Trial Outcomes & Findings for Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306) (NCT NCT03566823)
NCT ID: NCT03566823
Last Updated: 2021-05-11
Results Overview
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point numerical rating scale \[NRS\] ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or discontinuation before Week 16 were considered failures. Number of participants with clinical remission were reported.
TERMINATED
PHASE3
34 participants
At Week 16
2021-05-11
Participant Flow
The study was conducted at 25 sites in the Unites States, Belgium, Bosnia and Herzegovina, Colombia, Hungary, Japan, Mexico, Slovakia, Republic of Korea, Spain and Ukraine between 17 July 2018 (first participant first visit) and 18 August 2020 (last participant last visit).
A total of 34 participants were enrolled into the study, of which 27 participants completed the study. Other secondary outcome measures were not analyzed due to early discontinuation of the study for reasons unrelated to safety.
Participant milestones
| Measure |
Placebo
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
Participants received ontamalimab 25 milligram (mg), injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
15
|
13
|
|
Overall Study
COMPLETED
|
4
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
Participants received ontamalimab 25 milligram (mg), injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.60 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 11.59 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point numerical rating scale \[NRS\] ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or discontinuation before Week 16 were considered failures. Number of participants with clinical remission were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16
|
3 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 25 percent (%) from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with endoscopic response were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Endoscopic Response at Week 16
|
2 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical remission was defined as a CDAI score of \<150. CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity. Number of participants with clinical remission as measured by CDAI were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16
|
4 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Enhanced endoscopic response was defined as a decrease in SES-CD by matching segments of at least 50% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered non-responders. Number of participants with enhanced endoscopic response were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Enhanced Endoscopic Response at Week 16
|
2 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical remission was defined by 2-item PRO subs-cores of average daily abdominal pain \<=1 (based on the 4 point scale, with scores ranging from 0 \[none\] to 3 \[severe\]) over the 7 most recent days and average daily stool frequency \<=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with enhanced endoscopic response were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16
|
3 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical response was measured by 2-item PRO and defined as meeting at least 1 of the following 2 criteria: 1)A decrease of greater than or equal to (\>=) 30% and at least 2 points from baseline in the average daily worst abdominal pain over the 7 most recent days, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either a) not worsening from baseline and/or b) average daily stool frequency \<=2 of type 6/7 as per the BSFS over the 7 most recent days; 2)A decrease of \>=30% from baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days, with the average daily worst abdominal pain either a) not worsening from baseline and/or b) worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days. Participants with missing data at Week16 or who discontinued before Week 16 were considered failures. Number of participants with clinical response were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16
|
5 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain \<=3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]) over the 7 most recent days and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with clinical remission and endoscopic response were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16
|
1 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The FAS consisted of all participants in the randomized set who had received at least 1 dose of IP.
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain \<=3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]) over the 7 most recent days and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per BSFS ranging from type 1 (separate hard lumps-like stools) to type 7 (entirely liquid stools) over the 7 most recent days. Endoscopic response was defined as a decrease in SES CD of at least 25% from baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 16 or who discontinued before Week 16 were considered failures. Number of participants with complete endoscopic healing were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 Participants
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 Participants
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Number of Participants With Complete Endoscopic Healing at Week 16
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Clinical response was measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Clinical response was measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response). CDAI assesses CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Clinical remission was defined by 2-item PRO subs-cores of average worst daily abdominal pain (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
CD clinical signs and symptoms includes total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity, vomiting frequency, and rectal incontinence frequency.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Endoscopic healing was measured by SES-CD \<=4 and at least 2-point reduction versus baseline and no sub-score \>1 in any individual variable. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12 and 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
The IBDQ is a psychometrically validated PRO instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with IBD, including CD. The IBDQ consists of 32 items, which are grouped into 4 domains and scored as: bowel function (10 to 70), systemic symptoms (5 to 35), emotional status (12 to 84), and social function (5 to 35). The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
The SF-36, version 2 is a generic quality-of-life instrument that has been widely used to assess HRQL of participants. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 32Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Incidence of all cause hospitalizations was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 32Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Total inpatient days were planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 32Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.
Incidence of CD-related surgeries and other surgical procedures were planned to be recorded.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Ontamalimab 25 mg
Ontamalimab 75 mg
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 participants at risk
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 participants at risk
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
15.4%
2/13 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received ontamalimab matching-placebo, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 25 mg
n=15 participants at risk
Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
Ontamalimab 75 mg
n=13 participants at risk
Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe on Week 0 (Day 1), Week 4, Week 8, and Week 12 in a 16-week treatment period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
13.3%
2/15 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Crohn's disease
|
33.3%
2/6 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Respiratory tract infection viral
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Tonsillitis
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Infections and infestations
Ureteritis
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Injury, poisoning and procedural complications
Chest injury
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Investigations
Pain threshold decreased
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
13.3%
2/15 • Number of events 2 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
7.7%
1/13 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
16.7%
1/6 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/15 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From screening up to safety follow-up period (Week 32)
|
6.7%
1/15 • Number of events 1 • From screening up to safety follow-up period (Week 32)
|
0.00%
0/13 • From screening up to safety follow-up period (Week 32)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER