Trial Outcomes & Findings for Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis (NCT NCT01900431)
NCT ID: NCT01900431
Last Updated: 2017-06-20
Results Overview
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 \[low opacity\] to 8 \[more opacity\]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose \<10 mg/day (or equivalent oral corticosteroid) were also evaluated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Week 16
Results posted on
2017-06-20
Participant Flow
The study was conducted at 18 centers in 6 countries. A total of 82 participants were screened between 30 October 2013 and 17 March 2015 of whom 58 participants were randomized and 24 were screen failures. Screen failures were mainly due to exclusion criteria met.
Participants were randomized in 2:1 ratio (Sarilumab:Placebo) and treated for 16 weeks during principal treatment period (Part A), 30 responders treated up to Week 50 with same dose during extension treatment period (Part B) while 10 non-responders and 11 participants (not completed Part A) treated with open label treatment up to Week 50 (Part C).
Participant milestones
| Measure |
Placebo
Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w (Open-Label Treatment)
Non-responders and non-completers observed in Part A were treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|---|
|
Principal Treatment Period (Part A)
STARTED
|
20
|
38
|
0
|
|
Principal Treatment Period (Part A)
COMPLETED
|
13
|
28
|
0
|
|
Principal Treatment Period (Part A)
NOT COMPLETED
|
7
|
10
|
0
|
|
Extended Treatment Period (Part B)
STARTED
|
8
|
22
|
0
|
|
Extended Treatment Period (Part B)
COMPLETED
|
7
|
12
|
0
|
|
Extended Treatment Period (Part B)
NOT COMPLETED
|
1
|
10
|
0
|
|
Open-Label Treatment Period (Part C)
STARTED
|
0
|
0
|
21
|
|
Open-Label Treatment Period (Part C)
COMPLETED
|
0
|
0
|
13
|
|
Open-Label Treatment Period (Part C)
NOT COMPLETED
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w (Open-Label Treatment)
Non-responders and non-completers observed in Part A were treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|---|
|
Principal Treatment Period (Part A)
Adverse Event
|
1
|
3
|
0
|
|
Principal Treatment Period (Part A)
Lack of Efficacy
|
6
|
6
|
0
|
|
Principal Treatment Period (Part A)
Other than specified above
|
0
|
1
|
0
|
|
Extended Treatment Period (Part B)
Adverse Event
|
0
|
2
|
0
|
|
Extended Treatment Period (Part B)
Lack of Efficacy
|
1
|
7
|
0
|
|
Extended Treatment Period (Part B)
Other than specified above
|
0
|
1
|
0
|
|
Open-Label Treatment Period (Part C)
Adverse Event
|
0
|
0
|
2
|
|
Open-Label Treatment Period (Part C)
Lack of Efficacy
|
0
|
0
|
3
|
|
Open-Label Treatment Period (Part C)
Withdrawal by Subject
|
0
|
0
|
3
|
Baseline Characteristics
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
|
Sarilumab 200 mg q2w
n=38 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C).
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population (mITT) included all randomized participants who received at least 1 injection analyzed according to the group to which the participant was allocated by the randomization schedule. Modified multiple imputation approach was used on VH missing adjudicated scores.
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 \[low opacity\] to 8 \[more opacity\]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose \<10 mg/day (or equivalent oral corticosteroid) were also evaluated.
Outcome measures
| Measure |
Placebo (Part A)
n=20 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=38 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
|
30.0 Percentage of participants
|
46.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with VH assessment at baseline and post-baseline visits.
Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 \[low opacity\] to 8 \[more opacity\]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH.
Outcome measures
| Measure |
Placebo (Part A)
n=13 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=28 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Change From Baseline in VH Scale at Week 16
|
-0.1 units on a scale
Standard Error 0.23
|
-0.9 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing AC cell score at Week 16.
Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count.
Outcome measures
| Measure |
Placebo (Part A)
n=15 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=29 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
|
86.7 Percentage of participants
|
86.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with BCVA score assessment at baseline and post-baseline visits.
BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.
Outcome measures
| Measure |
Placebo (Part A)
n=15 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=29 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
|
3.5 units on a scale
Standard Error 1.84
|
9.3 units on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.
CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.
Outcome measures
| Measure |
Placebo (Part A)
n=14 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=29 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) At Week 16
|
-8.9 µm (microns)
Standard Error 11.46
|
-35.4 µm (microns)
Standard Error 8.36
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.
CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.
Outcome measures
| Measure |
Placebo (Part A)
n=14 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=29 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Percent Change From Baseline in CRT at Week 16
|
0.0 percent change
Standard Error 2.90
|
-6.4 percent change
Standard Error 2.15
|
SECONDARY outcome
Timeframe: Week 16Population: This endpoint was replaced by the percent change from baseline in CRT at Week 16 as this is more clinically relevant. Zero participant was analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 16Population: Analysis of this endpoint was not performed as no retinal vessel leakage data was collected at Week 16. Zero participants were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 16Population: Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing data for prednisone (or equivalent oral corticosteroid) dose at Week 16.
Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated.
Outcome measures
| Measure |
Placebo (Part A)
n=15 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
n=29 Participants
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
|
40.0 Percentage of participants
|
41.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)Population: PK population: all participants who received at least one dose or part of a dose of investigational medicinal product (IMP) with at least one post-dose, non-missing serum concentration value and were analyzed according to treatment actually received. Data of this endpoint was planned to be analyzed for Sarilumab 200 mg q2w arm in Part A and B only.
Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was \<11 days or \>17 days before the sampling time for every other week regimens.
Outcome measures
| Measure |
Placebo (Part A)
n=38 Participants
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
Sarilumab 200 mg q2w (Part A)
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 16
|
19598.4 ng/mL
Standard Deviation 17280.8
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 24
|
22406.8 ng/mL
Standard Deviation 14584.2
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 36
|
24375.4 ng/mL
Standard Deviation 19121.7
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 52
|
25046.0 ng/mL
Standard Deviation 17870.7
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
EOS (Week 56)
|
1730.0 ng/mL
Standard Deviation NA
As only one participant was analyzed at EOS, standard deviation could not be calculated.
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 12
|
19705.2 ng/mL
Standard Deviation 15480.9
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Baseline
|
0.0 ng/mL
Standard Deviation 0.0
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 2
|
7383.3 ng/mL
Standard Deviation 6547.1
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 4
|
9876.6 ng/mL
Standard Deviation 8262.9
|
—
|
|
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
At Week 8
|
15958.9 ng/mL
Standard Deviation 12813.1
|
—
|
Adverse Events
Placebo (Part A + Part B)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Sarilumab 200 mg q2w (Part A+ Part B)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Sarilumab 200 mg q2w: Open-Label Treatment (Part C)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A + Part B)
n=20 participants at risk
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w (Part A+ Part B)
n=38 participants at risk
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w: Open-Label Treatment (Part C)
n=21 participants at risk
Non-responders and non-completers observed in Part A were proposed to be treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part-C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Eye disorders
Uveitis
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Staphylococcal sepsis
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Investigations
Intraocular pressure increased
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Investigations
Liver function test increased
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Vascular disorders
Deep vein thrombosis
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
Other adverse events
| Measure |
Placebo (Part A + Part B)
n=20 participants at risk
Placebo (for Sarilumab) SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w (Part A+ Part B)
n=38 participants at risk
Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B).
|
Sarilumab 200 mg q2w: Open-Label Treatment (Part C)
n=21 participants at risk
Non-responders and non-completers observed in Part A were proposed to be treated with Sarilumab 200 mg SC injection q2w for 34 weeks as open-label treatment in open-label treatment period (Part-C) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and \<80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
10.5%
4/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Eye disorders
Cataract
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Eye disorders
Retinal infiltrates
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Eye disorders
Uveitis
|
10.0%
2/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
15.8%
6/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Eye disorders
Visual impairment
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
9.5%
2/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
9.5%
2/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
14.3%
3/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
7.9%
3/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
7.9%
3/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
General disorders
Injection site bruising
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
General disorders
Injection site swelling
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
General disorders
Pyrexia
|
10.0%
2/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
10.5%
4/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
9.5%
2/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
28.6%
6/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
9.5%
2/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
20.0%
4/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
7.9%
3/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
4.8%
1/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
7.9%
3/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
10.5%
4/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
9.5%
2/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
10.5%
4/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
5.3%
2/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
0.00%
0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
|
Vascular disorders
Behcet's syndrome
|
5.0%
1/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
2.6%
1/38 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
14.3%
3/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (6 weeks after the last treatment administration [Week 56]) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of IMP to the last injection of IMP + 6 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER