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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004300-34 | EudraCT Number | ||
| jRCT2071210030 | Registry Identifier | jRCT | |
| 2023-509018-12-00 | EU Trial (CTIS) Number |
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Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for UC including immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists (eg, infliximab, adalimumab).
The study will enroll approximately 120 patients.
During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline:
At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and weight. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows:
The dose will remain blinded to the participant and study doctor and staff during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance period.
This multi-center trial will be conducted worldwide. After the Week 54 visit, participants who are younger than 18 years may be eligible to continue receiving vedolizumab in extension study MLN0002-3029 (NCT05442567). Participants who do not maintain corticosteroid-free clinical response at Week 54 or who discontinue study drug at any time during the induction or maintenance periods of this study will undergo an end of study (EOS) or early termination (ET) visit, as well as a safety visit 18 weeks after the last dose of vedolizumab, in addition these participants would enter study MLN0002-3029 for an observational long-term follow-up (LTFU) period of 2 years after the last dose of study drug in the current study. During the LTFU period, data will be collected either by clinic visit OR, if site attendance is not feasible, by phone call every 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Period: Participants ≥30 kg, Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm. |
|
| Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg | Experimental | Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg are included in this arm. |
|
| Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg | Experimental | Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm. |
|
| Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. |
|
| Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score | Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy). Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | At Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 14 Based on Modified Mayo Score | Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
Has previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or Abrilumab (AMG 181), or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
Has active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
Has received any live vaccinations within 30 days prior to first dose of study drug.
Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
Participants with a current diagnosis of indeterminate colitis.
Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.
Participant with active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening period that is positive, defined as:
Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA). Note: Subjects who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]).
The participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
Has positive stool studies for ova and/or parasites or stool culture at screening visit.
Has positive Clostridioides difficile (C difficile) stool test at screening visit.
Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital -1919 E Thompson Rd | Phoenix | Arizona | 85016-7710 | United States | ||
| Rady Childrens Hospital San Diego - PIN |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 121 participants with ulcerative colitis (UC) were enrolled. Study has two periods: a 14-week induction phase and a 40-week maintenance phase. Participants who achieved a clinical response at Week 14 were stratified by previous exposure/failure to tumor necrosis factor -alpha (TNF-α) or naive TNF-α antagonist therapy and by weight group (greater than or equal to [>=]30kg; less than [>]15 kg to <30 kg; 10 kg to 15 kg) were randomized to receive vedolizumab in maintenance period.
The study was conducted across 43 investigative sites in the United States, Asia/Australia, Europe, and Israel from 19 October 2021 to 1 July 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants 10 to 15 kg: Vedolizumab 150 mg | Participants with UC who had a baseline weight of 10 to 15 kilograms (kg) received a dose of vedolizumab 150 milligrams (mg), as an intravenous (IV) infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously every 8 weeks (Q8W) from Week 14 through Week 46. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Induction (up to 14 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2025 | Feb 25, 2026 |
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Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. |
|
| Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg | Experimental | Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. |
|
| Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg | Experimental | Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg. |
|
| Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg | Experimental | Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg. |
|
| Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg | Experimental | Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg. |
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| At Week 14 |
| Percentage of Participants With Sustained Clinical Remission at Week 54 Based on Modified Mayo Score | Participants who had clinical remission at Week 14 were analyzed for sustained clinical remission at Week 54. Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | At Week 54 |
| Percentage of Participants With Sustained Endoscopic Remission at Week 54 | Participants who had endoscopic remission at Week 14 were analyzed for sustained endoscopic remission at Week 54. Mayo endoscopic sub score (MES) was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | At Week 54 |
