Trial Outcomes & Findings for Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis (NCT NCT02129777)
NCT ID: NCT02129777
Last Updated: 2017-04-07
Results Overview
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Week 12
Results posted on
2017-04-07
Participant Flow
Participants were enrolled into the double-blind treatment evaluation at 17 investigative sites in Canada, Denmark, Germany, Latvia, and Poland. Only those sites in Denmark, Latvia and Poland participated in the extension period which included open-label treatment with study medication.
Participants with diagnosis of moderate to severe plaque psoriasis without clinically significant lung/respiratory disorders were screened for enrollment into the study.To fulfill screening requirements,chest X-ray was carried out prior to Baseline visit which included assignment to the double-blind study treatment and first dosing with study drug.
Participant milestones
| Measure |
Double-Blind Period: Placebo
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Open-Label Period: Namilumab 80 mg
Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Open-Label Period: Namilumab 150 mg
Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
|---|---|---|---|---|---|---|---|
|
Double-Blind Period
STARTED
|
24
|
24
|
24
|
25
|
25
|
0
|
0
|
|
Double-Blind Period
COMPLETED
|
17
|
16
|
20
|
18
|
18
|
0
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
7
|
8
|
4
|
7
|
7
|
0
|
0
|
|
Open-Label Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
12
|
48
|
|
Open-Label Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
48
|
Reasons for withdrawal
| Measure |
Double-Blind Period: Placebo
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Open-Label Period: Namilumab 80 mg
Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Open-Label Period: Namilumab 150 mg
Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
|---|---|---|---|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Period
Lost to Follow-up
|
1
|
1
|
1
|
2
|
0
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
2
|
4
|
3
|
2
|
3
|
0
|
0
|
|
Double-Blind Period
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Period
Lack of Efficacy
|
3
|
1
|
0
|
3
|
2
|
0
|
0
|
|
Double-Blind Period
Other
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Open-Label Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Open-Label Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Open-Label Period
Study Termination
|
0
|
0
|
0
|
0
|
0
|
10
|
39
|
Baseline Characteristics
Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 15.20 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 12.04 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 9.62 • n=21 Participants
|
40.6 years
STANDARD_DEVIATION 11.80 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
56 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
13 participants
n=4 Participants
|
13 participants
n=21 Participants
|
66 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
11 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
23 participants
n=4 Participants
|
21 participants
n=21 Participants
|
109 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
56 participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
Latvia
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
17 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
9 participants
n=21 Participants
|
46 participants
n=8 Participants
|
|
Height
|
172.3 centimeter
STANDARD_DEVIATION 10.83 • n=5 Participants
|
176.1 centimeter
STANDARD_DEVIATION 7.73 • n=7 Participants
|
176.5 centimeter
STANDARD_DEVIATION 7.81 • n=5 Participants
|
176.8 centimeter
STANDARD_DEVIATION 8.59 • n=4 Participants
|
168.1 centimeter
STANDARD_DEVIATION 10.28 • n=21 Participants
|
173.9 centimeter
STANDARD_DEVIATION 9.61 • n=8 Participants
|
|
Weight
|
87.46 kilogram
STANDARD_DEVIATION 22.864 • n=5 Participants
|
88.26 kilogram
STANDARD_DEVIATION 22.033 • n=7 Participants
|
97.84 kilogram
STANDARD_DEVIATION 33.643 • n=5 Participants
|
95.50 kilogram
STANDARD_DEVIATION 25.056 • n=4 Participants
|
82.32 kilogram
STANDARD_DEVIATION 24.634 • n=21 Participants
|
90.25 kilogram
STANDARD_DEVIATION 26.156 • n=8 Participants
|
|
Body Mass Index
|
29.16 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.112 • n=5 Participants
|
28.25 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.936 • n=7 Participants
|
31.26 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 9.532 • n=5 Participants
|
30.53 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 7.641 • n=4 Participants
|
29.01 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 8.093 • n=21 Participants
|
29.64 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 7.539 • n=8 Participants
|
|
