Trial Outcomes & Findings for Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis (NCT NCT04882007)
NCT ID: NCT04882007
Last Updated: 2026-06-23
Results Overview
The Mayo Score measures disease activity for UC. The modified questionnaire has 3 domains (instead of the usual 4): 2 with questions answered by the patient (stool frequency and rectal bleeding) and 1 answered by an endoscopist (mucosal appearance at endoscopy). Each domain is graded from 0 to 3, higher values representing a worse outcome. Total score for modified Mayo Score is calculated as the sum of the three sub-scores, and ranges from 0 to 9.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
From Baseline to Week 10
Results posted on
2026-06-23
Participant Flow
Participant milestones
| Measure |
Lusvertikimab 850 mg, Induction Period
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 450 mg, Induction Period
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo, Induction Period
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 850 mg, Open-Label Extension Period
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 10, 14, 18, 22, 26, 30 and 34 during the Open-Label Extension Period
|
|---|---|---|---|---|
|
Double-Blind Induction Period
STARTED
|
51
|
36
|
49
|
0
|
|
Double-Blind Induction Period
COMPLETED
|
47
|
32
|
42
|
0
|
|
Double-Blind Induction Period
NOT COMPLETED
|
4
|
4
|
7
|
0
|
|
Open-Label Extension
STARTED
|
0
|
0
|
0
|
120
|
|
Open-Label Extension
COMPLETED
|
0
|
0
|
0
|
104
|
|
Open-Label Extension
NOT COMPLETED
|
0
|
0
|
0
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lusvertikimab 850 mg, Induction Period
n=50 Participants
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 450 mg, Induction Period
n=35 Participants
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo, Induction Period
n=49 Participants
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=134 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=50 Participants
|
34 Participants
n=35 Participants
|
44 Participants
n=49 Participants
|
123 Participants
n=134 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=50 Participants
|
1 Participants
n=35 Participants
|
5 Participants
n=49 Participants
|
11 Participants
n=134 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 15.1 • n=50 Participants
|
38.8 years
STANDARD_DEVIATION 10.5 • n=35 Participants
|
42.7 years
STANDARD_DEVIATION 15.9 • n=49 Participants
|
41.6 years
STANDARD_DEVIATION 14.4 • n=134 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=50 Participants
|
13 Participants
n=35 Participants
|
21 Participants
n=49 Participants
|
57 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=50 Participants
|
22 Participants
n=35 Participants
|
28 Participants
n=49 Participants
|
77 Participants
n=134 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Modified Mayo Score (MMS)
|
6.5 units on a scale
STANDARD_DEVIATION 1.0 • n=50 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 1.4 • n=35 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.2 • n=49 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.2 • n=134 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 10Population: Full Analysis Set: all randomized patients with Ulcerative Colitis who received at least one dose of study treatment (2 patients excluded for Crohn's Disease).
The Mayo Score measures disease activity for UC. The modified questionnaire has 3 domains (instead of the usual 4): 2 with questions answered by the patient (stool frequency and rectal bleeding) and 1 answered by an endoscopist (mucosal appearance at endoscopy). Each domain is graded from 0 to 3, higher values representing a worse outcome. Total score for modified Mayo Score is calculated as the sum of the three sub-scores, and ranges from 0 to 9.
Outcome measures
| Measure |
Lusvertikimab 850 mg
n=50 Participants
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 450 mg
n=35 Participants
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo
n=49 Participants
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
|---|---|---|---|
|
Change From Baseline in Modified Mayo Score (MMS) at Week 10
|
-2.41 units on a scale
Interval -2.99 to -1.83
|
-2.68 units on a scale
Interval -3.44 to -1.91
|
-1.52 units on a scale
Interval -2.14 to -0.9
|
SECONDARY outcome
Timeframe: Week 10Population: Full Analysis Set: all randomized patients with Ulcerative Colitis who received at least one dose of study treatment (2 patients excluded for Crohn's Disease).
Clinical remission rate\*: percentage of participants in clinical remission, defined as MMS ≤ 2 points and no individual sub-score of \> 1 point and a rectal bleeding at 0. \*The clinical remission rate is reported with imputation.