| Percentage of Participants With Endoscopic Response at Week 14 | Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | At Week 14 |
| Percentage of Participants With Endoscopic Response at Week 54 | Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | At Week 54 |
| Percentage of Participants With Corticosteroid-free Clinical Remission at Week 54 | Corticosteroid-free clinical remission based on the modified Mayo score was defined as when a participant meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to and at Week 54 and without presence of any intercurrent event. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | At Week 54 |
| Percentage of Participants With Clinical Remission at Week 54 Based on Complete Mayo Score | Clinical remission based on complete Mayo score was a score (inclusive of physician global assessment [PGA]) of <=2 points with no individual sub score >1 and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease. | At Week 54 |
| Serum Trough Concentrations of Vedolizumab Over Time | Serum trough concentration of vedolizumab was reported. | Predose at Week 14 and post dose at Week 54 |
| Percentage of Participants With Positive Anti-vedolizumab Antibodies (AVA) | AVA positive was defined as a confirmed AVA positive result. | Up to Week 54 |
| Percentage of Participants With Positive Neutralizing AVA | Positive Neutralizing AVA was defined as a positive result in the neutralizing AVA assay at any visit. | Up to Week 54 |
| Percentage of Participants With Sustained Clinical Response at Week 54 Based on Complete Mayo Score | Participants who had clinical response at Week 14 were analyzed for sustained clinical response at Week 54. Sustained refers to meeting the specific endpoint criteria at both Week 14 and Week 54. Sustained clinical response is defined as meeting the following criteria at both Week 14 and Week 54: reduction in complete Mayo score of >=3 points and >=30% from baseline with an accompanying decrease in rectal bleeding sub score of >=1 point or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease. | At Week 54 |
| Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score | Clinical response was where a participant achieved clinical response if they had a reduction of >=2 points and >=25% from the baseline partial Mayo score, including a >=1 point decrease in the Mayo stool frequency sub score and a >=1 point reduction in the rectal bleeding sub score or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score | Clinical remission based on partial Mayo score was defined as a partial Mayo score of <=2 points and no individual sub score >1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI) | A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug through Week 54 for participants entering the extension study or the final safety visit 18 weeks after their last dose of study drug for those who do not enter the extension study or those who early terminate. A TESAE was defined as an undesirable event that was not present prior to medical treatment or an already present event that worsened either in intensity or frequency following the first dose of study drug, that occurred from the first dose of study drug to the day of last dose of study drug + 126 days. AESI was defined as an AE (serious or nonserious) of medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. AESIs include infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]). | From first dose of study drug up to end of follow up (up to 3.7 years) |
| Change From Baseline in Weight | Change from baseline in weight was reported. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Change From Baseline in Weight Z-score | Change from baseline in weight Z-score was reported. Weight z-score expresses how an individual's measured weight compares to the expected weight of a reference population of the same age and sex, standardized using population growth charts. It represents the number of standard deviations (SDs) an individual's weight is above or below the mean of the reference population. Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Change From Baseline in Height | Change from baseline in height was reported. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Change From Baseline in Linear Growth Z-score | Change from baseline in linear growth Z-score were reported. Linear growth Z-score is a standardized measure that describes how far a measured height deviates from the median height of a reference population of the same age and sex based on established growth charts. It is expressed in units of standard deviations (SD). Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean. | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| Number of Participants With Change From Baseline in Tanner Stage at Week 54 | Tanner stages are used to evaluate growth parameters. They are standardized for age, sex, and pubertal development, with Stage 1 representing the prepubertal stage and Stage 5 representing the fully mature adult stage. It measures Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The data reported shows shifts in participants' Tanner stages from baseline to Week 54. | At Week 54 |
| San Diego |
| California |
| 92123 |
| United States |
| Childrens Center For Digestive Healthcare | Atlanta | Georgia | 30318-4833 | United States |
| Advocate Children's Hospital Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| MNGI Digestive Health PA-Plymouth | Minneapolis | Minnesota | 55413 | United States |
| Mayo Clinic - PIN | Rochester | Minnesota | 55905-0001 | United States |
| Goryeb Children's Hospital | Morristown | New Jersey | 07960-6136 | United States |
| UPMC Children's Hospital of Pittsburgh-120 Lytton Ave | Pittsburgh | Pennsylvania | 15224-1334 | United States |
| Texas Childrens Hospital West Campus | Houston | Texas | 77030-2358 | United States |
| Carilion Children's Tanglewood Center | Roanoke | Virginia | 24013-2253 | United States |
| Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Queensland Childrens Hospital | South Brisbane | Queensland | 4101 | Australia |
| Monash Health, Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Royal Children's Hospital Melbourne - PIN | Parkville | Victoria | 3052 | Australia |
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Universitair Ziekenhuis Brussel - PIN | Jette | Brussels Capital | 1090 | Belgium |
| Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg | Leuven | Vlaams Brabant | 3000 | Belgium |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2S2 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Beijing Children's Hospital, Capital Medical University - PIN | Beijing | Beijing Municipality | 100045 | China |
| Henan Children's Hospital Zhengzhou Children's Hospital | Zhengzhou | Henan | 450000 | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| The Children's Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Klinika Za Djecje Bolesti Zagreb | Zagreb | City of Zagreb | 10000 | Croatia |
| Children's Hospital "Agia Sofia" | Athens | Attica | 115 27 | Greece |
| Attikon University General Hospital | Chaïdári | Attica | 124 62 | Greece |
| Ippokratio General Hospital of Thessaloniki | Thessaloniki | 546 42 | Greece |
| Clinexpert Gyogycentrum | Budapest | 1033 | Hungary |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc | 3526 | Hungary |
| Shaare Zedek Medical Center | Jerusalem | Jerusalem | 91031 | Israel |
| Hadassah Medical Center - PPDS | Jerusalem | Jerusalem | 91120 | Israel |
| Rambam Medical Center - PPDS | Haifa | 31096 | Israel |
| Carmel Medical Center | Haifa | 3436212 | Israel |
| Schneider Childrens Medical Center of Israel Petah Tikvah PIN | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Azienda Ospedaliera Universitaria Federico II | Naples | Campania | 80131 | Italy |
| Azienda USL di Bologna | Bologna | Emilia-Romagna | 40133 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza | Rome | Lazio | 00161 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo | Monza | Monza E Brianza | 20900 | Italy |
| Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN | Florence | Tuscany | 50139 | Italy |
| AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2 | Naples | 280138 | Italy |
| Kurume University Hospital | Kurume | Hukuoka | 830-0011 | Japan |
| Juntendo University Hospital | Bunkyo-Ku | Tokyo | 113-8431 | Japan |
| National Center for Child Health and Development | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | 861-8520 | Japan |
| Saitama Children's Medical Center | Saitama | 330-8777 | Japan |
| Uniwersytecki Szpital Dzieciecy | Krakow | Lesser Poland Voivodeship | 30-663 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Masovian Voivodeship | 00-728 | Poland |
| Instytut 'Pomnik - Centrum Zdrowia Dziecka' | Warsaw | Masovian Voivodeship | 04-736 | Poland |
| Korczowski Bartosz, Gabinet Lekarski | Rzeszów | Podkarpackie Voivodeship | 35-302 | Poland |
| Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach | Katowice | Silesian Voivodeship | 40-752 | Poland |
| Twoja Przychodnia SCM | Szczecin | West Pomeranian Voivodeship | 71-434 | Poland |
| SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251 | Lodz | Łódź Voivodeship | 91-738 | Poland |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Łódź Voivodeship | 93-338 | Poland |
| Kyungpook National University Chilgok Hospital | Daegu | Daegu Gwang'yeogsi | 41404 | South Korea |
| Gachon University Gil Medical Center | Seoul | Incheon Gwang'yeogsi | 3080 | South Korea |
| Samsung Medical Center | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | 21565 | South Korea |
| The Royal London Hospital | London | London, City of | E1 1BB | United Kingdom |
| Great Ormond Street Hospital | London | London, City of | WC1N 3JH | United Kingdom |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | West Midlands | B4 6NH | United Kingdom |
| Noahs Ark Childrens Hospital for Wales | Cardiff | CF14 4XW | United Kingdom |
| FG001 | Participants >15 to <30 kg: Vedolizumab 200 mg | Participants with UC who had a baseline weight of greater than (>)15 to less than (<) 30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| FG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of greater than or equal to (>=) 30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| FG003 | Participants With All Weight Groups Combined: Vedolizumab Low Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of >10 to <15 kg and >=15 to <30 kg, and 150 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
| FG004 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
| Switched Weight Group From 10-15kg to >15kg to <30kg Weight |
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| Switched Weight Group From >15 to <30kg to >=30kg Weight Group |
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2: Maintenance (up to 40 Weeks) |
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The intent to treat (ITT) analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was determined not to be a screen failure. Participants were not required to receive any dose of vedolizumab to be included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants 10 to 15 kg: Vedolizumab 150 mg | Participants with UC who had a baseline weight of 10 to 15 kg received a dose of vedolizumab 150 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| BG001 | Participants >15 to <30 kg: Vedolizumab 200 mg | Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| BG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score | Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy). Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | The intent to treat-maintenance (ITT-M) analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