Smoking Classification
Never Smoked
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
13 participants
n=4 Participants
|
12 participants
n=21 Participants
|
52 participants
n=8 Participants
|
|
Smoking Classification
Current Smoker
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
5 participants
n=21 Participants
|
34 participants
n=8 Participants
|
|
Smoking Classification
Ex-Smoker
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
8 participants
n=21 Participants
|
36 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=23 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=21 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=22 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=19 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=20 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12
|
8.7 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6 and 10Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
Week 2 (n= 24, 24, 24, 25, 25)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
Week 4 (n= 24, 24, 23, 24, 24)
|
0 percentage of participants
|
0 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
Week 6 (n= 23, 23, 24, 24, 23)
|
4.3 percentage of participants
|
8.7 percentage of participants
|
4.2 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
Week 10 (n= 22, 22, 24, 24, 22)
|
9.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=24, 24, 24, 25, 25)
|
18.6 units on a scale
Standard Error 1.65
|
19.1 units on a scale
Standard Error 1.57
|
20.9 units on a scale
Standard Error 1.62
|
17.4 units on a scale
Standard Error 1.57
|
17.3 units on a scale
Standard Error 1.52
|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=24, 24, 24, 25, 25)
|
-2.2 units on a scale
Standard Error 0.70
|
-1.7 units on a scale
Standard Error 0.67
|
-1.2 units on a scale
Standard Error 0.69
|
-2.1 units on a scale
Standard Error 0.67
|
-1.4 units on a scale
Standard Error 0.65
|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=24, 24, 23, 24, 24)
|
-3.6 units on a scale
Standard Error 0.92
|
-2.8 units on a scale
Standard Error 0.90
|
-1.9 units on a scale
Standard Error 0.92
|
-2.4 units on a scale
Standard Error 0.90
|
-2.2 units on a scale
Standard Error 0.89
|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=23, 23, 24, 24, 23)
|
-5.1 units on a scale
Standard Error 1.13
|
-3.6 units on a scale
Standard Error 1.10
|
-1.4 units on a scale
Standard Error 1.11
|
-2.4 units on a scale
Standard Error 1.10
|
-2.4 units on a scale
Standard Error 1.10
|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=22, 22, 24, 24, 22)
|
-6.4 units on a scale
Standard Error 1.30
|
-4.6 units on a scale
Standard Error 1.29
|
-3.2 units on a scale
Standard Error 1.28
|
-3.2 units on a scale
Standard Error 1.27
|
-3.0 units on a scale
Standard Error 1.28
|
|
Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=23, 21, 22, 19, 20)
|
-6.3 units on a scale
Standard Error 1.27
|
-4.9 units on a scale
Standard Error 1.26
|
-4.4 units on a scale
Standard Error 1.25
|
-3.3 units on a scale
Standard Error 1.26
|
-3.4 units on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 10 and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 50% reduction in PASI score relative to baseline PASI Score are reported.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Week 2 (n= 24, 24, 24, 25, 25)
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Week 4 (n= 24, 24, 23, 24, 24)
|
8.3 percentage of participants
|
4.2 percentage of participants
|
8.7 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Week 6 (n= 23, 23, 24, 24, 23)
|
13.0 percentage of participants
|
13.0 percentage of participants
|
8.3 percentage of participants
|
4.2 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Week 10 (n= 22, 22, 24, 24, 22)
|
22.7 percentage of participants
|
18.2 percentage of participants
|
12.5 percentage of participants
|
8.3 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
Week 12 (n= 23, 21, 22, 19, 20)
|
21.7 percentage of participants
|
19.0 percentage of participants
|
18.2 percentage of participants
|
10.5 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 10 and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 90% reduction in PASI score relative to baseline PASI Score are reported.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Week 2 (n= 24, 24, 24, 25, 25)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Week 4 (n= 24, 24, 23, 24, 24)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Week 6 (n= 23, 23, 24, 24, 23)
|
0 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Week 10 (n= 22, 22, 24, 24, 22)
|
0 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
Week 12 (n= 23, 21, 22, 19, 20)
