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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
557
Ontamalimab SC solution for injection
Ontamalimab SC solution for injection
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)
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)
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)
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)
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)
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Arizona Digestive Health Mesa - East
Mesa, Arizona, United States
Elite Clinical Studies - Phoenix - Clinedge - PPDS
Phoenix, Arizona, United States
Arizona Digestive Health
Sun City, Arizona, United States
CATS Research Center - University of Arizona
Tucson, Arizona, United States
Atria Clinical Research - Clinedge - PPDS
Little Rock, Arkansas, United States
Advanced Research Center
Anaheim, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
United Medical Doctors
Encinitas, California, United States
University of California San Diego
La Jolla, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, United States
...and 409 more locations
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
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