Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408629
• Other study ID #: M06-827
• Secondary ID: 2006-002782-40
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2006
• Last updated: April 28, 2011
• Start date: November 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria : Federal Ministry for Labour, Health, and Social AffairsBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyIsrael: Ministry of HealthNew Zealand: MedsafeNorway: Norwegian Medicines AgencyPoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

Description:

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

The duration of the study was up to 65 weeks, including a Screening Period of up to 3 weeks, a double-blind (DB) placebo-controlled treatment period of up to 52 weeks, and a 70 day follow-up phone call for participants who prematurely discontinued or who did not enroll in the extension study NCT# 00573794 (M10-223).

Adult participants with moderate to severe UC (Mayo score of 6 to 12 points with endoscopy subscore of 2 to 3 points), confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy, were to be enrolled at approximately 120 sites worldwide. Planned enrollment was 500 participants.

Participants were to be stratified by prior exposure to infliximab and/or other anti-TNF agents, and randomized in a 1:1 ratio to receive ADA or placebo by subcutaneous injection. Participants assigned to the ADA treatment arm were to receive an induction dose of 160 mg at Week 0 and 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4. Participants assigned to the placebo treatment arm were to receive matching placebo during the same period of time. At or after Week 10, participants who met the criteria for inadequate response could be switched to open-label (OL) ADA 40 mg eow beginning at Week 12. Inadequate response was defined as:

• Partial Mayo score greater than or equal to Baseline score on 2 consecutive visits at least 14 days apart (for participants with a partial Mayo score of 4 to 7 at Baseline).

• Partial Mayo score greater than or equal to 7 on 2 consecutive visits at least 14 days apart (for participants with a partial Mayo score of 8 or 9 at Baseline).

Participants who demonstrated inadequate response at 2 consecutive visits at least 14 days apart while on OL administration ADA 40 mg eow were permitted to dose escalate to ADA 40 mg weekly (ew). Participants with persistent inadequate response while on ADA 40 mg ew may have been discontinued from the study at the Investigator's discretion. Upon completion of the study, participants had the option to enroll into the OL extension Study M10-223 in which they could receive ADA treatment.

Efficacy and safety measurements were performed throughout the study. A follow-up phone call was made 70 days after the last dose of study drug to obtain information on any ongoing or new adverse events (AEs) for all participants who terminated early or who did not enroll in the OL extension study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants >=18 years of age and in good health (Investigator discretion) with a recent stable medical history

2. Diagnosis of UC for greater than 90 days prior to Baseline

3. Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection

4. Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):

• Stable oral corticosteroid dose (prednisone >= 20 mg/day or equivalent) for at least 14 days prior to Baseline or maintenance, corticosteroid dose (prednisone < 20 mg/day or equivalent) for at least 40 days prior to Baseline

and/or

• At least a 90 day course of azathioprine (AZA) or 6-mercaptopurine (6-MP) prior to Baseline, with a dose of AZA >= 1.5 mg/kg/day or 6-MP >= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Participant must be on a stable dose for at least 28 days prior to Baseline.

Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (AZA or 6-MP) during the past 5 years and in the judgment of the Investigator have failed to respond to, or could not tolerate, their treatment.

5. Participants may have been included if they had previously used an anti-tumor necrosis factor (TNF) agent (except ADA) and discontinued its use due to a loss of response or intolerance to the agent.

6. Had to be able to self-administer or had caregiver who could reliably administer subcutaneous (SC) injections.

7. Had to be able and willing to give written informed consent and to comply with the requirements of the study protocol.

8. Female had to be either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug. Examples of approved methods of birth control included the following:

• Condoms, sponge, foams, jellies, diaphragm, or intrauterine device

• Oral, parenteral, intravaginal contraceptives for 90 days prior to study drug administration

• A vasectomized partner The results of the serum pregnancy test performed at the Screening Visit and urine pregnancy test performed at the Baseline Visit must have been negative.

9. Judged to be in generally good health as determined by the Investigator

Exclusion Criteria:

1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC, or planned bowel surgery.

2. Received previous treatment with ADA or previous participation in an ADA clinical study.

3. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Baseline.

4. Received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening Period.

5. Received therapeutic enema or suppository, other than required for endoscopy, within 14 days of the Screening endoscopy and during the remainder of the Screening Period.

6. Current diagnosis of fulminant colitis and/or toxic megacolon.

7. Disease limited to the rectum (ulcerative proctitis).

8. Current diagnosis of indeterminate colitis.

9. Current diagnosis and/or history of Crohns disease (CD).

10. Currently receiving total parenteral nutrition.

11. Used aminosalicylates for < 90 days before Baseline or not on a stable dose for at least 28 days before Baseline or discontinued use within 28 days of Baseline.

