Ulcerative Colitis (UC)EMPOWER-IBDNCT06646757
Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
A study testing APP, CBT and HELP in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by University of Pennsylvania at 1 site in United States.
Trial summary
EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- APP, CBT and HELP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 15 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
- Able to consent, complete surveys, and participate in focus groups in English.
Who cannot join
- No/low disability (IBD-DI < 35) on the baseline survey
- Inability or unwillingness to participate in the interventions
- Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
- Limited English proficiency (necessary because some interventions are currently only offered in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Being tested
- APP, CBT, HELP, PEER
- 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.
APPBehavioural
- My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
CBTBehavioural
- "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
HELPBehavioural
- IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
PEERBehavioural
- Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | No resource provision |
| Arm 2 | Experimental | Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: PEER |
| Arm 3 | Experimental | IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Receives: Behavioral: HELP |
| Arm 4 | Experimental | IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: HELP; Behavioral: PEER |
| Arm 5 | Experimental | "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) Receives: Behavioral: CBT |
| Arm 6 | Experimental | "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: CBT; Behavioral: PEER |
| Arm 7 | Experimental | "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Receives: Behavioral: CBT; Behavioral: HELP |
| Arm 8 | Experimental | "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: CBT; Behavioral: HELP; Behavioral: PEER |
| Arm 9 | Experimental | 1) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs Receives: Behavioral: APP |
| Arm 10 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: APP; Behavioral: PEER |
| Arm 11 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Receives: Behavioral: APP; Behavioral: HELP |
| Arm 12 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: APP; Behavioral: HELP; Behavioral: PEER |
| Arm 13 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) Receives: Behavioral: APP; Behavioral: CBT |
| Arm 14 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: APP; Behavioral: CBT; Behavioral: PEER |
| Arm 15 | Experimental | My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Receives: Behavioral: APP; Behavioral: CBT; Behavioral: HELP |
| Arm 16 | Experimental | 1. My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
2. "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
3. IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
4. Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation Receives: Behavioral: APP; Behavioral: CBT; Behavioral: HELP; Behavioral: PEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBD-related disability based on the validated IBD-Disability Index
The study seeks to identify any changes in IBD-related disability pre-post intervention (week 0 and week 12) as measured by the IBD Disability Index (IBD-DI). IBD-related disability is measured by the validated 14-item IBD-disability index (yes-no responses and 1-5 point Likert scales) for limitations across 5 domains of International Classification of Functioning, Health, and Disability. Higher score indicates more disability. Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).
Measured: 12 weeks
Secondary outcomes (1)
Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale
The study seeks to identify any changes in IBD self-efficacy as measured in the 13-item IBD-Self Efficacy Wasson Health Confidence Scale. This is one survey. A higher score indicates more confidence in self-efficacy and health confidence relative to chronic illness. Total score ranges from 0-130
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start14 Aug 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646757
- Sponsor's protocol ID
- 853060
- Acronym
- EMPOWER-IBD
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2024
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
- ClinicalTrials.gov ID
- NCT06646757
- Acronym / sponsor ID
- EMPOWER-IBD / 853060
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 17 Oct 2024 (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.
EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –No resource provision |
| Arm 2 | Experimental | Behavioral: PEERPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 3 | Experimental | Behavioral: HELPIBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost |
| Arm 4 | Experimental | Behavioral: HELP, Behavioral: PEERIBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 5 | Experimental | Behavioral: CBT"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) |
| Arm 6 | Experimental | Behavioral: CBT, Behavioral: PEER"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 7 | Experimental | Behavioral: CBT, Behavioral: HELP"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost |
| Arm 8 | Experimental | Behavioral: CBT, Behavioral: HELP, Behavioral: PEER"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 9 | Experimental | Behavioral: APP1) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs |
| Arm 10 | Experimental | Behavioral: APP, Behavioral: PEERMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 11 | Experimental | Behavioral: APP, Behavioral: HELPMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost |
| Arm 12 | Experimental | Behavioral: APP, Behavioral: HELP, Behavioral: PEERMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 13 | Experimental | Behavioral: APP, Behavioral: CBTMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) |
| Arm 14 | Experimental | Behavioral: APP, Behavioral: CBT, Behavioral: PEERMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
| Arm 15 | Experimental | Behavioral: APP, Behavioral: CBT, Behavioral: HELPMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost |
| Arm 16 | Experimental | Behavioral: APP, Behavioral: CBT, Behavioral: HELP, Behavioral: PEER1. My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs 2. "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) 3. IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost 4. Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
- Able to consent, complete surveys, and participate in focus groups in English.
Key exclusion criteria (4 listed)
- No/low disability (IBD-DI < 35) on the baseline survey
- Inability or unwillingness to participate in the interventions
- Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
- Limited English proficiency (necessary because some interventions are currently only offered in English)
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 |
|---|---|---|
| APP1) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs | Behavioural | Arm 10, Arm 11, Arm 12, Arm 13, Arm 14, Arm 15, Arm 16, Arm 9 |
| CBT2) "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) | Behavioural | Arm 13, Arm 14, Arm 15, Arm 16, Arm 5, Arm 6, Arm 7, Arm 8 |
| HELP3) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost | Behavioural | Arm 11, Arm 12, Arm 15, Arm 16, Arm 3, Arm 4, Arm 7, Arm 8 |
| PEER4) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation | Behavioural | Arm 10, Arm 12, Arm 14, Arm 16, Arm 2, Arm 4, Arm 6, Arm 8 |
Primary outcome
Change in IBD-related disability based on the validated IBD-Disability Index
Time frame: 12 weeks
The study seeks to identify any changes in IBD-related disability pre-post intervention (week 0 and week 12) as measured by the IBD Disability Index (IBD-DI). IBD-related disability is measured by the validated 14-item IBD-disability index (yes-no responses and 1-5 point Likert scales) for limitations across 5 domains of International Classification of Functioning, Health, and Disability. Higher score indicates more disability. Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).
1 secondary outcome
Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP, CBT and HELP in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by University of Pennsylvania at 1 site 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 2 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: finished, as of the sponsor's last update on 9 Jan 2026. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in IBD-related disability based on the validated IBD-Disability Index (time frame: 12 weeks). 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 9 Jan 2026.