An Efficacy and Safety Study of Ontamalimab as Maintenanc... | NCT03290781 | Trialant
NCT03290781
Sponsor
Shire
Status
Completed
Last Update Posted
Jan 14, 2022Actual
Enrollment
366Actual
Phase
Phase 3
Conditions
Ulcerative Colitis
Interventions
Ontamalimab
Placebo
Countries
United States
Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Bulgaria
Canada
Colombia
Croatia
Czechia
Estonia
Germany
Greece
Hungary
Ireland
Israel
Italy
Japan
Lebanon
Lithuania
Mexico
Netherlands
New Zealand
Poland
Portugal
Romania
Russia
Serbia
Slovakia
South Africa
South Korea
Spain
Switzerland
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03290781
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SHP647-303
Secondary IDs
ID
Type
Description
Link
2017-000573-37
EudraCT Number
Brief Title
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Official Title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Acronym
FIGARO UC 303
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Dec 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 4, 2018Actual
Primary Completion Date
Jul 1, 2021Actual
Completion Date
Jul 1, 2021Actual
First Submitted Date
Sep 6, 2017
First Submission Date that Met QC Criteria
Sep 20, 2017
First Posted Date
Sep 25, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 16, 2021
Results First Submitted that Met QC Criteria
Dec 16, 2021
Results First Posted Date
Jan 14, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 16, 2021
Last Update Posted Date
Jan 14, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ShireINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Ulcerative colitis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
366Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ontamalimab 25 mg
Experimental
Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Drug: Ontamalimab
Ontamalimab 75 mg
Experimental
Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Drug: Ontamalimab
Placebo
Placebo Comparator
Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ontamalimab
Drug
Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Remission Based on Composite Score at Week 52
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
At Week 52
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Endoscopic Remission at Week 52
Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
At Week 52
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
Exclusion Criteria:
Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Participants who are likely to require surgery for UC during the study period.
Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].
Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.
See Also Links
Label
URL
To obtain more information on the study, click here/on this link
Participant with moderate to severe Ulcerative Colitis (UC) who achieved a clinical response and completed their treatment period in the induction studies (either SHP647-301 [NCT03259334] or SHP647-302 [NCT03259308]) were randomized into this study as ontamalimab and placebo responders to receive placebo or ONTA 25 milligrams (mg) or 75 mg.
Recruitment Details
This study was conducted at 400 sites from 4 April 2018 (first participant first visit) to 1 July 2021 (last participant last visit). A total of 366 participants were enrolled, randomized and received study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 17, 2020
Dec 10, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Ontamalimab 25 mg
Ontamalimab 75 mg
PF-00547659
SHP647
Placebo
Other
Participants will receive 1 mL of sterile aqueous buffered solution.
Placebo
Number of Participants With Clinical Remission at Week 52
Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
At Week 52
Number of Participants With Sustained Remission at Week 52
Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
At Week 52
Number of Participants With Clinical Response Based on Composite Score at Week 52
Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
At Week 52
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
At Week 52
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).
At Week 52
Number of Participants With Glucocorticoid-free Remission at Week 52
Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
At Week 52
Number of Participants With Remission Based on Total Mayo Score at Week 52
Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].
