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CompletedNCT03283085Updated Jun 21, 2024Results posted

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 interventional study of 25 mg Ontamalimab and 75 mg Ontamalimab in Crohn's Disease and Ulcerative Colitis, sponsored by Shire. Completed at 419 sites in 37 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Shire · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
557
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Crohn's Disease
  • Ulcerative Colitis

Keywords

  • Immunosuppressants
  • Mesalamine
  • Ulcerative Colitis
  • Crohn's disease
  • Gastroenteritis
03

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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:

    1. 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
    2. 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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
557 participants (actual)

Study arms

  • Experimental
    Ulcerative Colitis (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.

    Drug: 25 mg Ontamalimab

  • Experimental
    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 5.79 years.

    Drug: 25 mg Ontamalimab · Drug: 75 mg Ontamalimab

  • Experimental
    UC: Ontamalimab 75 mg

    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Drug: 75 mg Ontamalimab

  • Experimental
    Crohn's disease (CD): Ontamalimab 25 mg

    Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

    Drug: 25 mg Ontamalimab

  • Experimental
    CD: 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 5.79 years.

    Drug: 25 mg Ontamalimab · Drug: 75 mg Ontamalimab

  • Experimental
    CD: Ontamalimab 75 mg

    Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

    Drug: 75 mg Ontamalimab

Interventions

  • Drug25 mg Ontamalimab

    Ontamalimab SC solution for injection

    Also known as: PF-00547659, SHP647

  • Drug75 mg Ontamalimab

    Ontamalimab SC solution for injection

    Also known as: SHP647, PF-00547659

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From first dose of study drug up to end of study [EOS] (up to 5.79 years)

  2. 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.

    Time frame: From first dose of study drug up to EOS (up to 5.79 years)

  3. 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.

    Time frame: From first dose of study drug up to EOS (up to 5.79 years)

  4. 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.

    Time frame: From first dose of study drug up to EOS (up to 5.79 years)

  5. 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.

    Time frame: From first dose of study drug up to EOS (up to 5.79 years)

Secondary outcomes

  1. 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.

    Time frame: Up to 5.79 years

  2. 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).

    Time frame: Up to 5.79 years

06

Results

Posted Jun 21, 2024

Participant flow

Participants took part in the study at 225 investigative sites in 33 countries from 27 February 2018 to 13 December 2023.

Participant flow — Overall Study
MilestoneUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Started8915926851026
Completed01171290612
Not completed89421395414
Withdrew: Adverse event18313005
Withdrew: Death003100
Withdrew: Withdrawal by subject422166335
Withdrew: Physician decision14819002
Withdrew: Site terminated by sponsor103000
Withdrew: Lost to follow-up202001
Withdrew: Pregnancy001000
Withdrew: Lack of efficacy12624110
Withdrew: Reason not specified048001

Outcome measures

PrimaryNumber 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.

Time frame:
From first dose of study drug up to end of study [EOS] (up to 5.79 years)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Treatment Emergent Adverse Events (TEAEs)671222034817
PrimaryNumber 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.

Time frame:
From first dose of study drug up to EOS (up to 5.79 years)
Reported as:
Count of participants · Participants
Number of Participants With Serious Infections
ParticipantsUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Serious Infections5417000
PrimaryNumber 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.

Time frame:
From first dose of study drug up to EOS (up to 5.79 years)
Reported as:
Count of participants · Participants
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
ParticipantsUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)
PrimaryNumber 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.

Time frame:
From first dose of study drug up to EOS (up to 5.79 years)
Reported as:
Count of participants · Participants
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
ParticipantsUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)
PrimaryNumber 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.

Time frame:
From first dose of study drug up to EOS (up to 5.79 years)
Reported as:
Count of participants · Participants
Number of Participants With Discernible Changes in Vital Signs Over Time
ParticipantsUC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Discernible Changes in Vital Signs Over Time0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)
SecondaryNumber 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.

Time frame:
Up to 5.79 years
Reported as:
Count of participants · Participants
Number of Participants With Ulcerative Colitis With Treatment Response Over Time
ParticipantsUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mg
Number of Participants With Ulcerative Colitis With Treatment Response Over Time116129
SecondaryNumber 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).

Time frame:
Up to 5.79 years
Reported as:
Count of participants · Participants
Number of Participants With Crohn's Disease With Treatment Response Over Time
ParticipantsCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Number of Participants With Crohn's Disease With Treatment Response Over Time612

Adverse events

Collected over From first dose of study drug up to EOS (up to 5.79 years). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UC: Ontamalimab 25 mg0/89 (0%)15/89 (16.9%)47/89 (52.8%)
UC: Ontamalimab 25mg Then 75 mg0/159 (0%)21/159 (13.2%)109/159 (68.6%)
UC: Ontamalimab 75mg3/268 (1.1%)46/268 (17.2%)155/268 (57.8%)
CD: Ontamalimab 25 mg1/5 (20%)2/5 (40%)3/5 (60%)
CD: Ontamalimab 25 mg Then 75 mg0/10 (0%)2/10 (20%)8/10 (80%)
CD: Ontamalimab 75 mg0/26 (0%)4/26 (15.4%)14/26 (53.8%)
Most frequent serious events
Showing 10 of 70
Most frequent serious events
EventUC: Ontamalimab 25 mgUC: Ontamalimab 25mg Then 75 mgUC: Ontamalimab 75mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
DeathGeneral disorders0/890/1591/2681/50/100/26
Drug eruptionSkin and subcutaneous tissue disorders0/890/1590/2681/50/100/26
Acoustic neuromaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/890/1590/2680/51/100/26
Calculus urinaryRenal and urinary disorders0/891/1590/2680/51/100/26
Renal colicRenal and urinary disorders0/890/1590/2680/51/100/26
Tendon injuryInjury, poisoning and procedural complications0/890/1590/2680/51/100/26
Colitis ulcerativeGastrointestinal disorders6/893/15910/2680/50/100/26
Anal fistulaGastrointestinal disorders0/890/1590/2680/50/101/26
EnterocolitisGastrointestinal disorders0/890/1590/2680/50/101/26
ProctitisGastrointestinal disorders0/891/1591/2680/50/101/26
Most frequent other events
Showing 10 of 54
Most frequent other events
EventUC: Ontamalimab 25 mgUC: Ontamalimab 25mg Then 75 mgUC: Ontamalimab 75mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mg
Corona virus infectionInfections and infestations2/8940/15957/2680/52/104/26
Colitis ulcerativeGastrointestinal disorders22/8921/15928/2680/50/100/26
ArthralgiaMusculoskeletal and connective tissue disorders3/8910/15913/2680/52/101/26
Asthma-chronic obstructive pulmonary disease overlap syndromeRespiratory, thoracic and mediastinal disorders0/890/1590/2681/50/100/26
Back painMusculoskeletal and connective tissue disorders1/8911/15910/2680/52/101/26
Blood pressure increasedInvestigations0/891/1591/2681/50/100/26
BronchitisInfections and infestations0/899/1598/2680/52/100/26
Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/891/1590/2681/50/100/26
ConstipationGastrointestinal disorders0/891/1593/2681/50/100/26
Dental cariesGastrointestinal disorders1/890/1591/2681/50/101/26

Baseline characteristics

The Safety Set included all participants who received at least 1 dose of investigational product (IP) in the SHP647-304 study.

Age, Categorical
Age, Categorical(Participants)UC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mgTotal
<=18 years02701111
Between 18 and 65 years871482394925512
>=65 years292210034
Sex: Female, Male
Sex: Female, Male(Participants)UC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mgTotal
Female29671111514227
Male60921574512330
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)UC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mgTotal
Hispanic or Latino5121501235
Not Hispanic or Latino841462515924519
Unknown or Not Reported0120003
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UC: Ontamalimab 25 mgUC: Ontamalimab 25 mg Then 75 mgUC: Ontamalimab 75 mgCD: Ontamalimab 25 mgCD: Ontamalimab 25 mg Then 75 mgCD: Ontamalimab 75 mgTotal
American Indian or Alaska Native0240017
Asian7142410046
Native Hawaiian or Other Pacific Islander1000001
Black or African American0240028
White771352314923479
More than one race2230007
Unknown or Not Reported2420109
07

Study locations

419 sites
  • Arizona Digestive Health Mesa - East
    Mesa, Arizona 85206, United States
  • Elite Clinical Studies - Phoenix - Clinedge - PPDS
    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
  • Crystal Biomedical Research
    Miami Lakes, Florida 33065, 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
  • 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
    Saint Louis, Missouri 63110, United States
  • St Louis Center For Clinical Research
    Saint 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

Showing the first 100 of 419 sites across 37 countries.

08

References and documents

Study documents

  • Study protocol · Sep 21, 2020
  • Statistical analysis plan · Sep 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Csr

09

Registry details

Key details

Study ID
NCT03283085
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Feb 27, 2018
Primary completion
Dec 13, 2023
Completion
Dec 13, 2023
Results posted
Jun 21, 2024
Last update
Jun 21, 2024

Study contacts

Study Director
study director · Shire

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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