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 10 and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had \>=2 point improvement are reported.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Week 2 (n= 24, 24, 24, 25, 25)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Week 4 (n= 24, 24, 23, 24, 24)
|
0 percentage of participants
|
4.2 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Week 6 (n= 23, 23, 24, 24, 23)
|
0 percentage of participants
|
13.0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Week 10 (n= 22, 22, 24, 24, 22)
|
13.6 percentage of participants
|
4.5 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
Week 12 (n= 23, 21, 22, 19, 20)
|
13.0 percentage of participants
|
14.3 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 10 and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). 'Clear' and 'Almost clear' included all participants who had scored a 0 or 1.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Week 2 (n= 24, 24, 24, 25, 25)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Week 4 (n= 24, 24, 23, 24, 24)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Week 6 (n= 23, 23, 24, 24, 23)
|
0 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Week 10 (n= 22, 22, 24, 24, 22)
|
0 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
Week 12 (n= 23, 21, 22, 19, 20)
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=22, 22, 24, 24, 22)
|
-0.4 units on a scale
Standard Error 0.12
|
-0.5 units on a scale
Standard Error 0.12
|
-0.4 units on a scale
Standard Error 0.12
|
-0.3 units on a scale
Standard Error 0.12
|
-0.5 units on a scale
Standard Error 0.12
|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=24, 24, 24, 25, 25)
|
3.5 units on a scale
Standard Error 0.11
|
3.5 units on a scale
Standard Error 0.11
|
3.6 units on a scale
Standard Error 0.11
|
3.3 units on a scale
Standard Error 0.11
|
3.6 units on a scale
Standard Error 0.10
|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=24, 24, 24, 25, 25)
|
-0.1 units on a scale
Standard Error 0.08
|
-0.1 units on a scale
Standard Error 0.08
|
-0.2 units on a scale
Standard Error 0.08
|
-0.1 units on a scale
Standard Error 0.08
|
-0.1 units on a scale
Standard Error 0.08
|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=24, 24, 23, 24, 24)
|
-0.1 units on a scale
Standard Error 0.10
|
-0.3 units on a scale
Standard Error 0.10
|
-0.2 units on a scale
Standard Error 0.10
|
-0.2 units on a scale
Standard Error 0.10
|
-0.3 units on a scale
Standard Error 0.09
|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=23, 23, 24, 24, 23)
|
-0.3 units on a scale
Standard Error 0.12
|
-0.5 units on a scale
Standard Error 0.12
|
-0.3 units on a scale
Standard Error 0.12
|
-0.2 units on a scale
Standard Error 0.12
|
-0.2 units on a scale
Standard Error 0.12
|
|
Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=23, 21, 22, 19, 20)
|
-0.4 units on a scale
Standard Error 0.13
|
-0.6 units on a scale
Standard Error 0.13
|
-0.6 units on a scale
Standard Error 0.13
|
-0.4 units on a scale
Standard Error 0.13
|
-0.5 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant's hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant's palm.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=22, 22, 24, 24, 22)
|
-3.24 percentage of total body surface area
Standard Error 1.551
|
-4.55 percentage of total body surface area
Standard Error 1.542
|
-0.63 percentage of total body surface area
Standard Error 1.522
|
0.45 percentage of total body surface area
Standard Error 1.513
|
-0.51 percentage of total body surface area
Standard Error 1.535
|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Baseline (n=24, 24, 24, 25, 25)
|
23.09 percentage of total body surface area
Standard Error 3.674
|
24.39 percentage of total body surface area
Standard Error 3.485
|
26.16 percentage of total body surface area
Standard Error 3.596
|
22.35 percentage of total body surface area
Standard Error 3.497
|
21.84 percentage of total body surface area
Standard Error 3.385
|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=24, 24, 24, 25, 25)
|
-0.59 percentage of total body surface area
Standard Error 0.624
|
-0.22 percentage of total body surface area
Standard Error 0.591
|
0.21 percentage of total body surface area
Standard Error 0.610
|
-0.35 percentage of total body surface area
Standard Error 0.594
|
-0.26 percentage of total body surface area
Standard Error 0.576
|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=24, 24, 23, 24, 24)
|
-0.86 percentage of total body surface area
Standard Error 0.945
|
-1.02 percentage of total body surface area
Standard Error 0.923
|
-0.24 percentage of total body surface area
Standard Error 0.940
|
-0.09 percentage of total body surface area