At Week 52
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Sustained Endoscopic Remission at Week 52
Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
At Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
From start of study drug administration up to follow-up (Week 64)
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
At Week 12, 24, 36 and 52
Phoenix
Arizona
85018
United States
Atria Clinical Research - Clinedge - PPDS
Little Rock
Arkansas
72209
United States
Advanced Research Center
Anaheim
California
92805
United States
Kindred Medical Institute for Clinical Trials, LLC
Corona
California
92879
United States
United Medical Doctors
Encinitas
California
92024-1350
United States
University of California San Diego
La Jolla
California
92093
United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster
California
93534
United States
VA Long Beach Healthcare System - NAVREF - PPDS
Long Beach
California
90822
United States
Facey Medical Foundation
Mission Hills
California
91345
United States
United Medical Doctors
Murrieta
California
92563
United States
Alliance Clinical Research-(Vestavia Hills)
Poway
California
92064
United States
Inland Empire Liver Foundation
Rialto
California
92377
United States
University of California San Francisco
San Francisco
California
94158
United States
Care Access Research, San Pablo
San Pablo
California
94806
United States
Peak Gastroenterology Associates
Colorado Springs
Colorado
80903
United States
Asthma and Allergy Associates PC - CRN - PPDS
Colorado Springs
Colorado
80907
United States
Renaissance Research Medical Group, INC
Cape Coral
Florida
33991
United States
Gastro Florida
Clearwater
Florida
33756
United States
Advanced Clinical Research Network
Coral Gables
Florida
33134
United States
Alliance Medical Research LLC
Coral Springs
Florida
33071
United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
Jacksonville
Florida
32256
United States
SIH Research
Kissimmee
Florida
34741
United States
Hi Tech and Global Research, LLc
Miami
Florida
33135
United States
Nuren Medical and Research Center
Miami
Florida
33144
United States
Sanchez Clinical Research, Inc
Miami
Florida
33157
United States
Crystal Biomedical Research
Miami Lakes
Florida
33065
United States
Gastroenterology Group of Naples
Naples
Florida
34102
United States
Pharma Research International Inc
Naples
Florida
34102
United States
Omega Research Consultants LLC - Clinedge - PPDS
Orlando
Florida
32810
United States
Accel Research Sites - St. Petersburg - ERN - PPDS
Pinellas Park
Florida
33781
United States
BRCR Medical Center, Inc
Plantation
Florida
33322
United States
East Coast Institute for Research, LLC
Saint Augustine
Florida
32086
United States
DBC Research
Tamarac
Florida
33321
United States
Bayside Clinical Research - New Port Richey
Tampa
Florida
33604
United States
Atlanta Gastroenterology Specialists, PC
Atlanta
Georgia
30308
United States
Infinite Clinical Trials
Atlanta
Georgia
30349
United States
Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
Columbus
Georgia
31904
United States
Atlanta Center For Gastroenterology PC
Decatur
Georgia
30033
United States
Loretto Hospital
Chicago
Illinois
60644
United States
IL Gastroenterology Group
Gurnee
Illinois
60031
United States
Edward Hines Jr VA Hospital - NAVREF - PPDS
Hines
Illinois
60141
United States
Dupage Medical Group
Oakbrook Terrace
Illinois
60181
United States
Medisphere Medical Research Center LLC
Evansville
Indiana
47714
United States
Laporte County Institute For Clinical Research
Michigan City
Indiana
46360
United States
Gastroenterology Associates of Hazard
Hazard
Kentucky
41701
United States
CroNOLA, LLC.
Houma
Louisiana
70360
United States
Clinical Trials of SWLA, LLC
Lake Charles
Louisiana
70601
United States
Louisiana Research Center LLC
Shreveport
Louisiana
71103
United States
Chevy Chase Clinical Research
Chevy Chase
Maryland
20815
United States
Commonwealth Clinical Studies LLC
Brockton
Massachusetts
02302
United States
UMass Memorial Medical Center
Worcester
Massachusetts
01655
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Clinical Research Institute of Michigan
Chesterfield
Michigan
48047
United States
National Clinical, LLC
Hamtramck
Michigan
48212
United States
Mayo Clinic Health System - PPDS
Duluth
Minnesota
55805
United States
Digestive Health Center PA
Ocean Springs
Mississippi
39564
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
St Louis Center For Clinical Research
St Louis
Missouri
63128
United States
Advanced Biomedical Research of America
Las Vegas
Nevada
89123
United States
Encompass Care
North Las Vegas
Nevada
89086
United States
New York Total Medical Care PC
Brooklyn
New York
11215
United States
NYU Langone Long Island Clinical Research Associates
Lake Success
New York
11042
United States
Weill Cornell Medical College
New York
New York
10021
United States
Southtowns Gastroenterology, PLLC
Orchard Park
New York
14127
United States
East Carolina Gastroenterology
Jacksonville
North Carolina
28546
United States
Piedmont Healthcare
Statesville
North Carolina
28625
United States
Consultants For Clinical Research Inc
Cincinnati
Ohio
45219
United States
Consultants For Clinical Research Inc
Cincinnati
Ohio
45249
United States
Consultants For Clinical Research Inc
Fairfield
Ohio
45014
United States
Prestige Clinical Research
Franklin
Ohio
45005
United States
Ohio Clinical Research Partners LLC
Mentor
Ohio
44060
United States
Veteran's Research and Education Foundation - NAVREF - PPDS
Oklahoma City
Oklahoma
73104
United States
Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
Pittsburgh
Pennsylvania
15240
United States
Digestive Disease Associates
Wyomissing
Pennsylvania
19610
United States
Gastro One
Germantown
Tennessee
38138
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37212
United States
Advanced Gastroenterology-Union City
Union City
Tennessee
38237
United States
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
Baytown
Texas
77521
United States
Northside Gastroenterology
Cypress
Texas
77429
United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
Garland
Texas
75044
United States
Precision Research Institute, LLC
Houston
Texas
77039
United States
Biopharma Informatic Inc.
