Crohn's Disease · Ulcerative Colitis
Long-term Vedolizumab Safety Study in Children With Ulcerative Colitis or Crohn’s
This extension study is collecting long-term safety information about intravenous vedolizumab in children with ulcerative colitis or Crohn’s disease who previously participated in one of two parent studies.
Registry title: A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
8 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years and older
- Treatment
- Vedolizumab IV or No Intervention
- Design
- Non Randomized
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
What long-term safety events occur among children with ulcerative colitis or Crohn’s disease who continue intravenous vedolizumab or enter long-term observation after a parent study?
Participant snapshot
Who the study is looking for
- The study is looking for people with ulcerative colitis or Crohn’s disease.
- The registry reports a minimum age of 2 years and describes the study population as pediatric.
- Everyone must have participated in parent study MLN0002-3024 or MLN0002-3025.
- The treatment cohort requires a specified corticosteroid-free clinical response at Week 54; the observational cohort has different parent-study requirements.
Participation overview
What participation may involve
Participation differs by cohort. The treatment cohort receives intravenous vedolizumab every 8 weeks for up to approximately 5 years, while the observational cohort has scheduled safety follow-up visits for approximately 2 years without continued study treatment. What participation may involve: - Treatment-cohort participants receive their parent-study vedolizumab dose by intravenous infusion once every 8 weeks. - The treatment cohort is monitored for adverse events and major inflammatory bowel disease-related events such as hospitalizations, surgeries, and procedures. - Treatment-cohort participants who were ages 9 to 17 at their first parent-study dose complete IMPACT-III quality-of-life assessments every 24 weeks. - Observational-cohort participants attend assessments at Day 1 and Weeks 8, 34, 60, and 86 for specified safety events, growth, and pubertal development. - Treatment-cohort participants complete a final safety or end-of-study visit 18 weeks after their last study-drug dose. Treatment-cohort participation may continue for up to approximately 5 years, subject to earlier withdrawal, pediatric commercial availability, another access program, or sponsor closure. Observational-cohort participation lasts up to approximately 2 years. Vedolizumab is given every 8 weeks in the treatment cohort, with a final safety visit 18 weeks after the last dose. The observational cohort has visits at Day 1 and Weeks 8, 34, 60, and 86.
Study interventions
What participants may receive or do
- Vedolizumab IV: Participants in the treatment cohort receive vedolizumab through an intravenous infusion once every 8 weeks. The dose is based on weight and continues the blinded dose received in the parent study.
- No Intervention: Participants in the observational cohort do not receive continued vedolizumab through this study and instead attend follow-up assessments for specified safety events, growth, and pubertal development.
Study design
How the comparison works
This Phase 3, non-randomized extension study has parallel treatment and observational cohorts. Treatment-cohort participants continue intravenous vedolizumab, while observational-cohort participants receive no study intervention. Participants are not randomly assigned in this extension study; cohort placement depends on parent-study participation and the extension-study criteria. The registry lists this extension as having no masking, but the treatment dose inherited from the parent study remains blinded until that parent study is unblinded. The observational cohort receives no study intervention, but the registry does not describe it as a randomized control group. No placebo intervention or placebo arm is listed for this extension study.
Reported activities
Procedures and tests
- Intravenous vedolizumab infusion once every 8 weeks for treatment-cohort participants.
- Monitoring and recording of adverse events in the treatment cohort.
- Monitoring for serious infections, malignancies, progressive multifocal leukoencephalopathy, growth and pubertal-development concerns, and bowel surgery in the observational cohort.
- Assessment of inflammatory bowel disease-related hospitalizations, surgeries, and procedures in the treatment cohort.
- IMPACT-III questionnaires assessing bowel and systemic symptoms, social functioning, body image, treatment experiences, and emotional functioning for the specified 9-to-17-year-old subgroup.