Standard Error 0.923
|
0.25 percentage of total body surface area
Standard Error 0.911
|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=23, 23, 24, 24, 23)
|
-1.78 percentage of total body surface area
Standard Error 1.366
|
-3.65 percentage of total body surface area
Standard Error 1.351
|
0.43 percentage of total body surface area
Standard Error 1.349
|
0.36 percentage of total body surface area
Standard Error 1.340
|
0.12 percentage of total body surface area
Standard Error 1.343
|
|
Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=23, 21, 22, 19, 20)
|
-3.29 percentage of total body surface area
Standard Error 1.537
|
-3.48 percentage of total body surface area
Standard Error 1.553
|
-1.70 percentage of total body surface area
Standard Error 1.527
|
0.35 percentage of total body surface area
Standard Error 1.559
|
-0.51 percentage of total body surface area
Standard Error 1.560
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with "No itch" at the left extreme and "Worst itch imaginable" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=23, 23, 24, 25, 25)
|
5.35 units on a scale
Standard Error 0.633
|
5.28 units on a scale
Standard Error 0.600
|
5.67 units on a scale
Standard Error 0.610
|
6.08 units on a scale
Standard Error 0.593
|
5.00 units on a scale
Standard Error 0.575
|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=23, 23, 23, 25, 24)
|
-1.34 units on a scale
Standard Error 0.441
|
-1.15 units on a scale
Standard Error 0.418
|
-1.92 units on a scale
Standard Error 0.427
|
-1.42 units on a scale
Standard Error 0.417
|
-1.36 units on a scale
Standard Error 0.402
|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=23, 23, 23, 23, 24)
|
-1.38 units on a scale
Standard Error 0.501
|
-1.46 units on a scale
Standard Error 0.480
|
-2.10 units on a scale
Standard Error 0.486
|
-1.66 units on a scale
Standard Error 0.477
|
-1.48 units on a scale
Standard Error 0.462
|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=22, 22, 24, 22, 23)
|
-1.08 units on a scale
Standard Error 0.502
|
-1.54 units on a scale
Standard Error 0.482
|
-2.01 units on a scale
Standard Error 0.485
|
-1.57 units on a scale
Standard Error 0.479
|
-1.33 units on a scale
Standard Error 0.464
|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=21, 21, 24, 22, 21)
|
-1.12 units on a scale
Standard Error 0.515
|
-1.47 units on a scale
Standard Error 0.497
|
-2.00 units on a scale
Standard Error 0.496
|
-1.51 units on a scale
Standard Error 0.492
|
-1.68 units on a scale
Standard Error 0.481
|
|
Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=22, 20, 22, 17, 20)
|
-0.95 units on a scale
Standard Error 0.523
|
-1.49 units on a scale
Standard Error 0.508
|
-2.11 units on a scale
Standard Error 0.504
|
-1.54 units on a scale
Standard Error 0.508
|
-2.11 units on a scale
Standard Error 0.494
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with "No pain" at the left extreme and "Worst pain imaginable" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=23, 23, 24, 25, 25)
|
1.55 units on a scale
Standard Error 0.618
|
3.45 units on a scale
Standard Error 0.585
|
3.52 units on a scale
Standard Error 0.595
|
3.14 units on a scale
Standard Error 0.579
|
2.13 units on a scale
Standard Error 0.560
|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=23, 23, 23, 25, 24)
|
-0.25 units on a scale
Standard Error 0.334
|
-0.89 units on a scale
Standard Error 0.316
|
-0.81 units on a scale
Standard Error 0.323
|
-0.68 units on a scale
Standard Error 0.311
|
-0.30 units on a scale
Standard Error 0.301
|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=23, 23, 23, 23, 24)
|
-0.28 units on a scale
Standard Error 0.378
|
-1.06 units on a scale
Standard Error 0.362
|
-0.91 units on a scale
Standard Error 0.366
|
-0.89 units on a scale
Standard Error 0.356
|
-0.47 units on a scale
Standard Error 0.346
|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=22, 21, 24, 22, 23)
|
-0.04 units on a scale
Standard Error 0.405
|
-0.84 units on a scale
Standard Error 0.390
|
-0.90 units on a scale
Standard Error 0.391
|
-0.63 units on a scale
Standard Error 0.384
|
-0.47 units on a scale
Standard Error 0.374
|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=21, 21, 24, 22, 21)
|
-0.08 units on a scale
Standard Error 0.417
|
-0.60 units on a scale
Standard Error 0.402
|
-0.77 units on a scale
Standard Error 0.401
|
-0.56 units on a scale
Standard Error 0.396
|
-0.56 units on a scale
Standard Error 0.387
|
|
Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=22, 20, 22, 17, 20)
|
0.51 units on a scale
Standard Error 0.458
|
-0.54 units on a scale
Standard Error 0.449
|
-0.75 units on a scale
Standard Error 0.444
|
-0.47 units on a scale
Standard Error 0.452
|
