 10 weeks, 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in stool samples.
Time frame: 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in serum samples.
Time frame: 24 weeks
Determine the time-concentration profile of Janus Kinase inhibitor at steady state in tissue samples.
Time frame: 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitor between stool samples following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitor between serum samples following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Evaluate correlation of exposure of Janus Kinase inhibitors between tissue samples following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in stool samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in serum samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Explore the exposure-response relationship of Janus Kinase inhibitors with exposure measured in tissue samples and response defined as tissue PD biomarkers following SOC induction therapy and at Week 24.
Time frame: 8 or 10 weeks, 24 weeks
Develop an exposure-response model of Janus Kinase inhibitors to characterize the relationships between local and systemic drug exposure and clinical, endoscopic, histologic, or biologic response to therapy.
Time frame: 24 weeks
Identify potential demographic and disease factors affecting the most relevant JAKi exposure-response relationships and determine target threshold of systemic exposure associated with relevant clinical, endoscopic, histologic, and/or biologic outcomes.
Time frame: 8 or 10 weeks, 24 weeks
Evaluate long-term hospitalization rates, surgery rates, and corticosteroid use after initiation of Janus Kinase inhibitor therapy and identify baseline or early biomarker signatures associated with these long-term healthcare resource use outcomes
Time frame: 2 years
Measure adverse drug reactions, clinical, endoscopic, and histologic response and remission rates to Janus Kinase inhibitors in a "real-world" population
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Not able to meet recruitment targets). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 30343116Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, D'Haens GR, Sandborn WJ, Feagan BG. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):63-70. doi: 10.1016/S2468-1253(18)30306-6. Epub 2018 Oct 18.
- Background: PubMed 26475633Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Shackelton LM, Walker CW, Nelson S, Vandervoort MK, Frisbie V, Samaan MA, Jairath V, Driman DK, Geboes K, Valasek MA, Pai RK, Lauwers GY, Riddell R, Stitt LW, Levesque BG. Development and validation of a histological index for UC. Gut. 2017 Jan;66(1):50-58. doi: 10.1136/gutjnl-2015-310393. Epub 2015 Oct 16.
- Background: PubMed 19491859Scherl EJ, Pruitt R, Gordon GL, Lamet M, Shaw A, Huang S, Mareya S, Forbes WP. Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study. Am J Gastroenterol. 2009 Jun;104(6):1452-9. doi: 10.1038/ajg.2009.83. Epub 2009 Apr 21.
- Background: PubMed 32203403Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19.
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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.
Vipul Jairath, MD, PhD principal investigator
Alimentiv Inc.
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 Ulcerative Colitis, run by Alimentiv Inc. 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?
The sponsor lists 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Jan 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?
The study was stopped early (reason given: Not able to meet recruitment targets). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify predictive fecal biomarkers that are associated with a change from baseline in UC-100 score (time frame: 8 or 10 weeks; 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04576000, which also lists 4 linked publications.
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 4 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.