Crohn DiseasePhase 4NCT04835506
Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
A Phase 4 study testing Infliximab in people with Crohn Disease and Ulcerative Colitis, run by Beth Israel Deaconess Medical Center at 25 sites in 2 countries.
Trial summary
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 1 Nov 2021to Sep 2026
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive.
- Diagnosis of IBD prior to screening using standard endoscopic, histologic, or radiologic criteria. Participants with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD or UC. Enrollment of participants with UC will be capped at 49% of the planned study population (maximum 61 participants).
- Moderately to severely active IBD, defined by a total CDAI score between 220 and 450 points for CD or a partial Mayo Score (PMS) > 4 for UC (including a rectal bleeding subscore [RBS] ≥ 1), and at least 1 of the following:
- Elevated CRP (> upper limit of normal)
- Elevated FC (> 250 μg/g)
- SES-CD > 6 (SES-CD > 3 for isolated ileal disease) for CD only and a Mayo endoscopic subscore (MES) ≥ 2 for UC only.
Show all 10Show fewer
- Physician intends to prescribe IFX as part of the usual care of the subject.
- No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol
- Able to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Who cannot join
- Participants with any of the following IBD-related complications:
- Abdominal or pelvic abscess, including perianal
- Presence of stoma, ileal pouch-anal anastomosis, or ostomy
- Isolated perianal disease
- Obstructive disease, such as obstructive stricture
- Short gut syndrome
Show all 19Show fewer
- Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD for CD or PMS, PRO2, or MES for UC)
- Total colectomy.
- History or current diagnosis of ulcerative proctitis (UC extending < 15 cm from the anal verge), acute severe (fulminant) UC, hospitalised IV steroid-refractory UC, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
- Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening.
- Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years.
- Known primary or secondary immunodeficiency.
- PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy.
- Subjects with failure to a prior biologic, defined as PNR or SLR, will be excluded when a maximum of 40% of the planned enrollment (approximately 78 subjects) have failure to prior biologic exposure.
- Concomitant use of oral corticosteroid therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent, unless a tapering schedule is initiated with a plan to be off CS by Week 14
- Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label.
- A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
- Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status.
- Known intolerance or hypersensitivity to IFX or other murine proteins.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Boston Children's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
Atrium Health Center for Digestive Health
Charlotte, North Carolina, 28204
University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Northwestern University
Evanston, Illinois, 60208
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 20500
Yale University School of Medicine
New Haven, Connecticut, 06510
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medical College
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
LifeSpan Brown University
Providence, Rhode Island, 02915
Rockford GI
Rockford, Illinois, 61107
University of Utah
Salt Lake City, Utah, 84132
Canada2 sites
London Health Sciences Centre - Children's Hospital
London
McGill University Health Centre (MUHC) Montreal General Hospital
Montreal
About this study
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.
Read the detailed description
Inflammatory bowel disease (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC) are life-long chronic diseases characterized by transmural inflammation of the intestine. CD and UC are global diseases in the 21st century with increasing incidence in newly industrialized countries. One of the most effective therapies to treat patients with moderate to severe disease is the antitumor necrosis factor (TNF) agent infliximab (IFX) either as monotherapy or as a combination therapy with an immunomodulator (IMM), such as azathioprine or methotrexate (MTX).
Although more effective, combination therapy is associated with more serious adverse events, such as serious opportunistic infections and cancers, as well as potential treatment adherence issues. Consequently, many patients and physicians choose to use IFX alone as safety is often prioritized over efficacy. Unfortunately, up to 30% of patients do not respond to induction therapy, and up to 50% of initial responders lose response over time. It is only if patients lose response that physicians check blood IFX concentrations (i.e., reactive therapeutic drug monitoring [TDM]), or empirically increase IFX dose. Reactive TDM helps to explain and better manage these patients with lack or loss of response to IFX. In many cases, the lack or LOR is due to low drug concentrations with or without development of antibodies to IFX (ATI). Unfortunately, reactive TDM or empiric dose escalation is often too late for patients who do not either respond to IFX induction therapy or lose response during maintenance. This reactive approach results in many patients losing IFX as a therapeutic option.
Preliminary data show that proactive IFX optimization to achieve a threshold drug concentration during maintenance therapy (even if the patient is asymptomatic) compared to empiric dose escalation and/or reactive TDM is associated with better long-term outcomes including longer drug persistence, reduced risk of relapse, and fewer hospitalizations and surgeries. IFX dosing by weight only (i.e., mg/kg) may not be adequate for many patients as interindividual variability in drug clearance and other factors affecting IFX concentrations and PK are often not accounted for. Dosing calculators take into account all of these individual factors and improve the precision of dosing towards better personalized medicine. These systems have already been validated, and personalized dosing has shown clinical benefit in patients with IBD.
This is a randomized, controlled, multicenter, open-label study that plans to enroll 196 participants with inflammatory bowel disease. All eligible participants will be randomly assigned in a 1:1 ratio to receive either IFX monotherapy with proactive TDM or SOC IFX therapy, with or without concomitant IMM therapy, and empiric dose optimization or reactive TDM, at the discretion of the investigator.
- Being tested
- Infliximab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
infliximab
| Study group | Role | What they receive |
|---|---|---|
| proactive infliximab optimization | Experimental | proactive infliximab optimization using a pharmacokinetic dashboard Receives: Drug: Infliximab |
| standard of care infliximab dosing | Experimental | standard of care infliximab dosing Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission
Proportion of subjects with sustained corticosteroid-free (no CS use from Week 14 through 52) clinical remission (CD: CDAI <150 at Weeks 14, 26, 52; UC: PRO2 ≤ 1 with an RBS = 0) and no disease worsening
Measured: 52 weeks
Secondary outcomes (12)
clinical remission
Proportion of subjects in CS-free clinical remission (CD: CDAI < 150; UC: PRO2 ≤ 1 with an RBS = 0) and no use of CS within previous 6 months)
Measured: 52 weeks
deep remission
Proportion of subjects in deep remission (CD: CDAI < 150 and SES-CD ≤ 4, with no individual subscore > 1; UC: PRO2 ≤ 1 with an RBS = 0 and MES ≤ 1)
Measured: 52 weeks
composite biological and endoscopic remission
Proportion of subjects with a composite biological (hs-CRP < 10 mg/L) and endoscopic remission (CD: SES-CD ≤ 4; UC: MES ≤ 1)
Measured: 52 weeks
sustained CS-free clinical remission
Proportion of subjects with sustained CS-free clinical remission (CD: CDAI < 150; UC: PRO2 ≤ 1 with an RBS = 0) and no CS use or need for rescue therapy from Week 14 through Week 52)
Measured: 52 weeks
primary non-responders
Proportion of subjects who are primary nonresponders (≤ 70-point decrease in CDAI score or lack of a ≥ 1-point and 30% reduction from baseline in PRO2 and a ≥ 1-point reduction in RBS or an absolute RBS ≤ 1 for UC and at least one of: hs-CRP ≥10 mg/L, FC > 250 μg/g, or SES-CD > 4 or MES > 1 for UC, or disease worsening prior to Week 14)
Measured: 14 weeks
biological remission
Proportion of subjects with sustained biological remission (hs-CRP <10 mg/L)
Measured: 52 weeks
endoscopic remission
Proportion of subjects with endoscopic remission (SES-CD ≤ 4, with no individual subscore > 1 for CD or MES ≤ 1 for UC)
Measured: 52 weeks
hs-CRP normalization
Proportion of subjects with normalization of hs-CRP (decrease from ≥ 10 at baseline to < 10 mg/L)
Measured: 52 weeks
hs-CRP change from baseline
Hs-CRP change from baseline
Measured: week 14, week 26, and week 52
endoscopic response
Proportion of subjects with an endoscopic response (CD: ≥ 50% decrease from baseline SES-CD score; UC: ≥ 1-point decrease in MES)
Measured: 52 weeks
fecal calprotectin
Proportion of subjects with normalization of fecal calprotectin (decrease from >250 µg/g at baseline to ≤ 250 µg/g)
Measured: 52 weeks
fecal calprotectin change
fecal calprotectin change from baseline
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Nov 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Adam Cheifetz, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835506
- Sponsor's protocol ID
- 2021P000391
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data and trial-level data will be available on reasonable request. This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement
Publications
Papamichael K, Jairath V, Zou G, Cohen B, Ritter T, Sands B, Siegel C, Valentine J, Smith M, Vande Casteele N, Dubinsky M, Cheifetz A. Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial). BMJ Open. 2022 Apr 1;12(4):e057656. doi: 10.1136/bmjopen-2021-057656.
PubMed 35365535
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
- ClinicalTrials.gov ID
- NCT04835506
- Acronym / sponsor ID
- 2021P000391
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Icahn School of Medicine at Mount Sinai
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Apr 2021 (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 OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.
Detailed description
Inflammatory bowel disease (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC) are life-long chronic diseases characterized by transmural inflammation of the intestine. CD and UC are global diseases in the 21st century with increasing incidence in newly industrialized countries. One of the most effective therapies to treat patients with moderate to severe disease is the antitumor necrosis factor (TNF) agent infliximab (IFX) either as monotherapy or as a combination therapy with an immunomodulator (IMM), such as azathioprine or methotrexate (MTX).