-0.72 units on a scale
Standard Error 0.436
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with "No stiffness" at the left extreme and "Very severe stiffness" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=23 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=23, 23, 24, 25, 25)
|
1.73 units on a scale
Standard Error 0.592
|
3.32 units on a scale
Standard Error 0.561
|
3.33 units on a scale
Standard Error 0.571
|
2.77 units on a scale
Standard Error 0.555
|
2.32 units on a scale
Standard Error 0.537
|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=23, 23, 23, 25, 24)
|
-0.22 units on a scale
Standard Error 0.276
|
-0.87 units on a scale
Standard Error 0.266
|
-0.91 units on a scale
Standard Error 0.271
|
-0.67 units on a scale
Standard Error 0.259
|
-0.32 units on a scale
Standard Error 0.250
|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=23, 23, 23, 23, 24)
|
-0.31 units on a scale
Standard Error 0.316
|
-0.95 units on a scale
Standard Error 0.307
|
-0.97 units on a scale
Standard Error 0.310
|
-0.80 units on a scale
Standard Error 0.300
|
-0.26 units on a scale
Standard Error 0.291
|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=22, 21, 24, 22, 23)
|
-0.27 units on a scale
Standard Error 0.351
|
-0.84 units on a scale
Standard Error 0.343
|
-0.97 units on a scale
Standard Error 0.342
|
-0.61 units on a scale
Standard Error 0.335
|
-0.21 units on a scale
Standard Error 0.327
|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=21, 21, 24, 22, 21)
|
-0.38 units on a scale
Standard Error 0.372
|
-0.74 units on a scale
Standard Error 0.364
|
-0.94 units on a scale
Standard Error 0.362
|
-0.46 units on a scale
Standard Error 0.356
|
-0.24 units on a scale
Standard Error 0.349
|
|
Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=22, 20, 22, 17, 20)
|
-0.16 units on a scale
Standard Error 0.368
|
-0.79 units on a scale
Standard Error 0.363
|
-1.02 units on a scale
Standard Error 0.359
|
-0.43 units on a scale
Standard Error 0.361
|
-0.24 units on a scale
Standard Error 0.350
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=13 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=17 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=17 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=18 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=18 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=13, 14, 16, 12, 12)
|
-1.4 minutes
Standard Error 5.12
|
-3.0 minutes
Standard Error 4.35
|
6.5 minutes
Standard Error 4.44
|
-0.6 minutes
Standard Error 4.42
|
3.0 minutes
Standard Error 4.56
|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Baseline (n=13, 17, 17, 18, 18)
|
6.6 minutes
Standard Error 5.65
|
14.2 minutes
Standard Error 4.49
|
18.2 minutes
Standard Error 4.84
|
16.6 minutes
Standard Error 4.58
|
12.4 minutes
Standard Error 4.91
|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=13, 16, 17, 17, 17)
|
1.2 minutes
Standard Error 3.33
|
-1.7 minutes
Standard Error 2.67
|
0.1 minutes
Standard Error 2.85
|
-5.3 minutes
Standard Error 2.73
|
-0.2 minutes
Standard Error 2.88
|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=13, 16, 16, 16, 17)
|
-0.9 minutes
Standard Error 3.49
|
-3.0 minutes
Standard Error 2.80
|
2.4 minutes
Standard Error 3.01
|
-2.8 minutes
Standard Error 2.88
|
1.0 minutes
Standard Error 3.03
|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=13, 13, 17, 14, 16)
|
-0.6 minutes
Standard Error 4.06
|
-2.4 minutes
Standard Error 3.39
|
4.1 minutes
Standard Error 3.50
|
-2.0 minutes
Standard Error 3.44
|
1.8 minutes
Standard Error 3.55
|
|
Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=11, 15, 17, 15, 13)
|
-0.9 minutes
Standard Error 4.30
|
-2.3 minutes
Standard Error 3.58
|
5.2 minutes
Standard Error 3.71
|
-2.0 minutes
Standard Error 3.64
|
1.3 minutes
Standard Error 3.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant's quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents "No effect at all on participant's life" and 21-30 "Extremely large effect on participant's life" - higher scores indicating poorer quality of life.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=21 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=21 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=22 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=19 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=19 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
Baseline
|
13.8 units on a scale
Standard Error 1.95
|
12.2 units on a scale
Standard Error 1.85
|
10.3 units on a scale
Standard Error 1.83
|
13.9 units on a scale
Standard Error 1.95
|
11.4 units on a scale
Standard Error 1.89
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
Change at Week 12
|
