Trial Outcomes & Findings for Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) (NCT NCT03559517)

NCT ID: NCT03559517

Last Updated: 2021-04-29

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: At Week 16
• Results posted on: 2021-04-29

Participant Flow

The study was conducted at 21 sites in the Unites States, Australia, Israel, Italy, Netherlands, Poland, Romania, Russia and South Africa between 29 August 2018 (first participant first visit) and 08 October 2020 (last participant last visit).

A total of 30 participants were enrolled and randomized into the study, of which 29 participants received study treatment. Other secondary outcome measures were not analyzed due to early termination of the study as per sponsor's decision 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	8	9	12
Overall Study COMPLETED	7	9	12
Overall Study NOT COMPLETED	1	0	0

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 Withdrawal by Subject	1	0	0

Baseline Characteristics

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)

Baseline characteristics by cohort

Measure	Placebo n=8 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=9 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=12 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=29 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 13.78 • n=5 Participants	40.1 years STANDARD_DEVIATION 15.55 • n=7 Participants	38.1 years STANDARD_DEVIATION 17.67 • n=5 Participants	39.2 years STANDARD_DEVIATION 15.50 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	28 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	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	29 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: Full analysis set (FAS) consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	1 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	3 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

Clinical remission was defined as a CDAI score of <150. CDAI assessed 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=8 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=9 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=12 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	3 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	4 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: FAS consisted of all randomized participants who had received at least 1 dose of study treatment.

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=8 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=9 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=12 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	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 16

Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.

Clinical response is 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 16

Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.

Clinical response is 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: Baseline up to Week 16

Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.

Clinical remission is 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 16

Population: 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 16

Population: Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.

Endoscopic healing is 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 16

Population: 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 16

Population: 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 32

Population: 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 32

Population: 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 32

Population: 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

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Ontamalimab 25 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ontamalimab 75 mg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=8 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=9 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=12 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 Crohn's disease	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Intestinal obstruction	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Reproductive system and breast disorders Prostatitis	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)

Other adverse events

Measure	Placebo n=8 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=9 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=12 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.
Cardiac disorders Angina pectoris	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Cardiac disorders Palpitations	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Cardiac disorders Sinus tachycardia	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Anal fistula	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Aphthous ulcer	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Crohn's disease	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	16.7% 2/12 • Number of events 2 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Diarrhoea	25.0% 2/8 • Number of events 2 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Frequent bowel movements	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Gastrointestinal disorders Rectal polyp	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
General disorders Asthenia	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
General disorders Chills	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
General disorders Peripheral swelling	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
General disorders Pyrexia	12.5% 1/8 • Number of events 5 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Infections and infestations Nasopharyngitis	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Infections and infestations Tinea versicolour	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Investigations Body temperature increased	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Investigations Electrocardiogram abnormal	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Investigations Weight decreased	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • Number of events 3 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	16.7% 2/12 • Number of events 2 • From screening up to safety follow-up period (Week 32)
Musculoskeletal and connective tissue disorders Joint effusion	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Nervous system disorders Headache	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Nervous system disorders Syncope	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Reproductive system and breast disorders Menstruation irregular	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	8.3% 1/12 • Number of events 1 • From screening up to safety follow-up period (Week 32)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/8 • From screening up to safety follow-up period (Week 32)	11.1% 1/9 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)
Skin and subcutaneous tissue disorders Night sweats	12.5% 1/8 • Number of events 1 • From screening up to safety follow-up period (Week 32)	0.00% 0/9 • From screening up to safety follow-up period (Week 32)	0.00% 0/12 • From screening up to safety follow-up period (Week 32)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@takeda.com

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