Houston
Texas
77043
United States
Southwest Clinical Trials
Houston
Texas
77074
United States
Aztec Medical Research
Houston
Texas
77079
United States
BI Research Center
Houston
Texas
77084
United States
Southern Star Research Institute LLC
San Antonio
Texas
78229
United States
DM Clinical Research - ERN - PPDS
Tomball
Texas
77375
United States
HP Clinical Research
Bountiful
Utah
84010
United States
Mid Atlantic Health Specialists
Galax
Virginia
24333
United States
Winchester Gastroenterology Associates
Winchester
Virginia
22601-2872
United States
CHI Franciscan Digestive Care Associates
Tacoma
Washington
98405
United States
Exemplar Research, Inc. - Elkins
Elkins
West Virginia
26241
United States
West Virginia University Hospital
Morgantown
West Virginia
26506
United States
Fundación Favaloro
Buenos Aires
C1093AAS
Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba
Argentina
Sanatorio 9 de Julio SA
San Miguel de Tucumán
Argentina
Concord Repatriation General Hospital
Concord
New South Wales
2139
Australia
Liverpool Hospital
Liverpool
New South Wales
2170
Australia
Royal Brisbane & Women's Hospital
Herston
Queensland
4029
Australia
Mater Hospital Brisbane
South Brisbane
Queensland
4101
Australia
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
The Alfred Hospital
Box Hill
Victoria
3128
Australia
St Vincents Hospital Melbourne - PPDS
Melbourne
Victoria
3065
Australia
A.ö. Krankenhaus der Barmherzigen Brüder
Sankt Veit an der Glan
Carinthia
9300
Austria
Universitätsklinikum St. Pölten
Sankt Pölten
Saint Pölten
3100
Austria
LKH-Universitätsklinikum Klinikum Graz
Graz
Styria
8036
Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt
9020
Austria
Salzburger Landeskliniken
Salzburg
5020
Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna
1090
Austria
Klinikum Wels-Grieskirchen GmbH
Wels
4600
Austria
UZ Gent
Ghent
Oost-Vlaanderen
9000
Belgium
UZ Gasthuisberg
Leuven
Vlaams Brabant
3000
Belgium
AZ Groeninge
Kortrijk
West-Vlaanderen
8500
Belgium
CHU Mouscron
Mouscron
7700
Belgium
Clinical Center Banja Luka
Banja Luka
78000
Bosnia and Herzegovina
University Multiprofile Hospital for Active Treatment Sveta Anna
Sofia
Sofia-Grad
1750
Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia
Sofia-Grad
1784
Bulgaria
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
Pleven
5800
Bulgaria
Multiprofile Hospital for Active Treatment Eurohospital
Plovdiv
4004
Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
Rousse
7002
Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo
5400
Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia
1202
Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia
1421
Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia
1431
Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia
1431
Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia
1527
Bulgaria
Medical Center Convex EOOD
Sofia
1680
Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
Varna
9020
Bulgaria
Percuro Clinical Research LTD
Victoria
British Columbia
V8P 2P5
Canada
Toronto Digestive Disease Associates Inc
Toronto
Ontario
M3N 2V7
Canada
Hospital Pablo Tobón Uribe
Medellín
Antioquia
050034
Colombia
Servimed S.A.S
Bucaramanga
Santander Department
Colombia
IPS Centro Médico Julián Coronel S.A.S. - PPDS
Cali
Colombia
University Hospital Center Zagreb
Zagreb
City of Zagreb
10000
Croatia
Opca Bolnica Karlovac
Karlovac
Karlovacka Županija
47000
Croatia
Opca bolnica Bjelovar
Bjelovar
43000
Croatia
Clinical Hospital Centre Osijek
Osijek
31000
Croatia
University Hospital Centre Split
Split
21000
Croatia
General Hospital Virovitica
Virovitica
33000
Croatia
General County Hospital Vukovar and Croatian Veterans Hospital
Research Institute of Physiology and Basic Medicine
Novosibirsk
630117
Russia
Rostov State Medical University
Rostov-on-Don
344022
Russia
Rostov State Medical University
Rostov-on-Don
344091
Russia
St. Elizabeth Municipal Clinical Hospital
Saint Petersburg
195257
Russia
First St. Petersburg State Medical University n.a. I.P Pavlov
Saint Petersburg
197022
Russia
Union Clinic, LLC
Saint Petersburg
197110
Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg
Russia
Medical University Reaviz
Samara
443011
Russia
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
