A Safety Extension Study of Ontamalimab in Participants W... | NCT03283085 | Trialant
NCT03283085
Sponsor
Shire
Status
Completed
Last Update Posted
Jun 21, 2024Actual
Enrollment
557Actual
Phase
Phase 3
Conditions
Crohn's Disease
Ulcerative Colitis
Interventions
25 mg Ontamalimab
75 mg Ontamalimab
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
NCT03283085
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SHP647-304
Secondary IDs
ID
Type
Description
Link
2017-000574-11
EudraCT Number
Brief Title
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Official Title
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
May 2024
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
Feb 27, 2018Actual
Primary Completion Date
Dec 13, 2023Actual
Completion Date
Dec 13, 2023Actual
First Submitted Date
Sep 12, 2017
First Submission Date that Met QC Criteria
Sep 12, 2017
First Posted Date
Sep 14, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 24, 2024
Results First Submitted that Met QC Criteria
May 24, 2024
Results First Posted Date
Jun 21, 2024Actual
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
May 24, 2024
Last Update Posted Date
Jun 21, 2024Actual
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
Detailed Description
Not provided
Conditions Module
Conditions
Crohn's Disease
Ulcerative Colitis
Keywords
Immunosuppressants
Mesalamine
Ulcerative Colitis
Crohn's disease
Gastroenteritis
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
557Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ulcerative Colitis (UC): Ontamalimab 25 mg
Experimental
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
Drug: 25 mg Ontamalimab
UC: Ontamalimab 25mg then 75 mg
Experimental
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Drug: 25 mg Ontamalimab
Drug: 75 mg Ontamalimab
UC: Ontamalimab 75 mg
Experimental
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Drug: 75 mg Ontamalimab
Crohn's disease (CD): Ontamalimab 25 mg
Experimental
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
Drug: 25 mg Ontamalimab
CD: Ontamalimab 25mg then 75 mg
Experimental
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
25 mg Ontamalimab
Drug
Ontamalimab SC solution for injection
CD: Ontamalimab 25mg then 75 mg
Crohn's disease (CD): Ontamalimab 25 mg
UC: Ontamalimab 25mg then 75 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
From first dose of study drug up to end of study [EOS] (up to 5.79 years)
Number of Participants With Serious Infections
Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.
From first dose of study drug up to EOS (up to 5.79 years)
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.
From first dose of study drug up to EOS (up to 5.79 years)
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.
From first dose of study drug up to EOS (up to 5.79 years)
Number of Participants With Discernible Changes in Vital Signs Over Time
Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Ulcerative Colitis With Treatment Response Over Time
Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with Ulcerative Colitis (UC):
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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria:
a. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2 points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point or a subscore for RB <or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to the baseline value for induction studies.
Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time.
Participants with Crohn's Disease:
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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria:
Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction study and fulfilled the maintenance study response criteria, OR
Participants have received ontamalimab at the maintenance study ET or Week 52 visit:
i) CDAI score that has decreased by >or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25% compared to the baseline value for induction studies.
Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.
Exclusion Criteria:
Participants with UC:
Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
Participants who are likely to require major surgery for UC.
Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, females who are lactating, 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 (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 [e.g.], renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g. 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 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.
Participants with Crohn's Disease:
Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (>) 450.
Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue appropriate contraception methods (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.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants from induction and maintenance studies of ulcerative colitis (UC) [SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and SHP647-303 (NCT03290781)] and Crohn's disease (CD) [SHP647-305 (NCT03559517), SHP647-306 (NCT03566823), and SHP647-307 (NCT03627091)] were enrolled to receive either 25 milligrams (mg) or 75 mg ontamalimab.
Recruitment Details
Participants took part in the study at 225 investigative sites in 33 countries from 27 February 2018 to 13 December 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
FG001
UC: Ontamalimab 25 mg Then 75 mg
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 21, 2020
May 23, 2024
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
Drug: 25 mg Ontamalimab
Drug: 75 mg Ontamalimab
CD: Ontamalimab 75 mg
Experimental
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Drug: 75 mg Ontamalimab
Ulcerative Colitis (UC): Ontamalimab 25 mg
PF-00547659
SHP647
75 mg Ontamalimab
Drug
Ontamalimab SC solution for injection
CD: Ontamalimab 25mg then 75 mg
CD: Ontamalimab 75 mg
UC: Ontamalimab 25mg then 75 mg
UC: Ontamalimab 75 mg
SHP647
PF-00547659
From first dose of study drug up to EOS (up to 5.79 years)
Up to 5.79 years
Number of Participants With Crohn's Disease With Treatment Response Over Time
Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence & size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;>2cm=3);extent of ulcerated surface(none=0;<10%=1;10%-30%=2; >30%= 3);extent of affected surface(none=0;<50%=1;50%-75%=2;>75%=3);Presence & type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).