12. Positive Clostridium difficile stool assay.

13. Previously used infliximab or any anti-TNF agent within 56 days of Baseline.

14. Previously used infliximab or any anti-TNF agent without clinical response at any time ("primary non-responder") unless subject experienced a treatment-limiting reaction.

15. Infections requiring treatment with IV antibiotics, antivirals, or antifungals within 30 days of Baseline or oral antibiotics, antivirals, or antifungals within 14 days of Baseline.

16. History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Screening colonoscopy/flexible sigmoidoscopy showed evidence of dysplasia or a malignancy, subject was not to be enrolled in the study.

17. History of listeria, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system demyelinating disease, or untreated tuberculosis (TB).

18. Female subject who was pregnant or breast-feeding or considering becoming pregnant during the study (there should be at least 150 days between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential).

19. Poorly controlled medical condition(s), such as uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure (CHF), recent cerebrovascular accident, and any other condition, which in the opinion of the investigator, put the subject at risk by participation in the protocol.

20. Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever was longer).

21. History of clinically significant drug or alcohol abuse during the past year.

22. Known hypersensitivity to the excipients of ADA as stated in the label.

23. Any prior exposure to Tysabri® (natalizumab), or Orencia® (abatacept) or any other biological therapy [other than Kineret® (anakinra) and anti-TNF agents].

24. Currently taking both budesonide and prednisone (or equivalent) simultaneously.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• adalimumab
Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.
• placebo
Matching Placebo for prefilled syringe, 40 mg,