Samara
443029
Russia
Medical Company Hepatolog, LLC
Samara
443063
Russia
SHI Regional Clinical Hospital
Saratov
410012
Russia
Smolensk Regional Clinical Hospital
Smolensk
214018
Russia
Stavropol State Medical University
Stavropol
355017
Russia
Regional Consulting and Diagnostics Centre
Tyumen
625026
Russia
Clinical Hospital Center Bezanijska Kosa
Belgrade
11080
Serbia
University Clinical Center Nis
Niš
18000
Serbia
General Hospital Vrsac
Vršac
26300
Serbia
University Clinical Center Kragujevac
Kragujevac
Šumadijski Okrug
34000
Serbia
Univerzitna nemocnica Bratislava
Bratislava
851 07
Slovakia
KM Management, spol. s r.o.
Nitra
949 01
Slovakia
Gastro LM, s.r.o.
Prešov
080 01
Slovakia
CLINRESCO, ARWYP Medical Suites
Johannesburg
Gauteng
1619
South Africa
Dr. J Breedt
Pretoria
Gauteng
0002
South Africa
Dr JP Wright
Claremont
Western Cape
7708
South Africa
Kyungpook National University Hospital
Daegu
Daegu Gwang'yeogsi
41944
South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju
Gang'weondo
26426
South Korea
CHA Bundang Medical Center, CHA University
Seongnam
Gyeonggido
13496
South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Gyeonggido
16247
South Korea
Inje University Haeundae Paik Hospital
Busan
48108
South Korea
Pusan National University Hospital
Busan
49241
South Korea
Yeungnam University Hospital
Daegu
42415
South Korea
Kyungpook National University Chilgok Hospital
Daegu
702-210
South Korea
Gachon University Gil Medical Center
Incheon
21565
South Korea
Kyung Hee University Hospital
Seoul
02447
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Kangbuk Samsung Hospital
Seoul
03181
South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul
03722
South Korea
Asan Medical Center - PPDS
Seoul
05505
South Korea
Samsung Medical Center PPDS
Seoul
06351
South Korea
Inje University Seoul Paik Hospital
Seoul
100-032
South Korea
C.H. Regional Reina Sofia - PPDS
Córdoba
Córdoba
14004
Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada
Madrid
28942
Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo
Pontevedra
36312
Spain
Centro Medico Teknon - Grupo Quironsalud
Barcelona
08022
Spain
Hospital Universitario Juan Ramon Jimenez
Huelva
21005
Spain
Hospital Universitario de La Princesa
Madrid
28006
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Universitario La Paz - PPDS
Madrid
28046
Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville
41013
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
46026
Spain
Universität Zürich
Zurich
Zürich (de)
8091
Switzerland
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul
34098
Turkey (Türkiye)
Mersin University Medical Faculty
Mersin
33169
Turkey (Türkiye)
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
Chernivtsi
Chernivtsi Oblast
58001
Ukraine
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
Kharkiv
Kharkiv Oblast
61037
Ukraine
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv
Kyïv
04107
Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia
Vinnytsia Oblast
21018
Ukraine
Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
Zaporizhzhia
Zaporizhzhia Oblast
69005
Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro
49005
Ukraine
LLC Medical Center Family Medicine Clinic
Dnipro
49038
Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipro
49074
Ukraine
Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
Kharkiv
61039
Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv
61058
Ukraine
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
Kharkiv
61166
Ukraine
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
Kherson
73000
Ukraine
Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
Kryvyi Rih
50056
Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv
01023
Ukraine
Kyiv City Clinical Hospital #18
Kyiv
01030
Ukraine
Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
Kyiv
01033
Ukraine
Municipal Institution of KRC Kyiv Regional Hospital #2
Kyiv
04073
Ukraine
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
Lviv
79007
Ukraine
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Lviv
79059
Ukraine
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
Odesa
65025
Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council
Uzhhorod
