Ulcerative Colitis (UC)Phase 4NCT07686757
INSIGHT-IBD Pragmatic Study
A Phase 4 study testing Mirikizumab, Anti-TNF agents and anti-integrin antibodies in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by Specialty Networks Research. at 11 sites in United States.
Trial summary
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice. The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Mirikizumab, Anti-TNF agents and anti-integrin antibodies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Aug 2026to Jun 2028
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years at the time of enrollment
- Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
- Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
- No prior exposure to mirikizumab and no contraindications to mirikizumab
- Ability to provide informed consent
- Willingness to comply with study procedures and follow-up requirements
Who cannot join
- Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
- Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
- Participation in an interventional clinical trial within 90 days prior to enrollment
- History of extensive colorectal resection, including:
- Total proctocolectomy (for UC), or
- Surgical removal of two or more intestinal segments (for CD)
- Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites
Texas Digestive Disease Consultants
Cedar Park, Texas, 78613
Texas Digestive Disease Consultants
Fort Worth, Texas, 76104
GI Alliance of Illinois
Glenview, Illinois, 60005
Lake Shore Gastro-Gurnee Research
Gurnee, Illinois, 60031
Digestive Health Associates
Houston, Texas, 77024
Texas Digestive Disease Consultants: Plano
Plano, Texas, 75093
GI Alliance Richmond
Richmond, Virginia, 23229
Gastroenterology Group of Rochester
Rochester, New York, 14618
Texas Digestive Disease Consultants: San Antonio
San Antonio, Texas, 78215
Texas Digestive Disease Consultants: San Marcos
San Marcos, Texas, 78666
Arizona Digestive Health
Sun City, Arizona, 85351
About this study
Official title: INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
Read more
The main questions it aims to answer are:
- Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
- Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
- Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
- Receive either mirikizumab or standard biologic therapy as part of routine clinical care
- Attend follow-up visits at approximately 3, 6, 12, and 18 months
- Have clinical data collected from electronic health records and healthcare utilization sources
- Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
- Undergo routine laboratory tests and clinical assessments as part of standard care
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Being tested
- Mirikizumab, Anti-TNF agents, anti-integrin antibodies, IL-12, IL-23
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
Anti-TNF agentsDrug
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
anti-integrin antibodiesDrug
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
IL-12Drug
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
IL-23Drug
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab Clinical Care Pathway | Active comparator | Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care. Receives: Drug: Mirikizumab |
| Standard Biologic Therapy Clinical Care Pathway | Active comparator | Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists. Receives: Drug: Anti-TNF agents; Drug: anti-integrin antibodies; Drug: IL-12; Drug: IL-23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Requiring an Increase in IBD Disease Management
The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.
Measured: Up to 18 months following initiation of therapy
Secondary outcomes (17)
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores
Change from baseline in disease activity assessed using validated patient-reported outcome measures:
Crohn's Disease Patient-Reported Outcome 2 (CD PRO2), composed of:
Abdominal pain score (range 0-3) Stool frequency (number of bowel movements per day; higher values indicate worse disease activity)
Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores
Change from baseline in disease activity assessed using validated patient-reported outcome measures:
Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of:
Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Total possible combined score range: 0-6, with higher scores indicating worse disease activity
Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.
Measured: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)
Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring system:
Simple Endoscopic Score for Crohn's Disease (SES-CD) (range 0-56), where lower scores indicate less endoscopic disease activity and endoscopic remission is defined as a score ≤2
Endoscopic findings are collected as part of routine clinical care, when available.
Measured: Up to 18 months (as available from routine clinical care)
Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.
Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring systems:
Modified Baron Score (ulcerative colitis) (range 0-4), where lower scores indicate less mucosal inflammation and endoscopic remission is defined as a score of 0 (normal mucosa with no visible inflammation)
Endoscopic findings are collected as part of routine clinical care, when available.
Measured: Up to 18 months (as available from routine clinical care)
Treatment Persistence
Duration of time from treatment initiation to discontinuation of index therapy for any reason, including continued use at pre-specified timepoints.
Measured: Up to 18 months
Proportion of Patients with Dose Escalation
Proportion of patients who discontinue index therapy and/or initiate a subsequent IBD therapy during the study period.
Measured: Up to 18 months
Time to Next Treatment
Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.
Measured: Up to 18 months
Concomitant Medication Use
Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns.
Measured: Baseline through 18 months
Corticosteroid-Free Time
Duration of time patients remain free from corticosteroid use while receiving index therapy.
Measured: Up to 18 months
Healthcare Resource Utilization
Frequency and rate of IBD-related healthcare utilization
Measured: Up to 18 months
Change in Patient-Reported Outcomes Measured by SIBDQ
Change from baseline in patient-reported outcomes assessed using validated instrument:
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (range 10-70), where higher scores indicate better health-related quality of life
Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by UNRS
Change from baseline in patient-reported outcomes assessed using validated instrument:
Bowel Urgency Numeric Rating Scale (UNRS) (range 0-10), where higher scores indicate worse bowel urgency
Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by PROMIS Global Health
Change from baseline in patient-reported outcomes assessed using validated instrument:
PROMIS Global Health (PROMIS-GH) (T-score standardized, mean 50), where higher scores indicate better overall health status
Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by SAA
Change from baseline in patient-reported outcomes assessed using validated instrument:
Sexual Activity Avoidance (SAA), where higher scores indicate greater avoidance of sexual activity
Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.