|
|
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| Secondary | Percentage of Participants With Clinical Remission at Week 14 Based on Modified Mayo Score | Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was determined not to be a screen failure. Participants were not required to receive any dose of vedolizumab to be included in the ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 14 |
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| Secondary | Percentage of Participants With Sustained Clinical Remission at Week 54 Based on Modified Mayo Score | Participants who had clinical remission at Week 14 were analyzed for sustained clinical remission at Week 54. Clinical remission based on the modified Mayo score was defined as stool frequency sub score 0 to 1 and a decrease of 1 or more from baseline, rectal bleeding sub score of 0, and endoscopy sub score 0 to 1 (modified so that a score of 1 does not include friability) and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
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| Secondary | Percentage of Participants With Sustained Endoscopic Remission at Week 54 | Participants who had endoscopic remission at Week 14 were analyzed for sustained endoscopic remission at Week 54. Mayo endoscopic sub score (MES) was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Response at Week 14 | Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was not a screen failure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 14 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Response at Week 54 | Endoscopic response was defined as a decrease from baseline in the MES >=1 point. MES was a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale was graded from 0 to 3 based on the findings on endoscopy where 0=normal or inactive disease, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
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| Secondary | Percentage of Participants With Corticosteroid-free Clinical Remission at Week 54 | Corticosteroid-free clinical remission based on the modified Mayo score was defined as when a participant meets the definition described in the primary endpoint and was off corticosteroids at least 12 weeks prior to and at Week 54 and without presence of any intercurrent event. Modified Mayo score was a composite index of 3 disease activity variables (stool frequency, rectal bleeding, and endoscopy. Each subscale was graded from 0 to 3 where higher score indicated more severe disease. These scores were summed to give a total score range of 0 to 9 where, higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
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| Secondary | Percentage of Participants With Clinical Remission at Week 54 Based on Complete Mayo Score | Clinical remission based on complete Mayo score was a score (inclusive of physician global assessment [PGA]) of <=2 points with no individual sub score >1 and without presence of any intercurrent event. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 94% Confidence Interval | percentage of participants | At Week 54 |
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| Secondary | Serum Trough Concentrations of Vedolizumab Over Time | Serum trough concentration of vedolizumab was reported. | PKAS-M: All participants who received at least 1 dose with measurable drug concentration in blood. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "overall number of participants" are participants evaluable for this Outcome and "number analyzed" signifies participants at the specific categories. | Posted | Mean | Standard Deviation | microgram/ml (mcg/ml) | Predose at Week 14 and post dose at Week 54 |
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| Secondary | Percentage of Participants With Positive Anti-vedolizumab Antibodies (AVA) | AVA positive was defined as a confirmed AVA positive result. | The Safety analysis set maintenance (SAF-M) included all participants who received at least 1 maintenance dose of study vedolizumab. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to Week 54 |
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| Secondary | Percentage of Participants With Positive Neutralizing AVA | Positive Neutralizing AVA was defined as a positive result in the neutralizing AVA assay at any visit. | The SAF-M included all participants who received at least 1 maintenance dose of study vedolizumab. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to Week 54 |
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| Secondary | Percentage of Participants With Sustained Clinical Response at Week 54 Based on Complete Mayo Score | Participants who had clinical response at Week 14 were analyzed for sustained clinical response at Week 54. Sustained refers to meeting the specific endpoint criteria at both Week 14 and Week 54. Sustained clinical response is defined as meeting the following criteria at both Week 14 and Week 54: reduction in complete Mayo score of >=3 points and >=30% from baseline with an accompanying decrease in rectal bleeding sub score of >=1 point or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. Complete Mayo score was a composite index of 4 disease activity variables (stool frequency, rectal bleeding, endoscopy [modified so that a score of 1 does not include friability], and PGA sub scores) ranging from 0-12. Higher score indicated more severe disease. | The ITT-M analysis set included all participants who were randomized into the maintenance period. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 54 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response up to Week 54 Based on Partial Mayo Score | Clinical response was where a participant achieved clinical response if they had a reduction of >=2 points and >=25% from the baseline partial Mayo score, including a >=1 point decrease in the Mayo stool frequency sub score and a >=1 point reduction in the rectal bleeding sub score or absolute rectal bleeding sub score of <=1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease. | The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was determined not to be a screen failure. Participants continued to be evaluated according to their originally assigned induction treatment arms within the ITT framework, hence, analyses for this outcome measure are presented for the ITT population, regardless of subsequent randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Remission up to Week 54 Based on Partial Mayo Score | Clinical remission based on partial Mayo score was defined as a partial Mayo score of <=2 points and no individual sub score >1 point. Mayo score was an instrument designed to measure disease activity of UC. A partial Mayo score was defined as composite index of 3 disease activity variables (stool frequency, rectal bleeding, and PGA sub scores) that ranged from 0-9 and excluded the endoscopy sub score. Higher score indicates more severe disease. | The ITT analysis set included all enrolled participants for the induction period, defined by when the informed consent form was obtained, and the participant was determined not to be a screen failure. Participants continued to be evaluated according to their originally assigned induction treatment arms within the ITT framework, hence, analyses for this outcome measure are presented for the ITT population, regardless of subsequent randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
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| Secondary | Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and Adverse Event of Special Interest (AESI) | A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug through Week 54 for participants entering the extension study or the final safety visit 18 weeks after their last dose of study drug for those who do not enter the extension study or those who early terminate. A TESAE was defined as an undesirable event that was not present prior to medical treatment or an already present event that worsened either in intensity or frequency following the first dose of study drug, that occurred from the first dose of study drug to the day of last dose of study drug + 126 days. AESI was defined as an AE (serious or nonserious) of medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. AESIs include infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]). | The SAF included all participants who received at least 1 dose of study vedolizumab. | Posted | Number | percentage of participants | From first dose of study drug up to end of follow up (up to 3.7 years) |
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| Secondary | Change From Baseline in Weight | Change from baseline in weight was reported. | ITT-M analysis set. As ITT-M is defined based on maintenance eligibility, and does not exclude induction-period assessments, data for these participants were also presented within the analysis. Participants who shifted weight categories between both phases were dosed according to their weight at randomization; therefore their weight group was summarized as predefined in analysis plan. Here "number analyzed" signifies participants who were evaluable for specific categories in the outcome measure. | Posted | Mean | Standard Deviation | kilograms (kg) | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
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| Secondary | Change From Baseline in Weight Z-score | Change from baseline in weight Z-score was reported. Weight z-score expresses how an individual's measured weight compares to the expected weight of a reference population of the same age and sex, standardized using population growth charts. It represents the number of standard deviations (SDs) an individual's weight is above or below the mean of the reference population. Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean. | ITT-M analysis set. As ITT-M is defined based on maintenance eligibility, and does not exclude induction-period assessments, data for these participants were also presented within the analysis. Participants who shifted weight categories between both phases were dosed according to their weight at randomization; therefore their weight group was summarized as predefined in analysis plan. Here "number analyzed" signifies participants who were evaluable for specific categories in the outcome measure. | Posted | Mean | Standard Deviation | Z-score | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
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| Secondary | Change From Baseline in Height | Change from baseline in height was reported. | ITT-M analysis set. As ITT-M is defined based on maintenance eligibility, and does not exclude induction-period assessments, data for these participants were also presented within the analysis. Participants who shifted weight categories between both phases were dosed according to their weight at randomization; therefore their weight group was summarized as predefined in analysis plan. Here "number analyzed" signifies participants who were evaluable for specific categories in the outcome measure. | Posted | Mean | Standard Deviation | centimeters (cm) | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