88000
Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia
21009
Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia
21018
Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia
21029
Ukraine
MNPE City Hospital No. 6 of Zaporizhzhia City Council
Zaporizhzhia
69035
Ukraine
Aberdeen Royal Infirmary - PPDS
Aberdeen
Aberdeen City
AB25 2ZN
United Kingdom
Fairfield General Hospital - PPDS
Lancashire
Bury
BL9 7TD
United Kingdom
Whipps Cross University Hospital
London
London, City of
E11 1NR
United Kingdom
North Tyneside General Hospital
North Shields
Northumberland
NE29 8NH
United Kingdom
Royal Shrewsbury Hospital
Shrewsbury
Shropshire
SY3 8XQ
United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburh
EH4 2XU
United Kingdom
Royal Gwent Hospital - PPDS
Newport
NP20 2UB
United Kingdom
New Cross Hospital
Wolverhampton
WV10 0QP
United Kingdom
FG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG004
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG005
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG006
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
FG00073 subjects
FG00171 subjects
FG00286 subjects
FG00382 subjects
FG00411 subjects
FG00522 subjects
FG00621 subjects
COMPLETED
FG00024 subjects
FG00153 subjects
FG00230 subjects
FG00359 subjects
FG0046 subjects
FG00519 subjects
FG00617 subjects
NOT COMPLETED
FG00049 subjects
FG00118 subjects
FG00256 subjects
FG00323 subjects
FG0045 subjects
FG0053 subjects
FG0064 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0017 subjects
FG0024 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0015 subjects
FG0029 subjects
FG00310 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Deviation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Disease Relapse
FG00032 subjects
FG0015 subjects
FG00238 subjects
FG0037 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
The safety set consisted of all participants who had received at least 1 dose of Investigational Product (IP) in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG004
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG005
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG006
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00073
BG00171
BG00286
BG00382
BG00411
BG00522
BG00621
BG007366
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00043.3± 15.40
BG00141.2± 13.17
BG00242.0± 13.81
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00129
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
BG002
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
Number of Participants With Remission Based on Composite Score at Week 52
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25 mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG001
ONTA 25 mg/ONTA 25 mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75 mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75 mg/ONTA 75 mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG00138
OG00211
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.451
2-Sided
95
0.296
0.572
Superiority
OG002
Secondary
Number of Participants With Endoscopic Remission at Week 52
Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Clinical Remission at Week 52
Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Sustained Remission at Week 52
Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Clinical Response Based on Composite Score at Week 52
Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Glucocorticoid-free Remission at Week 52
Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Remission Based on Total Mayo Score at Week 52
Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
ID
Title
Description
OG000
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Secondary
Number of Participants With Sustained Endoscopic Remission at Week 52
Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
PParticipants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
Posted
Count of Participants
Participants
From start of study drug administration up to follow-up (Week 64)
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Secondary
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and "number analyzed" refer to the participants evaluable at specific time points.
