A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Colitis, Ulcerative Clinical Trial

Official title:

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779307
• Other study ID #: MLN0002-3024
• Secondary ID: 2020-004300-34jR
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• Participants ≥30 kg, Vedolizumab 300 mg

• Participants >15 to <30 kg, Vedolizumab 200 mg

• Participants 10 to 15 kg, Vedolizumab 150 mg

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:

• Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose)

• Participants >15 to <30 kg, Vedolizumab 200 mg (High dose) or 100 mg (Low dose)

• Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).

2. Weighs =10 kg at the time of screening and enrollment into the study.

3. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of =2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.

4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), immunomodulators, and/or tumor necrosis factor alpha (TNF-a) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.

5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.

6. Has extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.

7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.

5. Has received any live vaccinations within 30 days prior to first dose of study drug.

6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.

7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.

8. Participants with a current diagnosis of indeterminate colitis.

9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.

10. 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:

• Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR

• A TB skin test reaction =5 mm. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.

11. 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]).

12. 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.

13. Has positive stool studies for ova and/or parasites or stool culture at screening visit.

14. Has positive Clostridioides difficile (C difficile) stool test at screening visit.

Other inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Vedolizumab
Vedolizumab IV infusion.

Locations

Country	Name	City	State
Australia	Monash Health, Monash Medical Centre	Clayton	Victoria
Australia	Royal Children's Hospital Melbourne - PIN	Parkville	Victoria
Australia	Queensland Childrens Hospital	South Brisbane	Queensland
Australia	Children's Hospital at Westmead	Westmead	New South Wales
Belgium	UZ Antwerpen	Edegem	Antwerpen
Belgium	Universitair Ziekenhuis Brussel - PIN	Jette	Brussels
Belgium	Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg	Leuven	Vlaams Brabant
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
China	Beijing Children's Hospital, Capital Medical University - PIN	Beijing	Beijing
China	The Children's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Henan Children's Hospital Zhengzhou Children's Hospital	Zhengzhou	Henan
Croatia	University Hospital of Split	Split
Croatia	Klinika Za Djecje Bolesti Zagreb	Zagreb	Grad Zagreb
Croatia	University Hospital Center Zagreb - Kispaticeva 12	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Kralovske Vinohrady - CRC - PPDS	Praha
Czechia	Fakultni Thomayerova Nemocnice - CRC - PPDS	Praha
Greece	Children's Hospital "Agia Sofia"	Athens	Attiki
Greece	Attikon University General Hospital	Chaidari	Attiki
Greece	Ippokratio General Hospital of Thessaloniki	Thessaloniki
Hungary	Clinexpert Gyogycentrum	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz	Miskolc
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center - PPDS	Haifa
Israel	Hadassah Medical Center - PPDS	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Schneider Childrens Medical Center of Israel Petah Tikvah PIN	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda USL di Bologna	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN	Firenze	Toscana
Italy	Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo	Monza	Monza E Brianza
Italy	AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli	Campania
Italy	Azienda Ospedale Universita Padova	Padova	Veneto
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza	Roma	Lazio
Japan	Juntendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Kurume University Hospital	Kurume	Hukuoka
Japan	Saitama Children's Medical Center	Saitama
Japan	National Center for Child Health and Development	Setagaya-ku	Tokyo
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Daegu Gwang'yeogsi
Korea, Republic of	Gachon University Gil Medical Center	Seoul	Incheon Gwang'yeogsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Poland	Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach	Katowice	Slaskie
Poland	Uniwersytecki Szpital Dzieciecy	Krakow	Malopolskie
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz	Lodzkie
Poland	SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251	Lodz	Lodzkie
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow	Podkarpackie
Poland	Twoja Przychodnia SCM	Szczecin	Zachodniopomorskie
Poland	Instytut 'Pomnik - Centrum Zdrowia Dziecka'	Warszawa	Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa	Mazowieckie
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham	West Midlands
United Kingdom	Noahs Ark Childrens Hospital for Wales	Cardiff
United Kingdom	Great Ormond Street Hospital	London	London, City Of
United Kingdom	The Royal London Hospital	London	London, City Of
United States	Childrens Center For Digestive Healthcare	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University Hospitals Cleveland Medical Center - 11100 Euclid Ave	Cleveland	Ohio
United States	Texas Childrens Hospital West Campus	Houston	Texas
United States	MNGI Digestive Health PA-Plymouth	Minneapolis	Minnesota
United States	Goryeb Children's Hospital	Morristown	New Jersey
United States	The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS	New Hyde Park	New York
United States	Advocate Children's Hospital Park Ridge	Park Ridge	Illinois