- Screening may include confirmation of the Week 54 corticosteroid-free clinical response and steroid-taper timing required for the treatment cohort.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Treatment-cohort participants must have completed parent study MLN0002-3024 or MLN0002-3025 and met the specified Week 54 corticosteroid-free clinical-response requirements.
- If steroids applied, treatment-cohort participants must have tapered off them at least 12 weeks before the parent study’s Week 54 visit.
- Sexually active male participants with a female partner who could become pregnant must agree to the specified contraception measures during the study and for 18 weeks after the last dose.
- Female participants who could become pregnant and are sexually active with a nonsterilized male partner must agree to highly effective contraception during the study and for 18 weeks after the last dose.
- The observational cohort requires at least one vedolizumab dose in a parent study followed by early termination, or completion of the parent study’s Week 54 visit without eligibility for this study’s treatment cohort.
- The registry lists a minimum age of 2 years.
Possible reasons someone may not be able to join
- For the treatment cohort, a current or expected need for major ulcerative colitis or Crohn’s disease surgery, such as bowel resection, is an exclusion.
- For the treatment cohort, a new unstable or uncontrolled medical disorder may exclude someone if the investigator believes it could affect results or participant safety.
- Other serious health conditions that would limit the ability to complete the study exclude someone from the treatment cohort.
- Someone who cannot complete all study assessments is excluded from the treatment cohort.
- Hypersensitivity or allergy to any ingredient used in the vedolizumab formulation excludes someone from the treatment cohort.
- Pregnant or lactating participants are excluded from the treatment cohort.
Important unknowns
What the record does not make clear
- The record gives the treatment infusion frequency and final safety-visit timing but does not provide a complete schedule of all treatment-cohort visits and assessments.
- The record does not state which ulcerative colitis or Crohn’s disease treatments may continue alongside study participation.
- A steroid-taper requirement is reported for the treatment cohort, but washout or timing rules for other medicines are not described.
- The record does not explain what treatment is available if ulcerative colitis or Crohn’s disease worsens during the study.
- The record does not state whether endoscopy is required for this extension study.
- The record does not identify which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not report reimbursement or support for travel, lodging, meals, or parking.
- The record does not state whether any follow-up assessments may occur remotely or through a local clinician.
- Treatment may stop when pediatric vedolizumab becomes commercially available or another access program becomes available, but the record does not promise access after study participation ends.
- The study is listed as recruiting overall, but individual locations have recruiting, not-yet-recruiting, withdrawn, or terminated statuses, and the record does not show which cohorts each active site accepts.
Before contacting the site
Questions for the study team
- Which cohort is open at the nearest site, and what parent-study history is required there?
- What is the complete visit schedule for the treatment cohort, including assessments performed between infusions?
- Which current medicines may continue, and are there stopping or timing rules beyond the reported steroid taper?
- What happens if ulcerative colitis or Crohn’s disease worsens, including which rescue treatments are permitted?
- Are colonoscopy, sigmoidoscopy, blood draws, imaging, or other procedures required, and how often?
- Which study-related costs are covered, and are compensation or travel support available?
- Can any follow-up assessments be completed remotely or through the participant’s local care team?
- What options exist for continued vedolizumab access after study treatment ends?
Before changing care
Questions for your gastroenterologist
- How stable is the child’s ulcerative colitis or Crohn’s disease now, and what signs would suggest that continuing the current plan is not appropriate?
- Would any current medicines need to change for this study, and what clinical risks could interruption or adjustment create?
- What approved treatment alternatives are available, and how do their expected burdens and uncertainties compare with this extension study?
- Which of the study’s monitored safety events are most relevant to the child’s medical history and current treatment?