-0.7 units on a scale
Standard Error 1.06
|
-0.7 units on a scale
Standard Error 1.01
|
-1.9 units on a scale
Standard Error 1.01
|
-2.1 units on a scale
Standard Error 1.06
|
-2.8 units on a scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=20 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=20 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=22 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=19 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=18 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
Physical Health Summary Score: Baseline
|
52.9 units on a scale
Standard Error 2.08
|
46.6 units on a scale
Standard Error 1.97
|
49.0 units on a scale
Standard Error 1.92
|
52.8 units on a scale
Standard Error 2.04
|
50.7 units on a scale
Standard Error 2.05
|
|
Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
Physical Health Summary Score: Change at Week 12
|
-0.5 units on a scale
Standard Error 1.31
|
-2.6 units on a scale
Standard Error 1.24
|
-0.8 units on a scale
Standard Error 1.19
|
0.9 units on a scale
Standard Error 1.28
|
0.4 units on a scale
Standard Error 1.27
|
|
Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
Mental Health Summary Score: Baseline
|
43.7 units on a scale
Standard Error 2.67
|
42.9 units on a scale
Standard Error 2.53
|
42.8 units on a scale
Standard Error 2.46
|
42.3 units on a scale
Standard Error 2.61
|
46.0 units on a scale
Standard Error 2.63
|
|
Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
Mental Health Summary Score: Change at Week 12
|
0.9 units on a scale
Standard Error 1.78
|
2.8 units on a scale
Standard Error 1.69
|
1.5 units on a scale
Standard Error 1.64
|
1.5 units on a scale
Standard Error 1.75
|
1.6 units on a scale
Standard Error 1.76
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=20 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=20 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=22 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=19 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=18 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12
Baseline
|
0.86 units on a scale
Standard Error 0.041
|
0.80 units on a scale
Standard Error 0.038
|
0.84 units on a scale
Standard Error 0.038
|
0.81 units on a scale
Standard Error 0.040
|
0.87 units on a scale
Standard Error 0.040
|
|
Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12
Change at Week 12
|
-0.02 units on a scale
Standard Error 0.033
|
-0.04 units on a scale
Standard Error 0.031
|
-0.04 units on a scale
Standard Error 0.030
|
0.01 units on a scale
Standard Error 0.033
|
0.01 units on a scale
Standard Error 0.033
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm ("Worst imaginable health state") to 100 mm ("Best imaginable health state"); higher scores indicate a better health state.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=16 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=17 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=20 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=17 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=16 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D-VAS Score at Week 12
Baseline
|
76.8 millimeter (mm)
Standard Error 5.77
|
58.9 millimeter (mm)
Standard Error 5.13
|
67.2 millimeter (mm)
Standard Error 5.09
|
75.3 millimeter (mm)
Standard Error 5.42
|
74.3 millimeter (mm)
Standard Error 5.47
|
|
Change From Baseline in EQ-5D-VAS Score at Week 12
Change at Week 12
|
0.5 millimeter (mm)
Standard Error 3.99
|
-0.5 millimeter (mm)
Standard Error 3.67
|
5.3 millimeter (mm)
Standard Error 3.51
|
-1.4 millimeter (mm)
Standard Error 3.74
|
-1.9 millimeter (mm)
Standard Error 3.77
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, and 12Population: FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Outcome measures
| Measure |
Double-Blind Period: Placebo
n=24 Participants
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 Participants
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 Participants
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 Participants
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 Participants
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Baseline (n=24, 24, 24, 25, 25)
|
14.5 units on a scale
Standard Error 3.56
|
9.6 units on a scale
Standard Error 3.37
|
15.6 units on a scale
Standard Error 3.48
|
12.0 units on a scale
Standard Error 3.39
|
12.5 units on a scale
Standard Error 3.28
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Change at Week 2 (n=24, 24, 24, 25, 25)
|
-0.8 units on a scale
Standard Error 0.53
|
0.1 units on a scale
Standard Error 0.50
|
0.8 units on a scale
Standard Error 0.52
|
0.4 units on a scale
Standard Error 0.50
|
0.1 units on a scale