United States	Phoenix Childrens Hospital -1919 E Thompson Rd	Phoenix	Arizona
United States	UPMC Children's Hospital of Pittsburgh-120 Lytton Ave	Pittsburgh	Pennsylvania
United States	Carilion Children's Tanglewood Center	Roanoke	Virginia
United States	Mayo Clinic - PIN	Rochester	Minnesota
United States	Rady Childrens Hospital San Diego - PIN	San Diego	California
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Croatia,  Czechia,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score	Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.	Week 54
Secondary	Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score	Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.	Week 14
Secondary	Percentage of Participants with Sustained Clinical Remission at Week 14 Based on Modified Mayo Score	Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.	Week 14
Secondary	Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score	Sustained clinical remission is where a participant achieves clinical remission at Weeks 14 and 54, based on the modified Mayo score. It is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.	Week 54
Secondary	Percentage of Participants with Sustained Endoscopic Remission at Week 14	Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is 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 scores indicate more severe disease.	Week 14
Secondary	Percentage of Participants with Sustained Endoscopic Remission at Week 54	Sustained endoscopic remission was defined as Mayo endoscopic score (MES) of =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is 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 scores indicate more severe disease.	Week 54
Secondary	Percentage of Participants with Endoscopic Response at Week 14	Endoscopic response was defined as a decrease in MES by =1 grade. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is 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 scores indicate more severe disease.	Week 14
Secondary	Percentage of Participants with Endoscopic Response at Week 54	Endoscopic response was defined as a decrease in MES by =1 point. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is 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 scores indicate more severe disease.	Week 54
Secondary	Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54	Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 54, and was off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission based on the modified Mayo score is defined as stool frequency subscore 0 to 1 and a decrease of 1 or more from Baseline; rectal bleeding subscore of 0; and, endoscopy subscore 0 to 1 (modified so that a score of 1 does not include friability). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy). Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.	Week 54
Secondary	Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score	Clinical remission based on the complete Mayo score is where a participant achieved a complete Mayo score =2 points with no individual subscore >1 at Week 54. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.	Week 54
Secondary	Serum Trough Concentrations of Vedolizumab over Time		Predose and postdose at multiple time points (up to 54 weeks)
Secondary	Percentage of Participants with Positive Anti-vedolizumab Antibodies (AVA)		Predose (up to 54 weeks)
Secondary	Percentage of Participants with Positive Neutralizing AVA		Predose (up to 54 weeks)
Secondary	Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score	Clinical response is where a participant has a reduction in complete Mayo score of =3 points and =30% from Baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.	Week 14
Secondary	Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score	Clinical response is where a participant has a reduction in complete Mayo score of =3 points and =30% from Baseline with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point. Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool frequency, rectal bleeding, Mayo endoscopic subscore (findings on endoscopy), and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Here, higher score indicates more severe disease.	Week 54
Secondary	Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score	Clinical response is defined as reduction of =2 points and =25% from the Baseline partial Mayo score, including a =1-point decrease in the Mayo stool frequency subscore and a =1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of =1 point. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Physician's global assessment. Each subscale is graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Higher score indicates more severe disease.	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	A partial Mayo score =2 points and no individual subscore >1 point.	Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Secondary	Percentage of Participants with at least One Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug which does not necessarily have to have a causal relationship with the treatment. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect and/or is a important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. AESIs include: infusion-related reactions and hypersensitivity, serious infection, malignancy, or other (liver injury and progressive multifocal leukoencephalopathy [PML]).	Up to 158 weeks
Secondary	Change from Baseline in Weight	Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.	Baseline, up to Week 54
Secondary	Change from Baseline in Linear Growth Z-score	Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.	Baseline, up to Week 54
Secondary	Change in Tanner Stage at Week 54 Compared with Baseline	Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants are evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages.	Week 54

External Links

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