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| Secondary | Change From Baseline in Linear Growth Z-score | Change from baseline in linear growth Z-score were reported. Linear growth Z-score is a standardized measure that describes how far a measured height deviates from the median height of a reference population of the same age and sex based on established growth charts. It is expressed in units of standard deviations (SD). Z-score was calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score indicates that the observed value is below (lower than) the reference mean, while a positive Z-score indicates that the observed value is above (higher than) the reference mean. | ITT-M analysis set. As ITT-M is defined based on maintenance eligibility, and does not exclude induction-period assessments, data for these participants were also presented within the analysis. Participants who shifted weight categories between both phases were dosed according to their weight at randomization; therefore their weight group was summarized as predefined in analysis plan. Here "number analyzed" signifies participants who were evaluable for specific categories in the outcome measure. | Posted | Mean | Standard Deviation | Z-score | At Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54 |
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| Secondary | Number of Participants With Change From Baseline in Tanner Stage at Week 54 | Tanner stages are used to evaluate growth parameters. They are standardized for age, sex, and pubertal development, with Stage 1 representing the prepubertal stage and Stage 5 representing the fully mature adult stage. It measures Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The data reported shows shifts in participants' Tanner stages from baseline to Week 54. | ITT-M analysis set. Participants who shifted weight categories between the induction and maintenance phases were dosed according to their weight at randomization; therefore, their weight group was summarized as predefined in the analysis plan. Here "Overall Number of Participants Analyzed" signifies participants with both Male and Female pubertal development stages and "number analyzed" signifies participants who were evaluable for the specific categories in the outcome measure. | Posted | Count of Participants | Participants | At Week 54 |
|
From first dose of study drug up to end of follow up (up to 3.7 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants 10 to 15 kg: Vedolizumab 150 mg | Participants with UC who had a baseline weight of 10 to 15 kg received a dose of vedolizumab 150 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Participants >15 to <30 kg: Vedolizumab 200 mg | Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. | 0 | 27 | 4 | 27 | 16 | 27 |
| EG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. | 0 | 90 | 9 | 90 | 34 | 90 |
| EG003 | Participants With All Weight Groups Combined: Vedolizumab Low Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of >10 to <15 kg and >=15 to <30 kg, and 150 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. | 0 | 47 | 3 | 47 | 28 | 47 |
| EG004 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. | 0 | 46 | 5 | 46 | 22 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenovirus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2025 | Feb 25, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Withdrawal by Parent/Guardian |
|
| Failure to Meet Continuation Criteria |
|
| Protocol Deviation |
|
| Other |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants >15 to <30 kg: Vedolizumab 200 mg |
Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| OG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
|
|
| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
|
|
Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
|
|
| OG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
|
|
Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
|
|
| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| OG001 | Participants >15 to <30 kg: Vedolizumab 200 mg | Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| OG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
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Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| OG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
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| OG001 | Participants >15 to <30 kg: Vedolizumab 200 mg | Participants with UC who had a baseline weight of >15 to <30 kg received a dose of vedolizumab 200 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| OG002 | Participants >=30 kg: Vedolizumab 300 mg | Participants with UC who had a baseline weight of >=30 kg received a dose of vedolizumab 300 mg, as an IV infusion at Day 1, Weeks 2 and 6. Participants who achieved clinical response at Week 14 were randomized to receive either low-dose or high-dose vedolizumab administered intravenously Q8W from Week 14 through Week 46. |
| OG003 | Participants With All Weight Groups Combined: Vedolizumab Low Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab low dose arm received 100 mg for baseline weight of >10 to <15 kg and >=15 to <30 kg, and 150 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
| OG004 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| OG001 | Participants With All Weight Groups Combined: Vedolizumab High Dose | Participants from induction phase who achieved a clinical response at Week 14 were randomized to either low dose or high dose treatment arm. Participants with UC randomized to vedolizumab high dose arm received 150 mg for baseline weight of >10 to <15 kg, 200 mg for >=15 to <30 kg, and 300 mg for >=30 kg as an IV infusion Q8W from Week 14 through Week 46. |
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| Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 1 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 2 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 3 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 4 (Baseline) - Tanner Stage 5 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 1 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 2 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 3 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 4 (Week 54) |
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| Tanner Stage 5 (Baseline) - Tanner Stage 5 (Week 54) |
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