Up to 5.79 years
Phoenix
Arizona
85018
United States
Arizona Digestive Health
Sun City
Arizona
85351
United States
CATS Research Center - University of Arizona
Tucson
Arizona
85724
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
Tibor Rubin VA Medical Center - NAVREF
Long Beach
California
90822
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
Advanced Clinical Research Network
Miami
Florida
33174
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
34110
United States
Bayside Clinical Research - New Port Richey
New Port Richey
Florida
34655
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
Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
Columbus
Georgia
31904
United States
Atlanta Center For Gastroenterology PC
Decatur
Georgia
30033
United States
Infinite Clinical Trials
Morrow
Georgia
30260
United States
Atlanta Gastroenterology Specialists, PC
Suwanee
Georgia
30024
United States
Loretto Hospital
Chicago
Illinois
60644
United States
IL Gastroenterology Group
Gurnee
Illinois
60041
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
Cotton O'Neil Clinical Research Center
Topeka
Kansas
66606
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
DelRicht Clinical Research, LLC - ClinEdge - PPDS
New Orleans
Louisiana
70115
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, LLC
Chesterfield
Michigan
48047
United States
National Clinical, LLC
Hamtramck
Michigan
48212
United States
Gastroenterology Associates of Western Michigan, PLC
Wyoming
Michigan
49519
United States
Mayo Clinic Health System - PPDS
Duluth
Minnesota
55805
United States
Minnesota Gastroenterology PA
Saint Paul
Minnesota
55114
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
Great Neck
New York
11021
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
Gastro Health Research
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
Penn State Hershey Medical Group
State College
Pennsylvania
16803
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
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
Biopharma Informatic 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
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
Webster
Texas
77598
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
LKH-Universitätsklinikum Klinikum Graz
Graz
Styria
8036
Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt
9020
Austria
Salzburger Landeskliniken
Salzburg
5020
Austria
Universitätsklinikum St. Pölten
Sankt Pölten
3100
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 Leuven- Gasthuisberg Campus
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
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
Medical Center Excelsior OOD - PPDS
Sofia
1000
Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia
1202
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
University Multiprofile Hospital for Active Treatment Sveta Anna
Sofia
1709
Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
Varna
9000
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
Fundación Valle Del Lili
Cali
Valle del Cauca Department
760026
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
Vukovar
32000
Croatia
General Hospital Zadar
Zadar
23 000
Croatia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové
Hradec Králové Region
500 12
Czechia
PreventaMed s.r.o.
Olomouc
Olomouc Region
779 00
Czechia
Institut Klinicke A Experimentalni Mediciny
Prague
140 21
Czechia
ISCARE I.V.F. a.s.
Prague
170 00
Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
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
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
Smoensk
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
Clinical Hospital Center Zemun
Zemun
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
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
C.H. Regional Reina Sofia - PPDS
Córdoba
Córdoba
14004
Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada
Madrid
28942
Spain
Hospital General Universitario Gregorio Maranon
Madrid
Madrid, Communidad Delaware
28007
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
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR
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
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv
61058
Ukraine
MNPE of Kharkiv Regional Council Regional Clinical Specialised 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
Medical Center OK!Clinic+LLC International Institute of Clinical Research
Kyiv
02091
Ukraine
Medical Center of LLC Medical Center Dopomoga-Plus
Kyiv
02132
Ukraine
Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital
Kyiv
04073
Ukraine
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv
04107
Ukraine
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
Lviv
79007
Ukraine
MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance
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
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
Aberdeen Royal Infirmary - PPDS
Aberdeen
AB25 2ZN
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
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
FG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
FG003
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
FG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
FG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
FG00089 subjects
FG001159 subjects
FG002268 subjects
FG0035 subjects
FG00410 subjects
FG00526 subjects
COMPLETED
FG0000 subjects
FG001117 subjects
FG002129 subjects
FG0030 subjects
FG0046 subjects
FG00512 subjects
NOT COMPLETED
FG00089 subjects
FG00142 subjects
FG002139 subjects
FG0035 subjects
FG0044 subjects
FG00514 subjects
Type
Comment
Reasons
Adverse Event
FG00018 subjects
FG0013 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
Death
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00042 subjects
FG00121 subjects
FG00266 subjects
FG0033 subjects
FG004
Physician Decision
FG00014 subjects
FG0018 subjects
FG00219 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00012 subjects
FG0016 subjects
FG00224 subjects
FG0031 subjects
FG004
Reason not Specified
FG0000 subjects
FG0014 subjects
FG0028 subjects
FG0030 subjects
FG004
The Safety Set included all participants who received at least 1 dose of investigational product (IP) in the SHP647-304 study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
BG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
BG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
BG003
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
BG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
BG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00089
BG001159
BG002268
BG0035
BG00410
BG00526
BG006557
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0012
BG0027
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00167
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG00112
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
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 Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Posted
Count of Participants
Participants
From first dose of study drug up to end of study [EOS] (up to 5.79 years)
ID
Title
Description
OG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
OG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
OG003
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
OG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG00089
OG001159
OG002268
OG003
Title
Denominators
Categories
Title
Measurements
OG00067
OG001122
OG002203
OG003
Primary
Number of Participants With Serious Infections
Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.
