Trial Outcomes & Findings for Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis (NCT NCT01061723)

NCT ID: NCT01061723

Last Updated: 2017-08-08

Results Overview

Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index \[BASFI\]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 301 participants
• Primary outcome timeframe: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
• Results posted on: 2017-08-08

Participant Flow

The study was conducted at 68 centers in Europe, Canada and the United States. A total of 563 participants were screened between 04 February 2010 and 24 February 2011. Of 563 participants, 301 were randomized and 300 were treated.

Participants were randomized in 1:1:1:1:1:1 ratio for Placebo and Sarilumab (100 mg weekly [qw]; 150 mg qw; 100 mg every other week [q2w]; 150 mg q2w and 200 mg q2w) with screening high-sensitivity C-Reactive Protein (hs-CRP) (≤1.5 mg/L or >1.5 mg/L) and region as stratification factors.

Participant milestones

Measure	Placebo Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100 mg q2w Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg q2w Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100 mg qw Sarilumab 100 mg SC injection qw for 12 weeks.	Sarilumab 200 mg q2w Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw Sarilumab 150 mg SC injection qw for 12 weeks.
Overall Study STARTED	50	49	50	52	50	50
Overall Study Treated	50	49	50	52	50	49
Overall Study COMPLETED	46	43	40	44	47	41
Overall Study NOT COMPLETED	4	6	10	8	3	9

Reasons for withdrawal

Measure	Placebo Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100 mg q2w Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg q2w Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100 mg qw Sarilumab 100 mg SC injection qw for 12 weeks.	Sarilumab 200 mg q2w Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw Sarilumab 150 mg SC injection qw for 12 weeks.
Overall Study Adverse Event	0	2	5	5	2	6
Overall Study Lack of Efficacy	2	3	4	2	1	1
Overall Study Randomized but not treated	0	0	0	0	0	1
Overall Study Other than specified above	2	1	1	1	0	1

Baseline Characteristics

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100 mg q2w n=49 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100 mg qw n=52 Participants Sarilumab 100 mg SC injection qw for 12 weeks.	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=50 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Total n=301 Participants Total of all reporting groups
Age, Continuous	40.3 years STANDARD_DEVIATION 11.7 • n=5 Participants	42.4 years STANDARD_DEVIATION 10.8 • n=7 Participants	43.0 years STANDARD_DEVIATION 11.3 • n=5 Participants	40.4 years STANDARD_DEVIATION 11.5 • n=4 Participants	37.2 years STANDARD_DEVIATION 10.4 • n=21 Participants	41.1 years STANDARD_DEVIATION 11.1 • n=8 Participants	40.7 years STANDARD_DEVIATION 11.2 • n=8 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	15 Participants n=4 Participants	10 Participants n=21 Participants	11 Participants n=8 Participants	83 Participants n=8 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	30 Participants n=7 Participants	34 Participants n=5 Participants	37 Participants n=4 Participants	40 Participants n=21 Participants	39 Participants n=8 Participants	218 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Population: Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using LOCF.

Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=50 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=49 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=52 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12	30.0 percentage of participants	38.0 percentage of participants	24.0 percentage of participants	24.5 percentage of participants	30.0 percentage of participants	19.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF.

Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=50 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=49 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=52 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12	18.0 percentage of participants	20.0 percentage of participants	8.0 percentage of participants	14.3 percentage of participants	16.0 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF.

Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=50 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=49 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=52 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12	2.0 percentage of participants	8.0 percentage of participants	2.0 percentage of participants	8.2 percentage of participants	2.0 percentage of participants	1.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASDAS score assessment at specified time-points.

ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] - 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=49 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=47 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12	-1.2 units on a scale Standard Deviation 0.9	-1.6 units on a scale Standard Deviation 0.9	-0.4 units on a scale Standard Deviation 0.7	-0.5 units on a scale Standard Deviation 0.9	-0.8 units on a scale Standard Deviation 1.2	-1.1 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with BASDAI score assessment at specified time-points.

BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=49 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=48 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in BASDAI Score at Week 12	-0.9 units on a scale Standard Deviation 1.8	-1.2 units on a scale Standard Deviation 1.8	-0.9 units on a scale Standard Deviation 1.7	-0.8 units on a scale Standard Deviation 1.9	-1.1 units on a scale Standard Deviation 2.0	-0.4 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed=participants with BASMI score assessment at specified time-points.

The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober's test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=49 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=48 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12	-0.1 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 0.9	-0.2 units on a scale Standard Deviation 0.8	-0.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population. Number of participants analyzed = participants with ASspiMRI-a assessment at specified time-points.

ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation.

Outcome measures

Measure	Sarilumab 200 mg q2w n=46 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=44 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=45 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=42 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=44 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=47 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12	-0.3 units on a scale Standard Deviation 3.3	0.3 units on a scale Standard Deviation 3.3	-0.5 units on a scale Standard Deviation 2.2	-0.5 units on a scale Standard Deviation 1.8	-0.1 units on a scale Standard Deviation 3.4	0.1 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF.

ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=50 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=49 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=52 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12	14.0 percentage of participants	32.0 percentage of participants	6.0 percentage of participants	12.2 percentage of participants	10.0 percentage of participants	13.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with chest expansion assessment at specified time-points.

The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=49 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=47 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=49 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Chest Expansion at Week 12	0.1 cm Standard Deviation 1.3	0.3 cm Standard Deviation 1.3	0.2 cm Standard Deviation 1.0	0.2 cm Standard Deviation 1.2	0.0 cm Standard Deviation 1.2	-0.1 cm Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with swollen joint count assessment at specified time-points.