Locations

Country	Name	City	State
Argentina	Site Ref # / Investigator 6853	Buenos Aires
Australia	Site Ref # / Investigator 16141	Bankstown	New South Wales
Australia	Site Ref # / Investigator 10706	Bedford Park	South Australia
Australia	Site Ref # / Investigator 14882	Box Hill	Victoria
Australia	Site Ref # / Investigator 10704	Fremantle	Western Australia
Australia	Site Ref # / Investigator 13722	Garran	Australian Capital Territory
Australia	Site Ref # / Investigator 13723	Herston	Queensland
Australia	Site Ref # / Investigator 9002	Malvern	Victoria
Austria	Site Ref # / Investigator 9802	Vienna
Belgium	Site Ref # / Investigator 5256	Bonheiden
Belgium	Site Ref # / Investigator 5253	Brussels
Belgium	Site Ref # / Investigator 6225	Brussels
Belgium	Site Ref # / Investigator 6079	Ghent
Belgium	Site Ref # / Investigator 6078	Leuven
Canada	Site Ref # / Investigator 3769	Hamilton	Ontario
Canada	Site Ref # / Investigator 10423	Kelowna	British Columbia
Canada	Site Ref # / Investigator 3764	Montreal	Quebec
Canada	Site Ref # / Investigator 3768	Montreal	Quebec
Canada	Site Ref # / Investigator 3771	Montreal	Quebec
Canada	Site Ref # / Investigator 3770	Quebec City	Quebec
Canada	Site Ref # / Investigator 13556	Sudbury	Ontario
Canada	Site Ref # / Investigator 3736	Toronto	Ontario
Canada	Site Ref # / Investigator 3766	Victoria	British Columbia
Czech Republic	Site Ref # / Investigator 7021	Ceske Budejovice
Czech Republic	Site Ref # / Investigator 6307	Hradec Kravlove 12
Czech Republic	Site Ref # / Investigator 6606	Olomouc
Czech Republic	Site Ref # / Investigator 7481	Prague 4
Czech Republic	Site Ref # / Investigator 7479	Prague 5
Denmark	Site Ref # / Investigator 6483	Hvidovre
Denmark	Site Ref # / Investigator 7477	Odense C
France	Site Ref # / Investigator 6231	Clichy
France	Site Ref # / Investigator 7476	Lille Cedex
France	Site Ref # / Investigator 7475	Pessac Cedex
France	Site Ref # / Investigator 7474	Toulouse
Germany	Site Ref # / Investigator 15321	Hamburg
Germany	Site Ref # / Investigator 9069	Hamburg
Germany	Site Ref # / Investigator 14642	Magdeburg
Germany	Site Ref # / Investigator 9067	Minden
Germany	Site Ref # / Investigator 14761	Muenster
Germany	Site Ref # / Investigator 14661	Munich
Germany	Site Ref # / Investigator 9801	Munich
Germany	Site Ref # / Investigator 5247	Regensburg
Hungary	Site Ref # / Investigator 5025	Budapest
Hungary	Site Ref # / Investigator 7485	Budapest
Hungary	Site Ref # / Investigator 10625	Debrecen
Hungary	Site Ref # / Investigator 14104	Gyula
Hungary	Site Ref # / Investigator 4987	Miskoic
Hungary	Site Ref # / Investigator 5036	Miskolc
Israel	Site Ref # / Investigator 12744	Kfar Saba
Israel	Site Ref # / Investigator 10623	Petah Tikva
Israel	Site Ref # / Investigator 15361	Tel Aviv
New Zealand	Site Ref # / Investigator 13181	Auckland
New Zealand	Site Ref # / Investigator 13301	Auckland
New Zealand	Site Ref # / Investigator 13148	Christchurch
New Zealand	Site Ref # / Investigator 13482	Hamilton
Norway	Site Ref # / Investigator 9561	Gjovik
Norway	Site Ref # / Investigator 5197	Oslo
Norway	Site Ref # / Investigator 6297	Oslo
Norway	Site Ref # / Investigator 5194	Tromso
Norway	Site Ref # / Investigator 5193	Trondheim
Poland	Site Ref # / Investigator 5242	Lodz
Poland	Site Ref # / Investigator 5265	Warsaw
Poland	Site Ref # / Investigator 5266	Warsaw
Poland	Site Ref # / Investigator 15263	Wroclaw
Portugal	Site Ref # / Investigator 5264	Faro
Portugal	Site Ref # / Investigator 5263	Lisbon
Portugal	Site Ref # / Investigator 7473	Lisbon
Spain	Site Ref # / Investigator 5211	Barcelona
Spain	Site Ref # / Investigator 5212	Madrid
Switzerland	Site Ref # / Investigator 10221	Basel
Switzerland	Site Ref # / Investigator 10222	Bern
Switzerland	Site Ref # / Investigator 9162	Zurich
United States	Site Ref # / Investigator 5394	Anaheim	California
United States	Site Ref # / Investigator 3759	Annapolis	Maryland
United States	Site Ref # / Investigator 3762	Annapolis	Maryland
United States	Site Ref # / Investigator 3739	Atlanta	Georgia
United States	Site Ref # / Investigator 3752	Charlotte	North Carolina
United States	Site Ref # / Investigator 3745	Cincinnati	Ohio
United States	Site Ref # / Investigator 3741	Columbia	South Carolina
United States	Site Ref # / Investigator 12903	Gainesville	Florida
United States	Site Ref # / Investigator 3737	Germantown	Tennessee
United States	Site Ref # / Investigator 3756	Great Neck	New York
United States	Site Ref # / Investigator 3754	Hamden	Connecticut
United States	Site Ref # / Investigator 3747	Hollywood	Florida
United States	Site Ref # / Investigator 3758	Jacksonville	North Carolina
United States	Site Ref # / Investigator 5106	Jacksonville	Florida
United States	Site Ref # / Investigator 3738	Lutherville	Maryland
United States	Site Ref # / Investigator 7658	Macon	Georgia
United States	Site Ref # / Investigator 5397	Moline	Illinois
United States	Site Ref # / Investigator 11601	Naples	Florida
United States	Site Ref # / Investigator 3743	Nashville	Tennessee
United States	Site Ref # / Investigator 5107	Nashville	Tennessee
United States	Site Ref # / Investigator 6077	Nashville	Tennessee
United States	Site Ref # / Investigator 5398	Ogden	Utah
United States	Site Ref # / Investigator 7709	Oklahoma City	Oklahoma
United States	Site Ref # / Investigator 3744	Rochester	Minnesota
United States	Site Ref # / Investigator 6846	Sarasota	Florida
United States	Site Ref # / Investigator 3765	Sayre	Pennsylvania
United States	Site Ref # / Investigator 3750	Spokane	Washington
United States	Site Ref # / Investigator 8064	Spokane	Washington
United States	Site Ref # / Investigator 6088	St. Louis	Missouri
United States	Site Ref # / Investigator 7453	Topeka	Kansas
United States	Site Ref # / Investigator 7472	Troy	Michigan
United States	Site Ref # / Investigator 3740	Tulsa	Oklahoma
United States	Site Ref # / Investigator 3761	West Bend	Wisconsin
United States	Site Ref # / Investigator 3753	Wheat Ridge	Colorado
United States	Site Ref # / Investigator 3742	Winter Park	Florida
United States	Site Ref # / Investigator 3760	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  Israel,  New Zealand,  Norway,  Poland,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).	Week 8	No
Primary	Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 52	No
Secondary	Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 8, Week 52	No
Secondary	Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8	Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 8	No
Secondary	Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52	Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 52	No
Secondary	Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52	Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 8, Week 52	No
Secondary	Proportion of Participants Who Achieved Mucosal Healing at Week 8	Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).	Week 8	No
Secondary	Proportion of Participants Who Achieved Mucosal Healing at Week 52	Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).	Week 52	No
Secondary	Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52	Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).	Week 8, Week 52	No
Secondary	Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Baseline to Week 52	No
Secondary	Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8	The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).	Week 8	No
Secondary	Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8	SFS ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control.	Week 8	No
Secondary	Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8	RBS ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed	Week 8	No
Secondary	Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Baseline to Week 52	No
Secondary	Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52	Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).	Week 32, Week 52	No
Secondary	Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52	Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).	Week 52	No
Secondary	Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8	Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).	Week 8	No