The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Posted
Count of Participants
Participants
From first dose of study drug up to EOS (up to 5.79 years)
ID
Title
Description
OG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
OG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
OG003
CD: Ontamalimab 25 mg
Primary
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.
The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Posted
Count of Participants
Participants
From first dose of study drug up to EOS (up to 5.79 years)
ID
Title
Description
OG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
OG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
OG003
CD: Ontamalimab 25 mg
Primary
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.
The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Posted
Count of Participants
Participants
From first dose of study drug up to EOS (up to 5.79 years)
ID
Title
Description
OG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
OG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
OG003
Primary
Number of Participants With Discernible Changes in Vital Signs Over Time
Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Posted
Count of Participants
Participants
From first dose of study drug up to EOS (up to 5.79 years)
ID
Title
Description
OG000
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
OG001
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG002
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
OG003
CD: Ontamalimab 25 mg
Secondary
Number of Participants With Ulcerative Colitis With Treatment Response Over Time
Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
Full Analysis Set (FAS) included all participants in the randomized set who received at least 1 dose of IP in the SHP647-304 study. Overall number analyzed is the number of UC participants with data available for analyses.
Posted
Count of Participants
Participants
Up to 5.79 years
ID
Title
Description
OG000
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG001
UC: Ontamalimab 75 mg
Secondary
Number of Participants With Crohn's Disease With Treatment Response Over Time
Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence & size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;>2cm=3);extent of ulcerated surface(none=0;<10%=1;10%-30%=2; >30%= 3);extent of affected surface(none=0;<50%=1;50%-75%=2;>75%=3);Presence & type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).
FAS included all participants in randomized set who received at least 1 dose of IP in the SHP647-304 study. With implementation of protocol amendment 4 this became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those CD participants who were receiving ontamalimab 75mg Q4W and participating in amendment 4 of the protocol were analyzed. Overall number analyzed is the number of CD participants with data available for analyses.
Posted
Count of Participants
Participants
Up to 5.79 years
ID
Title
Description
OG000
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Time Frame
From first dose of study drug up to EOS (up to 5.79 years)
Description
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
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
UC: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
0
89
15
89
47
89
EG001
UC: Ontamalimab 25mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
0
159
21
159
109
159
EG002
UC: Ontamalimab 75mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, forup to 5.79 years.
3
268
46
268
155
268
EG003
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
1
5
2
5
3
5
EG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
0
10
2
10
8
10
EG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
0
26
4
26
14
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG0030 affected5 at risk
EG0040 affected10 at risk
EG0050 affected26 at risk
Acoustic neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0012 affected159 at risk
EG0024 affected268 at risk
EG003
Anaemia macrocytic
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected159 at risk
EG0024 affected268 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Chest pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0021 affected268 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0006 affected89 at risk
EG0013 affected159 at risk
EG00210 affected268 at risk
EG003
Colon dysplasia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0022 affected268 at risk
EG003
Cytomegalovirus gastrointestinal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Death
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Fibroadenoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0021 affected268 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0023 affected268 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0011 affected159 at risk
EG0023 affected268 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0021 affected268 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0022 affected268 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0020 affected268 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0010 affected159 at risk
EG0021 affected268 at risk
EG003
Urticaria chronic
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected89 at risk
EG0011 affected159 at risk
EG0020 affected268 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
OG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG00089
OG001159
OG002268
OG0035
OG00410
OG00526
Title
Denominators
Categories
Title
Measurements
OG0005
OG0014
OG00217
OG0030
OG0040
OG0050
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
OG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG00089
OG001159
OG002268
OG0035
OG00410
OG00526
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
OG0030(0 to 0)
OG0040(0 to 0)
OG0050(0 to 0)
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
OG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG00089
OG001159
OG002268
OG0035
OG00410
OG00526
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
OG0030(0 to 0)
OG0040(0 to 0)
OG0050(0 to 0)
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
OG004
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
OG005
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG00089
OG001159
OG002268
OG0035
OG00410
OG00526
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
OG0030(0 to 0)
OG0040(0 to 0)
OG0050(0 to 0)
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Units
Counts
Participants
OG000120
OG001133
Title
Denominators
Categories
Title
Measurements
OG000116
OG001129
OG001
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.