44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=48 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Swollen Joint Index at Week 12	-0.4 Joints Standard Deviation 1.6	-0.2 Joints Standard Deviation 7.3	-0.4 Joints Standard Deviation 1.1	-0.8 Joints Standard Deviation 3.1	-0.3 Joints Standard Deviation 1.9	-0.3 Joints Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with Hs-CRP assessment at specified time-points.

Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=50 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=48 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in Hs-CRP at Week 12	-11.5 mg/dL Standard Deviation 17.5	-14.3 mg/dL Standard Deviation 15.3	-3.7 mg/dL Standard Deviation 19.1	-1.2 mg/dL Standard Deviation 17.9	-5.8 mg/dL Standard Deviation 27.6	-13.5 mg/dL Standard Deviation 20.3

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASAS assessment at specified time-points.

ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning.

Outcome measures

Measure	Sarilumab 200 mg q2w n=50 Participants Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150 mg qw n=49 Participants Sarilumab 150 mg SC injection qw for 12 weeks.	Placebo n=49 Participants Placebo (for sarilumab) qw for 12 weeks.	Sarilumab 100mg q2w n=48 Participants Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 150mg q2w n=50 Participants Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.	Sarilumab 100mg qw n=51 Participants Sarilumab 100 mg SC injection qw for 12 weeks.
Change From Baseline in ASAS Individual Components at Week 12 Back pain	-0.9 units on a scale Standard Deviation 2.2	-1.6 units on a scale Standard Deviation 2.1	-0.8 units on a scale Standard Deviation 1.8	-1.3 units on a scale Standard Deviation 2.2	-1.2 units on a scale Standard Deviation 2.4	-0.5 units on a scale Standard Deviation 1.8
Change From Baseline in ASAS Individual Components at Week 12 Physical function	-0.6 units on a scale Standard Deviation 1.9	-1.1 units on a scale Standard Deviation 1.9	-0.6 units on a scale Standard Deviation 1.2	-0.5 units on a scale Standard Deviation 1.7	-0.4 units on a scale Standard Deviation 2.0	-0.1 units on a scale Standard Deviation 1.4
Change From Baseline in ASAS Individual Components at Week 12 Participant global assessment	-0.9 units on a scale Standard Deviation 2.2	-1.6 units on a scale Standard Deviation 2.0	-1.0 units on a scale Standard Deviation 1.9	-1.1 units on a scale Standard Deviation 2.3	-0.8 units on a scale Standard Deviation 2.3	-0.4 units on a scale Standard Deviation 2.2
Change From Baseline in ASAS Individual Components at Week 12 Inflammation	-1.0 units on a scale Standard Deviation 1.9	-1.8 units on a scale Standard Deviation 2.3	-1.4 units on a scale Standard Deviation 1.8	-0.8 units on a scale Standard Deviation 2.0	-1.1 units on a scale Standard Deviation 2.0	-0.7 units on a scale Standard Deviation 2.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

SAR153191 100 mg q2w

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

SAR153191 150 mg q2w

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

SAR153191 100 mg qw

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

SAR153191 200 mg q2w

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

SAR153191 150 mg qw

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=50 participants at risk Placebo (for sarilumab) qw for 12 weeks.	SAR153191 100 mg q2w n=49 participants at risk Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	SAR153191 150 mg q2w n=51 participants at risk Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.	SAR153191 100 mg qw n=52 participants at risk Sarilumab 100 mg SC injection qw for 12 weeks.	SAR153191 200 mg q2w n=49 participants at risk Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.	SAR153191 150 mg qw n=49 participants at risk Sarilumab 150 mg SC injection qw for 12 weeks.
Infections and infestations Helicobacter gastritis	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	1.9% 1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Nervous system disorders Epilepsy	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Cardiac disorders Myocardial ischemia	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
General disorders Pain	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Investigations Alanine aminotransferase increased	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Investigations False positive tuberculosis test	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.

Other adverse events

Measure	Placebo n=50 participants at risk Placebo (for sarilumab) qw for 12 weeks.	SAR153191 100 mg q2w n=49 participants at risk Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks.	SAR153191 150 mg q2w n=51 participants at risk Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.	SAR153191 100 mg qw n=52 participants at risk Sarilumab 100 mg SC injection qw for 12 weeks.	SAR153191 200 mg q2w n=49 participants at risk Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error.	SAR153191 150 mg qw n=49 participants at risk Sarilumab 150 mg SC injection qw for 12 weeks.
Investigations Aspartate aminotransferase increased	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.8% 3/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Infections and infestations Nasopharyngitis	2.0% 1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	1.9% 1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Infections and infestations Upper respiratory tract infection	8.0% 4/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	13.5% 7/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	8.2% 4/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Infections and infestations Viral infection	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.9% 3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	11.8% 6/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.8% 2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	8.2% 4/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	16.3% 8/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Nervous system disorders Headache	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	8.2% 4/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.9% 3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	1.9% 1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Gastrointestinal disorders Aphthous stomatitis	2.0% 1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.9% 3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.8% 2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Gastrointestinal disorders Diarrhea	2.0% 1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	9.8% 5/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
General disorders Fatigue	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
General disorders Injection site erythema	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.8% 3/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
General disorders Injection site pruritus	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	5.8% 3/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
General disorders Injection site reaction	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.8% 2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Investigations Alanine aminotransferase increased	0.00% 0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	0.00% 0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	7.7% 4/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	8.2% 4/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Injury, poisoning and procedural complications Accidental overdose	4.0% 2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	4.1% 2/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.9% 2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	3.8% 2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	6.1% 3/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.	2.0% 1/49 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact-US@sanofi.com

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