Outcome measures
| Measure |
Lusvertikimab 850 mg
n=50 Participants
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 450 mg
n=35 Participants
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo
n=49 Participants
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
|---|---|---|---|
|
Clinical Remission Rate at Week 10
|
12.9 percentage of participants
|
23.8 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 10Population: Full Analysis Set: all randomized patients with Ulcerative Colitis who received at least one dose of study treatment (2 patients excluded for Crohn's Disease).
Endoscopic remission rate\*: percentage of participants with an endoscopic remission, defined by an endoscopic Mayo sub-score = 0. \*The endoscopic remission rate is reported with imputation.
Outcome measures
| Measure |
Lusvertikimab 850 mg
n=50 Participants
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 450 mg
n=35 Participants
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo
n=49 Participants
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
|---|---|---|---|
|
Endoscopic Remission Rate at Week 10
|
19.3 percentage of participants
|
36.7 percentage of participants
|
12.5 percentage of participants
|
Adverse Events
Lusvertikimab 450 mg Induction Period
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Induction Period
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Lusvertikimab 850 mg Open-Label Extension Period
Serious events: 10 serious events
Other events: 49 other events
Deaths: 0 deaths
Lusvertikimab 850 mg Induction Period
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lusvertikimab 450 mg Induction Period
n=36 participants at risk
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo Induction Period
n=49 participants at risk
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 850 mg Open-Label Extension Period
n=120 participants at risk
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 10, 14, 18, 22, 26, 30 and 34 during the Open-Label Extension Period
|
Lusvertikimab 850 mg Induction Period
n=51 participants at risk
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.8%
1/36 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.5%
3/120 • Number of events 3 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Gastrointestinal disorders
Anal Ulcer
|
2.8%
1/36 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
General disorders
Chest Pain
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Asymptomatic Covid-19
|
2.8%
1/36 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/51 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/51 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Vascular disorders
Embolism Venous
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/51 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.83%
1/120 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Covid-19
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
1.7%
2/120 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Complicated Appendicitis
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.83%
1/120 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.83%
1/120 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.83%
1/120 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Vascular disorders
Atheroembolism
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.83%
1/120 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
Other adverse events
| Measure |
Lusvertikimab 450 mg Induction Period
n=36 participants at risk
Participants received Lusvertikimab 450 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Placebo Induction Period
n=49 participants at risk
Participants received Placebo intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
Lusvertikimab 850 mg Open-Label Extension Period
n=120 participants at risk
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 10, 14, 18, 22, 26, 30 and 34 during the Open-Label Extension Period
|
Lusvertikimab 850 mg Induction Period
n=51 participants at risk
Participants received Lusvertikimab 850 mg intravenously (IV) at Weeks 0, 2, and 6 during the Double-Blind Induction Period
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
2.8%
1/36 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
4.1%
2/49 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
10.0%
12/120 • Number of events 12 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
4/36 • Number of events 5 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
5.8%
7/120 • Number of events 9 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
3.9%
2/51 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
1/36 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
4.1%
2/49 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
5.8%
7/120 • Number of events 110 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
2.8%
1/36 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
6.1%
3/49 • Number of events 4 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
8.3%
10/120 • Number of events 12 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
3.9%
2/51 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
General disorders
Pyrexia
|
5.6%
2/36 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/49 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
3.9%
2/51 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
4.1%
2/49 • Number of events 2 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/120 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.0%
1/51 • Number of events 1 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
3.3%
4/120 • Number of events 4 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.5%
3/120 • Number of events 3 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.5%
3/120 • Number of events 5 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/49 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
2.5%
3/120 • Number of events 5 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
0.00%
0/51 • Double Blind Induction Period (from Week 0 to Week 10), Open-Label Extension Period (from Week 10 to Week 34)
Of the 2 patients excluded from the Full Analysis Set, one entered in the Open-Label Extension (OLE) period, thus a total of 120 patients constituted the OLE Safety Analysis Set and 119 the OLE Full Analysis Set.
|
Additional Information
Director of Regulatory Affairs
Ose Immunotherapeutics
Phone: + 33 6 67 51 38 62
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Terms may vary, but usually agreed terms are as follows: "The INSTITUTION and the INVESTIGATOR undertake and agree that they will not publish, communicate or otherwise disclose in whatever manner or through any vehicle any information derived from the Study or the Study Data (i) for the whole duration of the Study, (ii) before the Study Report is notified to the competent authorities and (iii) for a period of eighteen (18) months after the completion of the data analysis for the entire Study."
- Publication restrictions are in place
Restriction type: OTHER