Although more effective, combination therapy is associated with more serious adverse events, such as serious opportunistic infections and cancers, as well as potential treatment adherence issues. Consequently, many patients and physicians choose to use IFX alone as safety is often prioritized over efficacy. Unfortunately, up to 30% of patients do not respond to induction therapy, and up to 50% of initial responders lose response over time. It is only if patients lose response that physicians check blood IFX concentrations (i.e., reactive therapeutic drug monitoring [TDM]), or empirically increase IFX dose. Reactive TDM helps to explain and better manage these patients with lack or loss of response to IFX. In many cases, the lack or LOR is due to low drug concentrations with or without development of antibodies to IFX (ATI). Unfortunately, reactive TDM or empiric dose escalation is often too late for patients who do not either respond to IFX induction therapy or lose response during maintenance. This reactive approach results in many patients losing IFX as a therapeutic option.
Preliminary data show that proactive IFX optimization to achieve a threshold drug concentration during maintenance therapy (even if the patient is asymptomatic) compared to empiric dose escalation and/or reactive TDM is associated with better long-term outcomes including longer drug persistence, reduced risk of relapse, and fewer hospitalizations and surgeries. IFX dosing by weight only (i.e., mg/kg) may not be adequate for many patients as interindividual variability in drug clearance and other factors affecting IFX concentrations and PK are often not accounted for. Dosing calculators take into account all of these individual factors and improve the precision of dosing towards better personalized medicine. These systems have already been validated, and personalized dosing has shown clinical benefit in patients with IBD.
This is a randomized, controlled, multicenter, open-label study that plans to enroll 196 participants with inflammatory bowel disease. All eligible participants will be randomly assigned in a 1:1 ratio to receive either IFX monotherapy with proactive TDM or SOC IFX therapy, with or without concomitant IMM therapy, and empiric dose optimization or reactive TDM, at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proactive infliximab optimization | Experimental | Drug: Infliximabproactive infliximab optimization using a pharmacokinetic dashboard |
| standard of care infliximab dosing | Experimental | Drug: Infliximabstandard of care infliximab dosing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive.
- Diagnosis of IBD prior to screening using standard endoscopic, histologic, or radiologic criteria. Participants with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD or UC. Enrollment of participants with UC will be capped at 49% of the planned study population (maximum 61 participants).
- Moderately to severely active IBD, defined by a total CDAI score between 220 and 450 points for CD or a partial Mayo Score (PMS) > 4 for UC (including a rectal bleeding subscore [RBS] ≥ 1), and at least 1 of the following:
- Physician intends to prescribe IFX as part of the usual care of the subject.
- No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol
Key exclusion criteria (19 listed)
- Participants with any of the following IBD-related complications:
- History or current diagnosis of ulcerative proctitis (UC extending < 15 cm from the anal verge), acute severe (fulminant) UC, hospitalised IV steroid-refractory UC, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
- Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening.
- Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years.
- Known primary or secondary immunodeficiency.
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 |
|---|---|---|
| Infliximabinfliximab | Drug | proactive infliximab optimization, standard of care infliximab dosing |
Primary outcome
clinical remission
Time frame: 52 weeks
Proportion of subjects with sustained corticosteroid-free (no CS use from Week 14 through 52) clinical remission (CD: CDAI <150 at Weeks 14, 26, 52; UC: PRO2 ≤ 1 with an RBS = 0) and no disease worsening
12 secondary outcomes
clinical remission
Time frame: 52 weeks
deep remission
Time frame: 52 weeks
composite biological and endoscopic remission
Time frame: 52 weeks
sustained CS-free clinical remission
Time frame: 52 weeks
primary non-responders
Time frame: 14 weeks
biological remission
Time frame: 52 weeks
endoscopic remission
Time frame: 52 weeks
hs-CRP normalization
Time frame: 52 weeks
hs-CRP change from baseline
Time frame: week 14, week 26, and week 52
endoscopic response
Time frame: 52 weeks
fecal calprotectin
Time frame: 52 weeks
fecal calprotectin change
Time frame: 52 weeks
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 5 Mar 2026.
- Derived from this study: PubMed 35365535Papamichael K, Jairath V, Zou G, Cohen B, Ritter T, Sands B, Siegel C, Valentine J, Smith M, Vande Casteele N, Dubinsky M, Cheifetz A. Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial). BMJ Open. 2022 Apr 1;12(4):e057656. doi: 10.1136/bmjopen-2021-057656.
- Individual participant dataSharing planned: Yes. De-identified participant data and trial-level data will be available on reasonable request. This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab in people with Crohn Disease and Ulcerative Colitis, run by Beth Israel Deaconess Medical Center at 25 sites in 2 countries.
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 10 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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 United States, Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
clinical remission (time frame: 52 weeks). 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 NCT04835506, which also lists 1 linked publication.
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 5 Mar 2026.