Measured: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by WPAI:SHP
Change from baseline in patient-reported outcomes assessed using validated instrumens:
Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) (0-100%), where higher percentages indicate greater impairment
Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.
Measured: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.
Proportion of participants achieving clinical remission based on validated patient-reported outcome measures:
Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of:
Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1
These thresholds represent minimal or no symptoms consistent with clinical remission.
Measured: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.
Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission.
Measured: Baseline, 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start12 Aug 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized, parallel-group study in which participating community gastroenterology practices are randomized to either a mirikizumab treatment pathway or a standard biologic therapy pathway. All eligible patients enrolled at a given site receive the treatment assigned to that site. Patients are followed prospectively under routine clinical care without crossover between treatment groups.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Specialty Networks Research.
- Sponsor type
- Research network
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Casey Chapman, MD, Principal investigator, GIANicholas Lazarou, MPH, MBA, Principal investigator, Cardinal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686757
- Sponsor's protocol ID
- 103899
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share Individual Participant Data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
- ClinicalTrials.gov ID
- NCT07686757
- Acronym / sponsor ID
- 103899
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Specialty Networks Research.Research network
- Collaborators
- Eli Lilly and Company
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Jul 2026 (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 goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
- Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
- Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
- Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
- Receive either mirikizumab or standard biologic therapy as part of routine clinical care
- Attend follow-up visits at approximately 3, 6, 12, and 18 months
- Have clinical data collected from electronic health records and healthcare utilization sources
- Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
- Undergo routine laboratory tests and clinical assessments as part of standard care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized, parallel-group study in which participating community gastroenterology practices are randomized to either a mirikizumab treatment pathway or a standard biologic therapy pathway. All eligible patients enrolled at a given site receive the treatment assigned to that site. Patients are followed prospectively under routine clinical care without crossover between treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab Clinical Care Pathway | Active comparator | Drug: MirikizumabParticipants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care. |
| Standard Biologic Therapy Clinical Care Pathway | Active comparator | Drug: Anti-TNF agents, Drug: anti-integrin antibodies, Drug: IL-12, Drug: IL-23Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥21 years at the time of enrollment
- Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
- Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
- No prior exposure to mirikizumab and no contraindications to mirikizumab
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
- Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
- Participation in an interventional clinical trial within 90 days prior to enrollment
- History of extensive colorectal resection, including:
- Total proctocolectomy (for UC), or
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 |
|---|---|---|
| MirikizumabMirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease. | Drug | Mirikizumab Clinical Care Pathway |
| Anti-TNF agentsBiologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. | Drug | Standard Biologic Therapy Clinical Care Pathway |
| anti-integrin antibodiesBiologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. | Drug | Standard Biologic Therapy Clinical Care Pathway |
| IL-12Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. | Drug | Standard Biologic Therapy Clinical Care Pathway |
| IL-23Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. | Drug | Standard Biologic Therapy Clinical Care Pathway |
Primary outcome
Proportion of Patients Requiring an Increase in IBD Disease Management
Time frame: Up to 18 months following initiation of therapy
The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.
17 secondary outcomes
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores
Time frame: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: Up to 18 months (as available from routine clinical care)
Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.
Time frame: Up to 18 months (as available from routine clinical care)
Treatment Persistence
Time frame: Up to 18 months
Proportion of Patients with Dose Escalation
Time frame: Up to 18 months
Time to Next Treatment
Time frame: Up to 18 months
Concomitant Medication Use
Time frame: Baseline through 18 months
Corticosteroid-Free Time
Time frame: Up to 18 months
Healthcare Resource Utilization
Time frame: Up to 18 months
Change in Patient-Reported Outcomes Measured by SIBDQ
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by UNRS
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by PROMIS Global Health
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by SAA
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in Patient-Reported Outcomes Measured by WPAI:SHP
Time frame: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.
Time frame: Baseline, 6 months, 12 months, and 18 months
Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.
Time frame: Baseline, 6 months, 12 months, and 18 months
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 2 Oct 2026.
- Individual participant dataSharing planned: No. This study does not plan to share Individual Participant Data (IPD)
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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.
Casey Chapman, MD principal investigator
GIA
Nicholas Lazarou, MPH, MBA principal investigator
Cardinal Health
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab, Anti-TNF agents and anti-integrin antibodies in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by Specialty Networks Research. at 11 sites in United States.
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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Proportion of Patients Requiring an Increase in IBD Disease Management (time frame: Up to 18 months following initiation of therapy). 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 2 Oct 2026.