Posted
Count of Participants
Participants
At Week 12, 24, 36 and 52
ID
Title
Description
OG000
ONTA 25mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Time Frame
From start of study drug administration up to Week 64
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ONTA 25mg/ Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 milligram (mg) of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
0
73
6
73
41
73
EG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
0
71
9
71
27
71
EG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
1
86
9
86
52
86
EG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
0
82
2
82
30
82
EG004
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
1
11
1
11
8
11
EG005
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
0
22
0
22
11
22
EG006
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
0
21
2
21
9
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG0030 events0 affected82 at risk
EG004
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0002 events2 affected73 at risk
EG0011 events1 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Chest discomfort
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Infectious colitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Clostridium test positive
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0022 events1 affected86 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Transient global amnesia
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Bladder metaplasia
Renal and urinary disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Rhinitis hypertrophic
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0002 events2 affected73 at risk
EG0014 events4 affected71 at risk
EG0023 events3 affected86 at risk
EG0031 events1 affected82 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected22 at risk
EG0060 events0 affected21 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0003 events3 affected73 at risk
EG0014 events2 affected71 at risk
EG0024 events4 affected86 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG00017 events17 affected73 at risk
EG0013 events3 affected71 at risk
EG00234 events29 affected86 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0012 events2 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0004 events4 affected73 at risk
EG0014 events3 affected71 at risk
EG0023 events3 affected86 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected71 at risk
EG0022 events2 affected86 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0011 events1 affected71 at risk
EG0024 events4 affected86 at risk
EG003
Viral infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0021 events1 affected86 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Weight increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 events0 affected73 at risk
EG0011 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0005 events4 affected73 at risk
EG0015 events4 affected71 at risk
EG0023 events3 affected86 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 events1 affected73 at risk
EG0012 events1 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0005 events4 affected73 at risk
EG0014 events3 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0003 events3 affected73 at risk
EG0013 events3 affected71 at risk
EG0020 events0 affected86 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.278
2-Sided
95
0.142
0.401
Superiority
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0007
OG00140
OG00213
OG00340
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.463
2-Sided
95
0.310
0.585
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.339
2-Sided
95
0.197
0.463
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG00013
OG00148
OG00219
OG00342
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.497
2-Sided
95
0.337
0.620
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.294
2-Sided
95
0.148
0.425
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0004
OG00123
OG0027
OG00322
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.277
2-Sided
95
0.129
0.398
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.191
2-Sided
95
0.067
0.305
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG00015
OG00149
OG00220
OG00347
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.488
2-Sided
95
0.329
0.613
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.343
2-Sided
95
0.194
0.471
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0006
OG00137
OG00211
OG00329
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.431
2-Sided
95
0.280
0.554
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.227
2-Sided
95
0.094
0.349
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0001
OG00112
OG0023
OG00312
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.176
2-Sided
95
0.049
0.287
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.005
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Difference in Proportion
0.111
2-Sided
95
0.006
0.208
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0000
OG0018
OG0022
OG00310
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
=0.005
P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).
Superiority
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0005
OG00138
OG00210
OG00333
OG001
ONTA 25mg/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
At Week 4
Title
Measurements
OG00028
OG00125
OG00225
OG00324
At Week 8
Title
Measurements
OG00022
OG00125
OG00229
OG003
At Week 12
Title
Measurements
OG00018
OG00126
OG00222
OG003
At Week 16
Title
Measurements
OG00016
OG00132
OG00217
OG003
At Week 20
Title
Measurements
OG00020
OG00125
OG00216
OG003
At Week 24
Title
Measurements
OG00012
OG00131
OG00212
OG003
At Week 28
Title
Measurements
OG00013
OG00131
OG00219
OG003
At Week 32
Title
Measurements
OG00017
OG00135
OG00213
OG003
At Week 36
Title
Measurements
OG00013
OG00137
OG00213
OG003
At Week 40
Title
Measurements
OG00015
OG00134
OG00212
OG003
At Week 44
Title
Measurements
OG00011
OG00127
OG00212
OG003
At Week 48
Title
Measurements
OG00013
OG00132
OG00216
OG003
At Week 52
Title
Measurements
OG0009
OG00133
OG00210
OG003
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
Title
Denominators
Categories
Title
Measurements
OG0004
OG00127
OG0028
OG00329
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG004
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG005
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG006
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
Units
Counts
Participants
OG00073
OG00171
OG00286
OG00382
OG00411
OG00522
OG00621
Title
Denominators
Categories
Title
Measurements
OG00046
OG00141
OG00254
OG00351
OG0048
OG00511
OG00612
OG002
ONTA 75mg/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG003
ONTA 75mg/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG004
Placebo/Placebo
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG005
Placebo/ONTA 25mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.
OG006
Placebo/ONTA 75mg
Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.