- How should the gastroenterology team and research team coordinate routine care, laboratory monitoring, worsening symptoms, and urgent treatment decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 \[participants with UC\] and MLN0002-3025 \[participants with CD\], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort. Treatment Cohort: The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD. Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups: * Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose) * Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose) * Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) * Participants \>15 to \<30 kg, Vedolizumab 100 mg (Low dose) * Participants ≥30 kg, Vedolizumab 300 mg (High dose) * Participants ≥30 kg, Vedolizumab 150 mg (Low dose) Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study. The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug. Observational Cohort: Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV. The overall time to participate in the Observational Cohort is up to approximately 2 years.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- MLN0002-3029
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Experimental
Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Experimental
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Experimental
Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Experimental
Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Experimental
Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg
Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.
Interventions: Drug: Vedolizumab IV
Other
Observational Cohort: Early Terminated Participants From Parent Studies
Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.
Interventions: Other: No Intervention
Interventions
Drug
Vedolizumab IV
Vedolizumab IV infusion
Other
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Eligibility
2 Years and older
All
Not accepted
Inclusion criteria (4)
- The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.Registry-derived · unreviewed
- A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.Registry-derived · unreviewed
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.Registry-derived · unreviewed
- 1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.Registry-derived · unreviewed
Exclusion criteria (6)
- The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.Registry-derived · unreviewed
- The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.Registry-derived · unreviewed
- The participant has other serious comorbidities that will limit their ability to complete the study.Registry-derived · unreviewed
- The participant is unable to comply with all study assessments.Registry-derived · unreviewed
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.Registry-derived · unreviewed
- The participant is lactating or pregnant.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)
Time frame: From first dose of study drug up to approximately 5 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug.
Primary outcome
Observational Cohort: Number of Participants With Prespecified Safety Events
Time frame: Up to approximately 2 years
Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.
Secondary outcome
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Time frame: Up to approximately 5 years
Major IBD-related events include hospitalizations, surgeries, and procedures in pediatric participants with UC or CD.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The total score is an average of all item scores. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Bowel Symptom Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The bowel symptom subscale score ranges from 1 to 35, with higher scores indicating lesser bowel symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Systemic Symptom Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The Systemic symptom subscale score ranges from 1 to 15, with higher scores indicating lesser systemic symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Social Functioning Subscale is a self-reported measure with 12 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The social functioning subscale score ranges from 1 to 60, with higher scores indicating better social functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Body Image Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The body image subscale score ranges from 1 to 15, with higher scores indicating better body image. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Treatment/Intervention Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The treatment/intervention subscale score ranges from 1 to 15, with higher scores indicating ease of administration of treatment/interventions. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Secondary outcome
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
The IMPACT-III Emotional Functioning Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The emotional functioning subscale score ranges from 1 to 35, with higher scores indicating better emotional functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Recruiting locations in the United States
University of South Alabama (USA) Physicians Group
Not Yet RecruitingMobile, Alabama, 36604, United States
Site Contact
David Gremse
Phoenix Childrens Hospital - Thomas Rd - PIN
RecruitingPhoenix, Arizona, 85016, United States
Site Contact
Ashish Patel
Rady Children's Hospital - San Diego - PIN
Not Yet RecruitingSan Diego, California, 92123, United States
Site Contact
Jeannie Huang
Childrens Center For Digestive Healthcare
Not Yet RecruitingAtlanta, Georgia, 30342, United States
Site Contact
Benjamin Gold
Advocate Children's Hospital - Park Ridge - PIN
RecruitingPark Ridge, Illinois, 60068, United States
Site Contact
Kiranmai Gorla
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Not Yet RecruitingCleveland, Ohio, 44106, United States
Site Contact
Thomas Sferra
Texas Children's Hospital - Baylor - PIN
Not Yet RecruitingHouston, Texas, 77030, United States
Site Contact
Faith Ihekweazu
Carilion Children's Tanglewood Center
RecruitingRoanoke, Virginia, 24018, United States
Site Contact
Monica Garin-Laflam
This study also lists 76 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jul 5, 2022
- Primary completion
- Feb 7, 2033
- Overall completion
- Feb 7, 2033
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.