Standard Error 0.48
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Change at Week 4 (n=24, 24, 23, 24, 24)
|
-1.5 units on a scale
Standard Error 0.77
|
0.0 units on a scale
Standard Error 0.75
|
1.4 units on a scale
Standard Error 0.77
|
0.6 units on a scale
Standard Error 0.75
|
0.1 units on a scale
Standard Error 0.74
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Change at Week 6 (n=23, 23, 24, 24, 23)
|
-1.5 units on a scale
Standard Error 0.99
|
-0.2 units on a scale
Standard Error 0.98
|
1.2 units on a scale
Standard Error 0.98
|
2.3 units on a scale
Standard Error 0.97
|
-0.7 units on a scale
Standard Error 0.97
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Change at Week 10 (n=22, 22, 24, 24, 21)
|
-2.4 units on a scale
Standard Error 1.03
|
-0.6 units on a scale
Standard Error 1.02
|
0.8 units on a scale
Standard Error 1.01
|
2.0 units on a scale
Standard Error 1.00
|
0.6 units on a scale
Standard Error 1.02
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
Change at Week 12 (n=23, 21, 22, 19, 20)
|
-1.5 units on a scale
Standard Error 1.17
|
-0.5 units on a scale
Standard Error 1.18
|
0.9 units on a scale
Standard Error 1.16
|
2.5 units on a scale
Standard Error 1.17
|
1.0 units on a scale
Standard Error 1.18
|
Adverse Events
Double-Blind Period: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Double-Blind Period: Namilumab 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Double-Blind Period: Namilumab 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Double-Blind Period: Namilumab 80 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Double-Blind Period: Namilumab 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Open-Label Period: Namilumab 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Open-Label Period: Namilumab 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Follow-up Period: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up Period: Namilumab 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: Namilumab 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: Namilumab 80 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up: Namilumab 150 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Period: Placebo
n=24 participants at risk
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 participants at risk
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 participants at risk
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 participants at risk
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 participants at risk
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Open-Label Period: Namilumab 80 mg
n=12 participants at risk
Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Open-Label Period: Namilumab 150 mg
n=48 participants at risk
Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Follow-up Period: Placebo
n=24 participants at risk
Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 20 mg
n=24 participants at risk
Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 50 mg
n=24 participants at risk
Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 80 mg
n=25 participants at risk
Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up: Namilumab 150 mg
n=25 participants at risk
Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertensive crisis
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Double-Blind Period: Placebo
n=24 participants at risk
Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 20 mg
n=24 participants at risk
Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 50 mg
n=24 participants at risk
Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 80 mg
n=25 participants at risk
Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Double-Blind Period: Namilumab 150 mg
n=25 participants at risk
Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
|
Open-Label Period: Namilumab 80 mg
n=12 participants at risk
Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Open-Label Period: Namilumab 150 mg
n=48 participants at risk
Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
|
Follow-up Period: Placebo
n=24 participants at risk
Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 20 mg
n=24 participants at risk
Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 50 mg
n=24 participants at risk
Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up Period: Namilumab 80 mg
n=25 participants at risk
Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
Follow-up: Namilumab 150 mg
n=25 participants at risk
Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.0%
3/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
2/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/48 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER